Pilot Study Evaluating the Safety and Efficacy of a New Hard-on-Hard Total Hip Replacement System

A Consecutive Series Pilot Study Evaluating the Safety and Effectiveness of a New Hard-on-Hard Total Hip Replacement System in Patients With Non-inflammatory Arthritis With a Standard THA Metal Ion Control Group

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02154516

Enrollment

Registered

2014-06-03

Start date

2011-11-04

Completion date

2022-10-18

Last updated

2024-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthritis, Degenerative

Keywords

total hip replacement (THR), total hip arthroplasty (THA)

Brief summary

The purpose of this study is to assess the early and long term safety and efficacy of the hard-on-hard total hip replacement system (R3 ODH-ODH utilization) in patients with non-inflammatory arthritis.

Interventions

DEVICEODH Hip System

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

Healthy volunteers

Inclusion criteria

* At least 21 years old * Skeletally mature * Requires primary, unilateral total hip arthroplasty due to degenerative join disease * Preoperative Harris Hip Score of less than or equal to 70 * Meets an acceptable preoperative medical clearance and is free or treated for conditions that would pose excessive operative risk * Given consent to participate in the study * Able to understand the purpose of the study, his/her role, and is available for follow-up 10 year extension: * Subject has completed the 2 year primary study * Subject has signed an Independent Ethics Committee (IEC) approved Informed Consent Form agreeing to participate in the extension study after the nature, scope and possible consequences of the study have been explained in an understandable form * Subject is able to fully understand the purpose of the study, his/her role as a participant in the study, and plans to be available through ten years post-operative follow-up

Exclusion criteria

* Diagnosis with high risk of Total Hip Arthroplasty (THA) failure * Requires bilateral THA * Requires revision of a prior hip replacement * Active infection or sepsis * History of local hip infection * Known metastatic or neoplastic disease * Conditions that may interfere with THA survival or outcomes * Need for structural bone grafts to support the implant * Contralateral lower extremity condition * Has other joint replacements or plans for other joint replacements within 2 years * Systemic steroid therapy within 3 months prior to surgery * Life expectancy less than 2 years * Intra-articular therapy within 6 months of enrollment * Female of child-bearing age not using contraception * Inadequate bone stock to support the device * Moderate to severe renal insufficiency * Emotional or neurological condition that would pre-empt ability or willingness to participate in the study * BMI \>40 * Above the knee amputation of the contralateral or ipsilateral leg * Known allergies to the components of the devices * Entered into another investigational study * Is a prisoner 10 year extension: • In the opinion of the surgeon, the subject's health, safety or well-being may be compromised or harmed by continuation in the extension phase or participation may not be in the subject's best interests.

Design outcomes

Primary

Measure	Time frame	Description
Number of Participants With Device-Related Revisions	Postoperatively through 10 years	Device related revisions reported by the number of participants with a revision required (Yes/No).
Metal Ion Concentration in Whole Blood	3 months, 6 months, 1 year, 2 years, 5 years, 7 years and 10 years post-operatively.	For both investigational (i.e., Investigational Hard-on-Hard Total Hip Replacement Device) and control (i.e., Control Total Hip Replacement Device) participants, metal ion concentration in whole blood were measured for Cobalt (Co), Chromium (Cr), Nickel (Ni), Titanium (Ti), Zirconium (Zr), Niobium (Nb), Molybdenum (Mo), Vanadium (V) and Aluminum (Al) at each indicated time frame.

Secondary

Measure	Time frame	Description
Radiographic Measures: Radiolucencies	3 months, 6 months, 1 year, 2 years, 5 years, 7 years and 10 years post-operative	Radiolucencies determined by number of participants with occurrence of radiolucent lines and osteolysis (Yes/No)
Radiographic Measures: Heterotopic Ossification	3 months, 6 months, 1 year, 2 years, 5 years, 7 years and 10 years post-operative	Occurrence of Heterotopic Ossification in participants (Yes/No)
Radiographic Measures: Subsidence	3 months, 6 months, 1 year, 2 years, 5 years, 7 years and 10 years post-operative	Occurrence of Subsidence in Investigational Hard-on-Hard Total Hip Replacement Device participants (Yes/No) categorized by: * Acetabular Cup Subsidence * Stem Subsidence * Evidence of cortical thickening * Acetabular component fail * Femoral component fail * Other
Harris Hip Score (HHS) - Investigational Hard-on-Hard Total Hip Replacement Device Only	Preoperatively, 3 months, 6 months, 1 year, 2 years, 5 years, 7 years and 10 years post-operatively.	The Harris Hip Score (HHS), which ranges from 0 (worst) to 100 (best), considers information on pain, function, and range of motion. HHS was measured for Investigational Hard-on-Hard Total Hip Replacement Device only.
Health Economic Outcomes: Length of Hospital Stay	Hospital admission to discharge	Length of stay measured by number of days spent in hospital
Health Economic Outcomes: Operative Time	Intra-operative	Operative time in minutes from first incision into skin to time when last suture is applied for the Investigational Hard-on-Hard Total Hip Replacement Device group only
Health Economic Outcomes: Re-Hospitalizations	Up to 10 years	Re-hospitalizations measured by the number of re-admissions to hospital
Health Economic Outcomes: Surgical Blood Loss	Intra-operative, up to 50 minutes	Blood loss during surgery measured in milliliters (ml) of blood
Hip Disability and Osteoarthritis Outcome Scores (HOOS)	Preoperatively, 3 months, 6 months, 1 year, 2 years, 5 years, 7 years, 10 years	The Hip Disability and Osteoarthritis Outcome Scores (HOOS) was measured for Investigational Hard-on-Hard Total Hip Replacement Device only and included 40 items with five responses from five subcategories of Pain, Symptoms and Stiffness, Activities of Daily Living, Function in Sports and Recreational Activities, and Quality of Life to produce a total HOOS. The total HOOS scale ranged from 0 to 100, with 0 indicating the worst possible score and 100 indicating the best possible score.

Countries

South Africa

Participant flow

Participants by arm

Arm	Count
Investigational Hard-on-Hard Total Hip Replacement Device Total Hip replacement surgery using an experimental device consisting of a hard-on-hard bearing which includes: * R3 acetabular cup, and an uncemented SYNERGY or ANTHOLOGY femoral stem * R3 ODH acetabular cup liners (sizes 38/50, 40/52, 42/54 and 44/56 mm) * R3 ODH femoral heads (sizes 38, 40, 42 and 44 mm) * Taper sleeves Ti -6AL-4V (sizes -4, +0, +4, and +8)	20
Control Total Hip Replacement Device Total Hip replacement surgery using control device consisting of a hard-on-soft bearing or a ceramic-on-ceramic bearing which includes: * R3 acetabular cup, and an uncemented SYNERGY or ANTHOLOGY femoral stem * OXINIUM heads on polyethylene liners or * Ceramic heads on ceramic liners (all uncemented components)	6
Total	26

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Death	2	1
Overall Study	Lost to Follow-up	1	0
Overall Study	Removal/revision of device	1	0
Overall Study	Withdrawal by Subject	0	1

Baseline characteristics

Characteristic	Control Total Hip Replacement Device	Total	Investigational Hard-on-Hard Total Hip Replacement Device
Age, Continuous	56.3 years STANDARD_DEVIATION 13.25	51.6 years STANDARD_DEVIATION 12.67	50.2 years STANDARD_DEVIATION 12.48
Body Mass Index (BMI)	86 kg/m^2 STANDARD_DEVIATION 16.38	83.8 kg/m^2 STANDARD_DEVIATION 15.75	27 kg/m^2 STANDARD_DEVIATION 15.94
Medical History - Primary Diagnosis Avascular necrosis	0 Participants	2 Participants	2 Participants
Medical History - Primary Diagnosis Dysplasia/DDH	2 Participants	6 Participants	4 Participants
Medical History - Primary Diagnosis Missing	2 Participants	2 Participants	0 Participants
Medical History - Primary Diagnosis Osteoarthritis	2 Participants	15 Participants	13 Participants
Medical History - Primary Diagnosis Other	0 Participants	1 Participants	1 Participants
Race/Ethnicity, Customized Indian	0 Participants	2 Participants	2 Participants
Race/Ethnicity, Customized White	6 Participants	24 Participants	18 Participants
Sex: Female, Male Female	4 Participants	11 Participants	7 Participants
Sex: Female, Male Male	2 Participants	15 Participants	13 Participants
Treated Hip Side Both Left and Right (Bilateral)	0 Participants	0 Participants	0 Participants
Treated Hip Side Left Only	2 Participants	8 Participants	6 Participants
Treated Hip Side Right Only	4 Participants	18 Participants	14 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	2 / 20	1 / 6
other Total, other adverse events	20 / 20	6 / 6
serious Total, serious adverse events	9 / 20	3 / 6

Outcome results

Primary

Metal Ion Concentration in Whole Blood

For both investigational (i.e., Investigational Hard-on-Hard Total Hip Replacement Device) and control (i.e., Control Total Hip Replacement Device) participants, metal ion concentration in whole blood were measured for Cobalt (Co), Chromium (Cr), Nickel (Ni), Titanium (Ti), Zirconium (Zr), Niobium (Nb), Molybdenum (Mo), Vanadium (V) and Aluminum (Al) at each indicated time frame.

Time frame: 3 months, 6 months, 1 year, 2 years, 5 years, 7 years and 10 years post-operatively.

Population: The safety population (SAF) included all participants enrolled in the study that received the study treatment with data available at the time frame indicated.

Arm	Measure	Group	Value (MEAN)	Dispersion
Investigational Hard-on-Hard Total Hip Replacement Device	Metal Ion Concentration in Whole Blood	Cobalt (Co) Concentration in Whole Blood - 3 Months	0.2 nanograms per milliliter (ng/ml)	Standard Deviation 0.14
Investigational Hard-on-Hard Total Hip Replacement Device	Metal Ion Concentration in Whole Blood	Cobalt (Co) Concentration in Whole Blood - 6 Months	0.2 nanograms per milliliter (ng/ml)	Standard Deviation 0.09
Investigational Hard-on-Hard Total Hip Replacement Device	Metal Ion Concentration in Whole Blood	Cobalt (Co) Concentration in Whole Blood - 1 Year	0.2 nanograms per milliliter (ng/ml)	Standard Deviation 0.1
Investigational Hard-on-Hard Total Hip Replacement Device	Metal Ion Concentration in Whole Blood	Cobalt (Co) Concentration in Whole Blood - 2 Years	0.3 nanograms per milliliter (ng/ml)	Standard Deviation 0.3
Investigational Hard-on-Hard Total Hip Replacement Device	Metal Ion Concentration in Whole Blood	Cobalt (Co) Concentration in Whole Blood - 5 Years	0.1 nanograms per milliliter (ng/ml)	Standard Deviation 0.06
Investigational Hard-on-Hard Total Hip Replacement Device	Metal Ion Concentration in Whole Blood	Cobalt (Co) Concentration in Whole Blood - 7 Years	0.3 nanograms per milliliter (ng/ml)	Standard Deviation 0.17
Investigational Hard-on-Hard Total Hip Replacement Device	Metal Ion Concentration in Whole Blood	Cobalt (Co) Concentration in Whole Blood -10 Years	0.3 nanograms per milliliter (ng/ml)	Standard Deviation 0.12
Investigational Hard-on-Hard Total Hip Replacement Device	Metal Ion Concentration in Whole Blood	Chromium (Cr) Concentration in Whole Blood - 3 Months	0.5 nanograms per milliliter (ng/ml)	Standard Deviation 0.18
Investigational Hard-on-Hard Total Hip Replacement Device	Metal Ion Concentration in Whole Blood	Chromium (Cr) Concentration in Whole Blood - 6 Months	0.4 nanograms per milliliter (ng/ml)	Standard Deviation 0.04
Investigational Hard-on-Hard Total Hip Replacement Device	Metal Ion Concentration in Whole Blood	Chromium (Cr) Concentration in Whole Blood - 1 Year	0.4 nanograms per milliliter (ng/ml)	Standard Deviation 0.09
Investigational Hard-on-Hard Total Hip Replacement Device	Metal Ion Concentration in Whole Blood	Chromium (Cr) Concentration in Whole Blood - 2 Years	0.7 nanograms per milliliter (ng/ml)	Standard Deviation 0.56
Investigational Hard-on-Hard Total Hip Replacement Device	Metal Ion Concentration in Whole Blood	Chromium (Cr) Concentration in Whole Blood - 5 Years	0.6 nanograms per milliliter (ng/ml)	Standard Deviation 0.1
Investigational Hard-on-Hard Total Hip Replacement Device	Metal Ion Concentration in Whole Blood	Chromium (Cr) Concentration in Whole Blood - 7 Years	0.6 nanograms per milliliter (ng/ml)	Standard Deviation 0.21
Investigational Hard-on-Hard Total Hip Replacement Device	Metal Ion Concentration in Whole Blood	Chromium (Cr) Concentration in Whole Blood - 10 Years	0.6 nanograms per milliliter (ng/ml)	Standard Deviation 0.51
Investigational Hard-on-Hard Total Hip Replacement Device	Metal Ion Concentration in Whole Blood	Nickel (Ni) Concentration in Whole Blood - 3 Months	1.2 nanograms per milliliter (ng/ml)	Standard Deviation 2.67
Investigational Hard-on-Hard Total Hip Replacement Device	Metal Ion Concentration in Whole Blood	Nickel (Ni) Concentration in Whole Blood - 6 Months	2.3 nanograms per milliliter (ng/ml)	Standard Deviation 6.99
Investigational Hard-on-Hard Total Hip Replacement Device	Metal Ion Concentration in Whole Blood	Nickel (Ni) Concentration in Whole Blood - 1 Year	0.6 nanograms per milliliter (ng/ml)	Standard Deviation 0.2
Investigational Hard-on-Hard Total Hip Replacement Device	Metal Ion Concentration in Whole Blood	Nickel (Ni) Concentration in Whole Blood - 2 Years	0.9 nanograms per milliliter (ng/ml)	Standard Deviation 0.55
Investigational Hard-on-Hard Total Hip Replacement Device	Metal Ion Concentration in Whole Blood	Nickel (Ni) Concentration in Whole Blood - 5 Years	0.6 nanograms per milliliter (ng/ml)	Standard Deviation 0.22
Investigational Hard-on-Hard Total Hip Replacement Device	Metal Ion Concentration in Whole Blood	Nickel (Ni) Concentration in Whole Blood - 7 Years	0.9 nanograms per milliliter (ng/ml)	Standard Deviation 0.29
Investigational Hard-on-Hard Total Hip Replacement Device	Metal Ion Concentration in Whole Blood	Nickel (Ni) Concentration in Whole Blood - 10 Years	0.7 nanograms per milliliter (ng/ml)	Standard Deviation 0.18
Investigational Hard-on-Hard Total Hip Replacement Device	Metal Ion Concentration in Whole Blood	Titanium (Ti) Concentration in Whole Blood - 3 Months	1.5 nanograms per milliliter (ng/ml)	Standard Deviation 0.62
Investigational Hard-on-Hard Total Hip Replacement Device	Metal Ion Concentration in Whole Blood	Titanium (Ti) Concentration in Whole Blood - 6 Months	1.5 nanograms per milliliter (ng/ml)	Standard Deviation 0.41
Investigational Hard-on-Hard Total Hip Replacement Device	Metal Ion Concentration in Whole Blood	Titanium (Ti) Concentration in Whole Blood - 1 Year	1.7 nanograms per milliliter (ng/ml)	Standard Deviation 0.35
Investigational Hard-on-Hard Total Hip Replacement Device	Metal Ion Concentration in Whole Blood	Titanium (Ti) Concentration in Whole Blood - 2 Years	1.5 nanograms per milliliter (ng/ml)	Standard Deviation 0.66
Investigational Hard-on-Hard Total Hip Replacement Device	Metal Ion Concentration in Whole Blood	Titanium (Ti) Concentration in Whole Blood - 5 Years	1.8 nanograms per milliliter (ng/ml)	Standard Deviation 1.12
Investigational Hard-on-Hard Total Hip Replacement Device	Metal Ion Concentration in Whole Blood	Titanium (Ti) Concentration in Whole Blood - 7 Years	1.7 nanograms per milliliter (ng/ml)	Standard Deviation 0.6
Investigational Hard-on-Hard Total Hip Replacement Device	Metal Ion Concentration in Whole Blood	Titanium (Ti) Concentration in Whole Blood - 10 Years	1.3 nanograms per milliliter (ng/ml)	Standard Deviation 0.52
Investigational Hard-on-Hard Total Hip Replacement Device	Metal Ion Concentration in Whole Blood	Zirconium (Zr) Concentration in Whole Blood - 3 Months	0.6 nanograms per milliliter (ng/ml)	Standard Deviation 0.3
Investigational Hard-on-Hard Total Hip Replacement Device	Metal Ion Concentration in Whole Blood	Zirconium (Zr) Concentration in Whole Blood - 6 Months	0.4 nanograms per milliliter (ng/ml)	Standard Deviation 0.11
Investigational Hard-on-Hard Total Hip Replacement Device	Metal Ion Concentration in Whole Blood	Zirconium (Zr) Concentration in Whole Blood - 1 Year	0.3 nanograms per milliliter (ng/ml)	Standard Deviation 0.15
Investigational Hard-on-Hard Total Hip Replacement Device	Metal Ion Concentration in Whole Blood	Zirconium (Zr) Concentration in Whole Blood - 2 Years	0.5 nanograms per milliliter (ng/ml)	Standard Deviation 0.27
Investigational Hard-on-Hard Total Hip Replacement Device	Metal Ion Concentration in Whole Blood	Zirconium (Zr) Concentration in Whole Blood - 5 Years	0.4 nanograms per milliliter (ng/ml)	Standard Deviation 0.3
Investigational Hard-on-Hard Total Hip Replacement Device	Metal Ion Concentration in Whole Blood	Zirconium (Zr) Concentration in Whole Blood - 7 Years	0.8 nanograms per milliliter (ng/ml)	Standard Deviation 0.64
Investigational Hard-on-Hard Total Hip Replacement Device	Metal Ion Concentration in Whole Blood	Zirconium (Zr) Concentration in Whole Blood - 10 Years	0.5 nanograms per milliliter (ng/ml)	Standard Deviation 0.49
Investigational Hard-on-Hard Total Hip Replacement Device	Metal Ion Concentration in Whole Blood	Niobium (Nb) Concentration in Whole Blood - 3 Months	0.1 nanograms per milliliter (ng/ml)	Standard Deviation 0.02
Investigational Hard-on-Hard Total Hip Replacement Device	Metal Ion Concentration in Whole Blood	Niobium (Nb) Concentration in Whole Blood - 6 Months	0.1 nanograms per milliliter (ng/ml)	Standard Deviation 0.02
Investigational Hard-on-Hard Total Hip Replacement Device	Metal Ion Concentration in Whole Blood	Niobium (Nb) Concentration in Whole Blood - 1 Year	0.1 nanograms per milliliter (ng/ml)	Standard Deviation 0
Investigational Hard-on-Hard Total Hip Replacement Device	Metal Ion Concentration in Whole Blood	Niobium (Nb) Concentration in Whole Blood - 2 Years	0.1 nanograms per milliliter (ng/ml)	Standard Deviation 0.01
Investigational Hard-on-Hard Total Hip Replacement Device	Metal Ion Concentration in Whole Blood	Niobium (Nb) Concentration in Whole Blood - 5 Years	0.1 nanograms per milliliter (ng/ml)	Standard Deviation 0
Investigational Hard-on-Hard Total Hip Replacement Device	Metal Ion Concentration in Whole Blood	Niobium (Nb) Concentration in Whole Blood - 7 Years	0.2 nanograms per milliliter (ng/ml)	Standard Deviation 0.28
Investigational Hard-on-Hard Total Hip Replacement Device	Metal Ion Concentration in Whole Blood	Niobium (Nb) Concentration in Whole Blood - 10 Years	0.1 nanograms per milliliter (ng/ml)	Standard Deviation 0.01
Investigational Hard-on-Hard Total Hip Replacement Device	Metal Ion Concentration in Whole Blood	Molybdenum (Mo) Concentration in Whole Blood - 3 Months	1.1 nanograms per milliliter (ng/ml)	Standard Deviation 0.61
Investigational Hard-on-Hard Total Hip Replacement Device	Metal Ion Concentration in Whole Blood	Molybdenum (Mo) Concentration in Whole Blood - 6 Months	0.8 nanograms per milliliter (ng/ml)	Standard Deviation 0.52
Investigational Hard-on-Hard Total Hip Replacement Device	Metal Ion Concentration in Whole Blood	Molybdenum (Mo) Concentration in Whole Blood - 1 Year	0.5 nanograms per milliliter (ng/ml)	Standard Deviation 0.14
Investigational Hard-on-Hard Total Hip Replacement Device	Metal Ion Concentration in Whole Blood	Molybdenum (Mo) Concentration in Whole Blood - 2 Years	0.9 nanograms per milliliter (ng/ml)	Standard Deviation 0.44
Investigational Hard-on-Hard Total Hip Replacement Device	Metal Ion Concentration in Whole Blood	Molybdenum (Mo) Concentration in Whole Blood - 5 Years	0.7 nanograms per milliliter (ng/ml)	Standard Deviation 0.39
Investigational Hard-on-Hard Total Hip Replacement Device	Metal Ion Concentration in Whole Blood	Molybdenum (Mo) Concentration in Whole Blood - 7 Years	1.0 nanograms per milliliter (ng/ml)	Standard Deviation 0.96
Investigational Hard-on-Hard Total Hip Replacement Device	Metal Ion Concentration in Whole Blood	Molybdenum (Mo) Concentration in Whole Blood - 10 Years	0.6 nanograms per milliliter (ng/ml)	Standard Deviation 0.31
Investigational Hard-on-Hard Total Hip Replacement Device	Metal Ion Concentration in Whole Blood	Vanadium (V) Concentration in Whole Blood - 3 Months	0.1 nanograms per milliliter (ng/ml)	Standard Deviation 0.17
Investigational Hard-on-Hard Total Hip Replacement Device	Metal Ion Concentration in Whole Blood	Vanadium (V) Concentration in Whole Blood - 6 Months	0.1 nanograms per milliliter (ng/ml)	Standard Deviation 0.05
Investigational Hard-on-Hard Total Hip Replacement Device	Metal Ion Concentration in Whole Blood	Vanadium (V) Concentration in Whole Blood - 1 Year	0.1 nanograms per milliliter (ng/ml)	Standard Deviation 0.06
Investigational Hard-on-Hard Total Hip Replacement Device	Metal Ion Concentration in Whole Blood	Vanadium (V) Concentration in Whole Blood - 2 Years	0.1 nanograms per milliliter (ng/ml)	Standard Deviation 0.04
Investigational Hard-on-Hard Total Hip Replacement Device	Metal Ion Concentration in Whole Blood	Vanadium (V) Concentration in Whole Blood - 5 Years	0.3 nanograms per milliliter (ng/ml)	Standard Deviation 0.65
Investigational Hard-on-Hard Total Hip Replacement Device	Metal Ion Concentration in Whole Blood	Vanadium (V) Concentration in Whole Blood - 7 Years	0.2 nanograms per milliliter (ng/ml)	Standard Deviation 0.06
Investigational Hard-on-Hard Total Hip Replacement Device	Metal Ion Concentration in Whole Blood	Vanadium (V) Concentration in Whole Blood - 10 Years	0.1 nanograms per milliliter (ng/ml)	Standard Deviation 0.14
Investigational Hard-on-Hard Total Hip Replacement Device	Metal Ion Concentration in Whole Blood	Aluminum (Al) Concentration in Whole Blood - 3 Months	5.8 nanograms per milliliter (ng/ml)	Standard Deviation 1.61
Investigational Hard-on-Hard Total Hip Replacement Device	Metal Ion Concentration in Whole Blood	Aluminum (Al) Concentration in Whole Blood - 6 Months	7.0 nanograms per milliliter (ng/ml)	Standard Deviation 3.8
Investigational Hard-on-Hard Total Hip Replacement Device	Metal Ion Concentration in Whole Blood	Aluminum (Al) Concentration in Whole Blood - 1 Year	8.5 nanograms per milliliter (ng/ml)	Standard Deviation 4.62
Investigational Hard-on-Hard Total Hip Replacement Device	Metal Ion Concentration in Whole Blood	Aluminum (Al) Concentration in Whole Blood - 2 Years	11.2 nanograms per milliliter (ng/ml)	Standard Deviation 6.86
Investigational Hard-on-Hard Total Hip Replacement Device	Metal Ion Concentration in Whole Blood	Aluminum (Al) Concentration in Whole Blood - 5 Years	10.4 nanograms per milliliter (ng/ml)	Standard Deviation 7.2
Investigational Hard-on-Hard Total Hip Replacement Device	Metal Ion Concentration in Whole Blood	Aluminum (Al) Concentration in Whole Blood - 7 Years	15.0 nanograms per milliliter (ng/ml)	Standard Deviation 10.5
Investigational Hard-on-Hard Total Hip Replacement Device	Metal Ion Concentration in Whole Blood	Aluminum (Al) Concentration in Whole Blood - 10 Years	11.0 nanograms per milliliter (ng/ml)	Standard Deviation 7.02
Control Total Hip Replacement Device	Metal Ion Concentration in Whole Blood	Zirconium (Zr) Concentration in Whole Blood - 2 Years	0.3 nanograms per milliliter (ng/ml)	Standard Deviation 0.33
Control Total Hip Replacement Device	Metal Ion Concentration in Whole Blood	Cobalt (Co) Concentration in Whole Blood - 3 Months	0.3 nanograms per milliliter (ng/ml)	Standard Deviation 0.32
Control Total Hip Replacement Device	Metal Ion Concentration in Whole Blood	Molybdenum (Mo) Concentration in Whole Blood - 7 Years	0.6 nanograms per milliliter (ng/ml)	Standard Deviation 0.64
Control Total Hip Replacement Device	Metal Ion Concentration in Whole Blood	Cobalt (Co) Concentration in Whole Blood - 6 Months	0.2 nanograms per milliliter (ng/ml)	Standard Deviation 0.08
Control Total Hip Replacement Device	Metal Ion Concentration in Whole Blood	Zirconium (Zr) Concentration in Whole Blood - 5 Years	0.2 nanograms per milliliter (ng/ml)	Standard Deviation 0.05
Control Total Hip Replacement Device	Metal Ion Concentration in Whole Blood	Cobalt (Co) Concentration in Whole Blood - 1 Year	0.2 nanograms per milliliter (ng/ml)	Standard Deviation 0.1
Control Total Hip Replacement Device	Metal Ion Concentration in Whole Blood	Vanadium (V) Concentration in Whole Blood - 10 Years	0.3 nanograms per milliliter (ng/ml)	Standard Deviation 0.19
Control Total Hip Replacement Device	Metal Ion Concentration in Whole Blood	Cobalt (Co) Concentration in Whole Blood - 2 Years	0.2 nanograms per milliliter (ng/ml)	Standard Deviation 0.12
Control Total Hip Replacement Device	Metal Ion Concentration in Whole Blood	Zirconium (Zr) Concentration in Whole Blood - 7 Years	0.3 nanograms per milliliter (ng/ml)	Standard Deviation 0.16
Control Total Hip Replacement Device	Metal Ion Concentration in Whole Blood	Cobalt (Co) Concentration in Whole Blood - 5 Years	0.1 nanograms per milliliter (ng/ml)	Standard Deviation 0.07
Control Total Hip Replacement Device	Metal Ion Concentration in Whole Blood	Molybdenum (Mo) Concentration in Whole Blood - 10 Years	0.8 nanograms per milliliter (ng/ml)	Standard Deviation 0.55
Control Total Hip Replacement Device	Metal Ion Concentration in Whole Blood	Cobalt (Co) Concentration in Whole Blood - 7 Years	1.0 nanograms per milliliter (ng/ml)	Standard Deviation 1.56
Control Total Hip Replacement Device	Metal Ion Concentration in Whole Blood	Zirconium (Zr) Concentration in Whole Blood - 10 Years	0.2 nanograms per milliliter (ng/ml)	Standard Deviation 0.21
Control Total Hip Replacement Device	Metal Ion Concentration in Whole Blood	Cobalt (Co) Concentration in Whole Blood -10 Years	0.2 nanograms per milliliter (ng/ml)	Standard Deviation 0.06
Control Total Hip Replacement Device	Metal Ion Concentration in Whole Blood	Aluminum (Al) Concentration in Whole Blood - 2 Years	7.2 nanograms per milliliter (ng/ml)	Standard Deviation 2.07
Control Total Hip Replacement Device	Metal Ion Concentration in Whole Blood	Chromium (Cr) Concentration in Whole Blood - 3 Months	0.5 nanograms per milliliter (ng/ml)	Standard Deviation 0.16
Control Total Hip Replacement Device	Metal Ion Concentration in Whole Blood	Niobium (Nb) Concentration in Whole Blood - 3 Months	0.1 nanograms per milliliter (ng/ml)	Standard Deviation 0.01
Control Total Hip Replacement Device	Metal Ion Concentration in Whole Blood	Chromium (Cr) Concentration in Whole Blood - 6 Months	0.4 nanograms per milliliter (ng/ml)	Standard Deviation 0.01
Control Total Hip Replacement Device	Metal Ion Concentration in Whole Blood	Vanadium (V) Concentration in Whole Blood - 3 Months	0.1 nanograms per milliliter (ng/ml)	Standard Deviation 0
Control Total Hip Replacement Device	Metal Ion Concentration in Whole Blood	Chromium (Cr) Concentration in Whole Blood - 1 Year	0.4 nanograms per milliliter (ng/ml)	Standard Deviation 0.07
Control Total Hip Replacement Device	Metal Ion Concentration in Whole Blood	Niobium (Nb) Concentration in Whole Blood - 6 Months	0.1 nanograms per milliliter (ng/ml)	Standard Deviation 0
Control Total Hip Replacement Device	Metal Ion Concentration in Whole Blood	Chromium (Cr) Concentration in Whole Blood - 2 Years	0.6 nanograms per milliliter (ng/ml)	Standard Deviation 0.25
Control Total Hip Replacement Device	Metal Ion Concentration in Whole Blood	Aluminum (Al) Concentration in Whole Blood - 3 Months	5.9 nanograms per milliliter (ng/ml)	Standard Deviation 1.96
Control Total Hip Replacement Device	Metal Ion Concentration in Whole Blood	Chromium (Cr) Concentration in Whole Blood - 5 Years	0.6 nanograms per milliliter (ng/ml)	Standard Deviation 0.26
Control Total Hip Replacement Device	Metal Ion Concentration in Whole Blood	Niobium (Nb) Concentration in Whole Blood - 1 Year	0.1 nanograms per milliliter (ng/ml)	Standard Deviation 0
Control Total Hip Replacement Device	Metal Ion Concentration in Whole Blood	Chromium (Cr) Concentration in Whole Blood - 7 Years	0.8 nanograms per milliliter (ng/ml)	Standard Deviation 0.51
Control Total Hip Replacement Device	Metal Ion Concentration in Whole Blood	Vanadium (V) Concentration in Whole Blood - 6 Months	0.1 nanograms per milliliter (ng/ml)	Standard Deviation 0
Control Total Hip Replacement Device	Metal Ion Concentration in Whole Blood	Chromium (Cr) Concentration in Whole Blood - 10 Years	0.7 nanograms per milliliter (ng/ml)	Standard Deviation 0.38
Control Total Hip Replacement Device	Metal Ion Concentration in Whole Blood	Niobium (Nb) Concentration in Whole Blood - 2 Years	0.1 nanograms per milliliter (ng/ml)	Standard Deviation 0.01
Control Total Hip Replacement Device	Metal Ion Concentration in Whole Blood	Nickel (Ni) Concentration in Whole Blood - 3 Months	0.9 nanograms per milliliter (ng/ml)	Standard Deviation 0.59
Control Total Hip Replacement Device	Metal Ion Concentration in Whole Blood	Aluminum (Al) Concentration in Whole Blood - 7 Years	10.0 nanograms per milliliter (ng/ml)	Standard Deviation 5.98
Control Total Hip Replacement Device	Metal Ion Concentration in Whole Blood	Nickel (Ni) Concentration in Whole Blood - 6 Months	0.5 nanograms per milliliter (ng/ml)	Standard Deviation 0
Control Total Hip Replacement Device	Metal Ion Concentration in Whole Blood	Niobium (Nb) Concentration in Whole Blood - 5 Years	0.1 nanograms per milliliter (ng/ml)	Standard Deviation 0.02
Control Total Hip Replacement Device	Metal Ion Concentration in Whole Blood	Nickel (Ni) Concentration in Whole Blood - 1 Year	0.5 nanograms per milliliter (ng/ml)	Standard Deviation 0.05
Control Total Hip Replacement Device	Metal Ion Concentration in Whole Blood	Vanadium (V) Concentration in Whole Blood - 1 Year	0.1 nanograms per milliliter (ng/ml)	Standard Deviation 0
Control Total Hip Replacement Device	Metal Ion Concentration in Whole Blood	Nickel (Ni) Concentration in Whole Blood - 2 Years	0.6 nanograms per milliliter (ng/ml)	Standard Deviation 0.12
Control Total Hip Replacement Device	Metal Ion Concentration in Whole Blood	Niobium (Nb) Concentration in Whole Blood - 7 Years	0.1 nanograms per milliliter (ng/ml)	Standard Deviation 0.03
Control Total Hip Replacement Device	Metal Ion Concentration in Whole Blood	Nickel (Ni) Concentration in Whole Blood - 5 Years	0.8 nanograms per milliliter (ng/ml)	Standard Deviation 0.57
Control Total Hip Replacement Device	Metal Ion Concentration in Whole Blood	Aluminum (Al) Concentration in Whole Blood - 6 Months	6.1 nanograms per milliliter (ng/ml)	Standard Deviation 0.98
Control Total Hip Replacement Device	Metal Ion Concentration in Whole Blood	Nickel (Ni) Concentration in Whole Blood - 7 Years	0.9 nanograms per milliliter (ng/ml)	Standard Deviation 0.85
Control Total Hip Replacement Device	Metal Ion Concentration in Whole Blood	Niobium (Nb) Concentration in Whole Blood - 10 Years	0.0 nanograms per milliliter (ng/ml)	Standard Deviation 0.01
Control Total Hip Replacement Device	Metal Ion Concentration in Whole Blood	Nickel (Ni) Concentration in Whole Blood - 10 Years	1.5 nanograms per milliliter (ng/ml)	Standard Deviation 1.16
Control Total Hip Replacement Device	Metal Ion Concentration in Whole Blood	Vanadium (V) Concentration in Whole Blood - 2 Years	0.1 nanograms per milliliter (ng/ml)	Standard Deviation 0.01
Control Total Hip Replacement Device	Metal Ion Concentration in Whole Blood	Titanium (Ti) Concentration in Whole Blood - 3 Months	1.4 nanograms per milliliter (ng/ml)	Standard Deviation 0.63
Control Total Hip Replacement Device	Metal Ion Concentration in Whole Blood	Molybdenum (Mo) Concentration in Whole Blood - 3 Months	0.9 nanograms per milliliter (ng/ml)	Standard Deviation 0.51
Control Total Hip Replacement Device	Metal Ion Concentration in Whole Blood	Titanium (Ti) Concentration in Whole Blood - 6 Months	1.9 nanograms per milliliter (ng/ml)	Standard Deviation 0.91
Control Total Hip Replacement Device	Metal Ion Concentration in Whole Blood	Aluminum (Al) Concentration in Whole Blood - 5 Years	9.4 nanograms per milliliter (ng/ml)	Standard Deviation 9.93
Control Total Hip Replacement Device	Metal Ion Concentration in Whole Blood	Titanium (Ti) Concentration in Whole Blood - 1 Year	2.3 nanograms per milliliter (ng/ml)	Standard Deviation 1.1
Control Total Hip Replacement Device	Metal Ion Concentration in Whole Blood	Molybdenum (Mo) Concentration in Whole Blood - 6 Months	0.7 nanograms per milliliter (ng/ml)	Standard Deviation 0.29
Control Total Hip Replacement Device	Metal Ion Concentration in Whole Blood	Titanium (Ti) Concentration in Whole Blood - 2 Years	1.7 nanograms per milliliter (ng/ml)	Standard Deviation 0.28
Control Total Hip Replacement Device	Metal Ion Concentration in Whole Blood	Vanadium (V) Concentration in Whole Blood - 5 Years	0.01 nanograms per milliliter (ng/ml)	Standard Deviation 0.03
Control Total Hip Replacement Device	Metal Ion Concentration in Whole Blood	Titanium (Ti) Concentration in Whole Blood - 5 Years	1.8 nanograms per milliliter (ng/ml)	Standard Deviation 0.3
Control Total Hip Replacement Device	Metal Ion Concentration in Whole Blood	Molybdenum (Mo) Concentration in Whole Blood - 1 Year	0.5 nanograms per milliliter (ng/ml)	Standard Deviation 0.25
Control Total Hip Replacement Device	Metal Ion Concentration in Whole Blood	Titanium (Ti) Concentration in Whole Blood - 7 Years	1.4 nanograms per milliliter (ng/ml)	Standard Deviation 0.75
Control Total Hip Replacement Device	Metal Ion Concentration in Whole Blood	Aluminum (Al) Concentration in Whole Blood - 1 Year	10.3 nanograms per milliliter (ng/ml)	Standard Deviation 5.01
Control Total Hip Replacement Device	Metal Ion Concentration in Whole Blood	Titanium (Ti) Concentration in Whole Blood - 10 Years	2.3 nanograms per milliliter (ng/ml)	Standard Deviation 1.89
Control Total Hip Replacement Device	Metal Ion Concentration in Whole Blood	Molybdenum (Mo) Concentration in Whole Blood - 2 Years	0.6 nanograms per milliliter (ng/ml)	Standard Deviation 0.09
Control Total Hip Replacement Device	Metal Ion Concentration in Whole Blood	Zirconium (Zr) Concentration in Whole Blood - 3 Months	0.2 nanograms per milliliter (ng/ml)	Standard Deviation 0.07
Control Total Hip Replacement Device	Metal Ion Concentration in Whole Blood	Vanadium (V) Concentration in Whole Blood - 7 Years	0.2 nanograms per milliliter (ng/ml)	Standard Deviation 0.09
Control Total Hip Replacement Device	Metal Ion Concentration in Whole Blood	Zirconium (Zr) Concentration in Whole Blood - 6 Months	0.1 nanograms per milliliter (ng/ml)	Standard Deviation 0.03
Control Total Hip Replacement Device	Metal Ion Concentration in Whole Blood	Molybdenum (Mo) Concentration in Whole Blood - 5 Years	0.5 nanograms per milliliter (ng/ml)	Standard Deviation 0.14
Control Total Hip Replacement Device	Metal Ion Concentration in Whole Blood	Zirconium (Zr) Concentration in Whole Blood - 1 Year	0.1 nanograms per milliliter (ng/ml)	Standard Deviation 0.05
Control Total Hip Replacement Device	Metal Ion Concentration in Whole Blood	Aluminum (Al) Concentration in Whole Blood - 10 Years	7.1 nanograms per milliliter (ng/ml)	Standard Deviation 1.32

Primary

Number of Participants With Device-Related Revisions

Device related revisions reported by the number of participants with a revision required (Yes/No).

Time frame: Postoperatively through 10 years

Population: The safety population (SAF) included all participants enrolled in the study that received the study treatment with data available at the time frame indicated.

Arm	Measure	Category	Value (COUNT_OF_PARTICIPANTS)
Investigational Hard-on-Hard Total Hip Replacement Device	Number of Participants With Device-Related Revisions	Revision Required: Yes	1 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Number of Participants With Device-Related Revisions	Revision Required: No	19 Participants
Control Total Hip Replacement Device	Number of Participants With Device-Related Revisions	Revision Required: Yes	0 Participants
Control Total Hip Replacement Device	Number of Participants With Device-Related Revisions	Revision Required: No	6 Participants

Secondary

Harris Hip Score (HHS) - Investigational Hard-on-Hard Total Hip Replacement Device Only

The Harris Hip Score (HHS), which ranges from 0 (worst) to 100 (best), considers information on pain, function, and range of motion. HHS was measured for Investigational Hard-on-Hard Total Hip Replacement Device only.

Time frame: Preoperatively, 3 months, 6 months, 1 year, 2 years, 5 years, 7 years and 10 years post-operatively.

Population: The Intent to Treat (ITT) population included participants enrolled in the study with data available at the time frame indicated. The ITT did not include those that only provided retrospective data, therefore only data for the Investigational Hard-on-Hard Total Hip Replacement Device group was collected.

Arm	Measure	Group	Value (MEAN)	Dispersion
Investigational Hard-on-Hard Total Hip Replacement Device	Harris Hip Score (HHS) - Investigational Hard-on-Hard Total Hip Replacement Device Only	Preoperative	51.0 score on a scale	Standard Deviation 9.48
Investigational Hard-on-Hard Total Hip Replacement Device	Harris Hip Score (HHS) - Investigational Hard-on-Hard Total Hip Replacement Device Only	3 Months	85.6 score on a scale	Standard Deviation 11.28
Investigational Hard-on-Hard Total Hip Replacement Device	Harris Hip Score (HHS) - Investigational Hard-on-Hard Total Hip Replacement Device Only	6 Months	92.6 score on a scale	Standard Deviation 9.77
Investigational Hard-on-Hard Total Hip Replacement Device	Harris Hip Score (HHS) - Investigational Hard-on-Hard Total Hip Replacement Device Only	1 Year	94.7 score on a scale	Standard Deviation 9.79
Investigational Hard-on-Hard Total Hip Replacement Device	Harris Hip Score (HHS) - Investigational Hard-on-Hard Total Hip Replacement Device Only	2 Years	95.2 score on a scale	Standard Deviation 10.21
Investigational Hard-on-Hard Total Hip Replacement Device	Harris Hip Score (HHS) - Investigational Hard-on-Hard Total Hip Replacement Device Only	5 Years	92.9 score on a scale	Standard Deviation 14.44
Investigational Hard-on-Hard Total Hip Replacement Device	Harris Hip Score (HHS) - Investigational Hard-on-Hard Total Hip Replacement Device Only	7 Years	94.9 score on a scale	Standard Deviation 12.6
Investigational Hard-on-Hard Total Hip Replacement Device	Harris Hip Score (HHS) - Investigational Hard-on-Hard Total Hip Replacement Device Only	10 Years	97.1 score on a scale	Standard Deviation 9.35

Secondary

Health Economic Outcomes: Length of Hospital Stay

Length of stay measured by number of days spent in hospital

Time frame: Hospital admission to discharge

Population: Length of hospital stay data was not collected as part of the 10 year extension study.

Secondary

Health Economic Outcomes: Operative Time

Operative time in minutes from first incision into skin to time when last suture is applied for the Investigational Hard-on-Hard Total Hip Replacement Device group only

Time frame: Intra-operative

Arm	Measure	Value (MEAN)	Dispersion
Investigational Hard-on-Hard Total Hip Replacement Device	Health Economic Outcomes: Operative Time	50.0 Minutes	Standard Deviation 14.9

Secondary

Health Economic Outcomes: Re-Hospitalizations

Re-hospitalizations measured by the number of re-admissions to hospital

Time frame: Up to 10 years

Population: Re-hospitalizations data was not collected as part of the 10 year extension study.

Secondary

Health Economic Outcomes: Surgical Blood Loss

Blood loss during surgery measured in milliliters (ml) of blood

Time frame: Intra-operative, up to 50 minutes

Population: The safety population (SAF) included all participants enrolled in the study that received the study treatment with data available at the time frame indicated.

Arm	Measure	Value (MEAN)	Dispersion
Investigational Hard-on-Hard Total Hip Replacement Device	Health Economic Outcomes: Surgical Blood Loss	324 milliliters (mL)	Standard Deviation 218.6
Control Total Hip Replacement Device	Health Economic Outcomes: Surgical Blood Loss	365 milliliters (mL)	Standard Deviation 164.2

Secondary

Hip Disability and Osteoarthritis Outcome Scores (HOOS)

The Hip Disability and Osteoarthritis Outcome Scores (HOOS) was measured for Investigational Hard-on-Hard Total Hip Replacement Device only and included 40 items with five responses from five subcategories of Pain, Symptoms and Stiffness, Activities of Daily Living, Function in Sports and Recreational Activities, and Quality of Life to produce a total HOOS. The total HOOS scale ranged from 0 to 100, with 0 indicating the worst possible score and 100 indicating the best possible score.

Time frame: Preoperatively, 3 months, 6 months, 1 year, 2 years, 5 years, 7 years, 10 years

Arm	Measure	Group	Value (MEAN)	Dispersion
Investigational Hard-on-Hard Total Hip Replacement Device	Hip Disability and Osteoarthritis Outcome Scores (HOOS)	Preoperative	44.9 score on a scale	Standard Deviation 19.86
Investigational Hard-on-Hard Total Hip Replacement Device	Hip Disability and Osteoarthritis Outcome Scores (HOOS)	3 Months	83.8 score on a scale	Standard Deviation 18.84
Investigational Hard-on-Hard Total Hip Replacement Device	Hip Disability and Osteoarthritis Outcome Scores (HOOS)	6 Months	85.8 score on a scale	Standard Deviation 21.08
Investigational Hard-on-Hard Total Hip Replacement Device	Hip Disability and Osteoarthritis Outcome Scores (HOOS)	1 Year	91.8 score on a scale	Standard Deviation 14.53
Investigational Hard-on-Hard Total Hip Replacement Device	Hip Disability and Osteoarthritis Outcome Scores (HOOS)	2 Years	92.9 score on a scale	Standard Deviation 14.07
Investigational Hard-on-Hard Total Hip Replacement Device	Hip Disability and Osteoarthritis Outcome Scores (HOOS)	5 Years	85.6 score on a scale	Standard Deviation 26.91
Investigational Hard-on-Hard Total Hip Replacement Device	Hip Disability and Osteoarthritis Outcome Scores (HOOS)	7 Years	88.8 score on a scale	Standard Deviation 22.95
Investigational Hard-on-Hard Total Hip Replacement Device	Hip Disability and Osteoarthritis Outcome Scores (HOOS)	10 Years	88.4 score on a scale	Standard Deviation 22.87

Secondary

Radiographic Measures: Heterotopic Ossification

Occurrence of Heterotopic Ossification in participants (Yes/No)

Time frame: 3 months, 6 months, 1 year, 2 years, 5 years, 7 years and 10 years post-operative

Population: The safety population (SAF) included all participants enrolled in the study that received the study treatment with data available at the time frame indicated. Data was not collected for the control total hip replacement device group at 3 months, 6 months, 1 year, and 2 years.

Arm	Measure	Group	Category	Value (COUNT_OF_PARTICIPANTS)
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Heterotopic Ossification	Heterotopic Ossification - 6 Months	Heterotopic Ossification Grade 4	0 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Heterotopic Ossification	Heterotopic Ossification - 2 Years	Heterotopic Ossification Grade 3	0 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Heterotopic Ossification	Heterotopic Ossification - 3 Months	Heterotopic Ossification Grade 1	2 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Heterotopic Ossification	Heterotopic Ossification - 2 Years	Heterotopic Ossification Grade 4	0 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Heterotopic Ossification	Heterotopic Ossification - 1 Year	No Heterotopic Ossification	14 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Heterotopic Ossification	Heterotopic Ossification - 5 Years	No Heterotopic Ossification	16 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Heterotopic Ossification	Heterotopic Ossification - 3 Months	Heterotopic Ossification Grade 4	0 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Heterotopic Ossification	Heterotopic Ossification - 5 Years	Heterotopic Ossification Grade 1	1 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Heterotopic Ossification	Heterotopic Ossification - 1 Year	Heterotopic Ossification Grade 1	4 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Heterotopic Ossification	Heterotopic Ossification - 5 Years	Heterotopic Ossification Grade 2	1 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Heterotopic Ossification	Heterotopic Ossification - 3 Months	No Heterotopic Ossification	18 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Heterotopic Ossification	Heterotopic Ossification - 5 Years	Heterotopic Ossification Grade 3	0 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Heterotopic Ossification	Heterotopic Ossification - 1 Year	Heterotopic Ossification Grade 2	1 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Heterotopic Ossification	Heterotopic Ossification - 5 Years	Heterotopic Ossification Grade 4	0 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Heterotopic Ossification	Heterotopic Ossification - 3 Months	Heterotopic Ossification Grade 2	0 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Heterotopic Ossification	Heterotopic Ossification - 7 Years	No Heterotopic Ossification	14 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Heterotopic Ossification	Heterotopic Ossification - 1 Year	Heterotopic Ossification Grade 3	0 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Heterotopic Ossification	Heterotopic Ossification - 7 Years	Heterotopic Ossification Grade 1	2 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Heterotopic Ossification	Heterotopic Ossification - 6 Months	Heterotopic Ossification Grade 2	1 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Heterotopic Ossification	Heterotopic Ossification - 7 Years	Heterotopic Ossification Grade 2	1 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Heterotopic Ossification	Heterotopic Ossification - 1 Year	Heterotopic Ossification Grade 4	0 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Heterotopic Ossification	Heterotopic Ossification - 7 Years	Heterotopic Ossification Grade 3	0 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Heterotopic Ossification	Heterotopic Ossification - 6 Months	Heterotopic Ossification Grade 1	3 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Heterotopic Ossification	Heterotopic Ossification - 7 Years	Heterotopic Ossification Grade 4	0 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Heterotopic Ossification	Heterotopic Ossification - 2 Years	No Heterotopic Ossification	18 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Heterotopic Ossification	Heterotopic Ossification - 10 Years	No Heterotopic Ossification	13 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Heterotopic Ossification	Heterotopic Ossification - 6 Months	Heterotopic Ossification Grade 3	0 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Heterotopic Ossification	Heterotopic Ossification - 10 Years	Heterotopic Ossification Grade 1	0 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Heterotopic Ossification	Heterotopic Ossification - 2 Years	Heterotopic Ossification Grade 1	0 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Heterotopic Ossification	Heterotopic Ossification - 10 Years	Heterotopic Ossification Grade 2	1 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Heterotopic Ossification	Heterotopic Ossification - 3 Months	Heterotopic Ossification Grade 3	0 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Heterotopic Ossification	Heterotopic Ossification - 10 Years	Heterotopic Ossification Grade 3	0 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Heterotopic Ossification	Heterotopic Ossification - 2 Years	Heterotopic Ossification Grade 2	1 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Heterotopic Ossification	Heterotopic Ossification - 10 Years	Heterotopic Ossification Grade 4	0 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Heterotopic Ossification	Heterotopic Ossification - 6 Months	No Heterotopic Ossification	15 Participants
Control Total Hip Replacement Device	Radiographic Measures: Heterotopic Ossification	Heterotopic Ossification - 10 Years	Heterotopic Ossification Grade 4	0 Participants
Control Total Hip Replacement Device	Radiographic Measures: Heterotopic Ossification	Heterotopic Ossification - 6 Months	No Heterotopic Ossification	0 Participants
Control Total Hip Replacement Device	Radiographic Measures: Heterotopic Ossification	Heterotopic Ossification - 3 Months	No Heterotopic Ossification	0 Participants
Control Total Hip Replacement Device	Radiographic Measures: Heterotopic Ossification	Heterotopic Ossification - 3 Months	Heterotopic Ossification Grade 1	0 Participants
Control Total Hip Replacement Device	Radiographic Measures: Heterotopic Ossification	Heterotopic Ossification - 3 Months	Heterotopic Ossification Grade 2	0 Participants
Control Total Hip Replacement Device	Radiographic Measures: Heterotopic Ossification	Heterotopic Ossification - 3 Months	Heterotopic Ossification Grade 3	0 Participants
Control Total Hip Replacement Device	Radiographic Measures: Heterotopic Ossification	Heterotopic Ossification - 3 Months	Heterotopic Ossification Grade 4	0 Participants
Control Total Hip Replacement Device	Radiographic Measures: Heterotopic Ossification	Heterotopic Ossification - 6 Months	Heterotopic Ossification Grade 1	0 Participants
Control Total Hip Replacement Device	Radiographic Measures: Heterotopic Ossification	Heterotopic Ossification - 6 Months	Heterotopic Ossification Grade 2	0 Participants
Control Total Hip Replacement Device	Radiographic Measures: Heterotopic Ossification	Heterotopic Ossification - 6 Months	Heterotopic Ossification Grade 3	0 Participants
Control Total Hip Replacement Device	Radiographic Measures: Heterotopic Ossification	Heterotopic Ossification - 6 Months	Heterotopic Ossification Grade 4	0 Participants
Control Total Hip Replacement Device	Radiographic Measures: Heterotopic Ossification	Heterotopic Ossification - 1 Year	No Heterotopic Ossification	0 Participants
Control Total Hip Replacement Device	Radiographic Measures: Heterotopic Ossification	Heterotopic Ossification - 1 Year	Heterotopic Ossification Grade 1	0 Participants
Control Total Hip Replacement Device	Radiographic Measures: Heterotopic Ossification	Heterotopic Ossification - 1 Year	Heterotopic Ossification Grade 2	0 Participants
Control Total Hip Replacement Device	Radiographic Measures: Heterotopic Ossification	Heterotopic Ossification - 1 Year	Heterotopic Ossification Grade 3	0 Participants
Control Total Hip Replacement Device	Radiographic Measures: Heterotopic Ossification	Heterotopic Ossification - 1 Year	Heterotopic Ossification Grade 4	0 Participants
Control Total Hip Replacement Device	Radiographic Measures: Heterotopic Ossification	Heterotopic Ossification - 2 Years	No Heterotopic Ossification	0 Participants
Control Total Hip Replacement Device	Radiographic Measures: Heterotopic Ossification	Heterotopic Ossification - 2 Years	Heterotopic Ossification Grade 1	0 Participants
Control Total Hip Replacement Device	Radiographic Measures: Heterotopic Ossification	Heterotopic Ossification - 2 Years	Heterotopic Ossification Grade 2	0 Participants
Control Total Hip Replacement Device	Radiographic Measures: Heterotopic Ossification	Heterotopic Ossification - 2 Years	Heterotopic Ossification Grade 3	0 Participants
Control Total Hip Replacement Device	Radiographic Measures: Heterotopic Ossification	Heterotopic Ossification - 2 Years	Heterotopic Ossification Grade 4	0 Participants
Control Total Hip Replacement Device	Radiographic Measures: Heterotopic Ossification	Heterotopic Ossification - 5 Years	No Heterotopic Ossification	4 Participants
Control Total Hip Replacement Device	Radiographic Measures: Heterotopic Ossification	Heterotopic Ossification - 5 Years	Heterotopic Ossification Grade 1	0 Participants
Control Total Hip Replacement Device	Radiographic Measures: Heterotopic Ossification	Heterotopic Ossification - 5 Years	Heterotopic Ossification Grade 2	1 Participants
Control Total Hip Replacement Device	Radiographic Measures: Heterotopic Ossification	Heterotopic Ossification - 5 Years	Heterotopic Ossification Grade 3	0 Participants
Control Total Hip Replacement Device	Radiographic Measures: Heterotopic Ossification	Heterotopic Ossification - 5 Years	Heterotopic Ossification Grade 4	0 Participants
Control Total Hip Replacement Device	Radiographic Measures: Heterotopic Ossification	Heterotopic Ossification - 7 Years	No Heterotopic Ossification	2 Participants
Control Total Hip Replacement Device	Radiographic Measures: Heterotopic Ossification	Heterotopic Ossification - 7 Years	Heterotopic Ossification Grade 1	2 Participants
Control Total Hip Replacement Device	Radiographic Measures: Heterotopic Ossification	Heterotopic Ossification - 7 Years	Heterotopic Ossification Grade 2	0 Participants
Control Total Hip Replacement Device	Radiographic Measures: Heterotopic Ossification	Heterotopic Ossification - 7 Years	Heterotopic Ossification Grade 3	0 Participants
Control Total Hip Replacement Device	Radiographic Measures: Heterotopic Ossification	Heterotopic Ossification - 7 Years	Heterotopic Ossification Grade 4	0 Participants
Control Total Hip Replacement Device	Radiographic Measures: Heterotopic Ossification	Heterotopic Ossification - 10 Years	No Heterotopic Ossification	2 Participants
Control Total Hip Replacement Device	Radiographic Measures: Heterotopic Ossification	Heterotopic Ossification - 10 Years	Heterotopic Ossification Grade 1	2 Participants
Control Total Hip Replacement Device	Radiographic Measures: Heterotopic Ossification	Heterotopic Ossification - 10 Years	Heterotopic Ossification Grade 2	0 Participants
Control Total Hip Replacement Device	Radiographic Measures: Heterotopic Ossification	Heterotopic Ossification - 10 Years	Heterotopic Ossification Grade 3	0 Participants

Secondary

Radiographic Measures: Radiolucencies

Radiolucencies determined by number of participants with occurrence of radiolucent lines and osteolysis (Yes/No)

Time frame: 3 months, 6 months, 1 year, 2 years, 5 years, 7 years and 10 years post-operative

Arm	Measure	Group	Category	Value (COUNT_OF_PARTICIPANTS)
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Radiolucencies	Osteolysis - 2 Years	No	17 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Radiolucencies	Radiolucent Line - 6 months	No	19 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Radiolucencies	Osteolysis - 2 Years	Yes	2 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Radiolucencies	Radiolucent Line - 1 Year	No	15 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Radiolucencies	Radiolucent Line - 5 Years	No	18 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Radiolucencies	Radiolucent Line - 3 months	Yes	3 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Radiolucencies	Radiolucent Line - 5 Years	Yes	0 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Radiolucencies	Radiolucent Line - 1 Year	Yes	4 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Radiolucencies	Osteolysis - 5 Years	No	18 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Radiolucencies	Radiolucent Line - 6 months	Yes	0 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Radiolucencies	Osteolysis - 5 Years	Yes	0 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Radiolucencies	Osteolysis - 1 Year	No	13 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Radiolucencies	Radiolucent Line - 7 Years	No	16 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Radiolucencies	Osteolysis - 3 months	Yes	3 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Radiolucencies	Radiolucent Line - 7 Years	Yes	1 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Radiolucencies	Osteolysis - 1 Year	Yes	6 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Radiolucencies	Osteolysis - 7 Years	No	16 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Radiolucencies	Osteolysis - 6 months	No	18 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Radiolucencies	Osteolysis - 7 Years	Yes	1 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Radiolucencies	Radiolucent Line - 2 Years	No	17 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Radiolucencies	Radiolucent Line - 10 Years	No	14 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Radiolucencies	Osteolysis - 3 months	No	17 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Radiolucencies	Radiolucent Line - 10 Years	Yes	0 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Radiolucencies	Radiolucent Line - 2 Years	Yes	2 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Radiolucencies	Osteolysis - 10 Years	No	14 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Radiolucencies	Osteolysis - 6 months	Yes	1 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Radiolucencies	Osteolysis - 10 Years	Yes	0 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Radiolucencies	Radiolucent Line - 3 months	No	17 Participants
Control Total Hip Replacement Device	Radiographic Measures: Radiolucencies	Osteolysis - 10 Years	Yes	0 Participants
Control Total Hip Replacement Device	Radiographic Measures: Radiolucencies	Radiolucent Line - 3 months	No	0 Participants
Control Total Hip Replacement Device	Radiographic Measures: Radiolucencies	Radiolucent Line - 3 months	Yes	0 Participants
Control Total Hip Replacement Device	Radiographic Measures: Radiolucencies	Osteolysis - 3 months	No	0 Participants
Control Total Hip Replacement Device	Radiographic Measures: Radiolucencies	Osteolysis - 3 months	Yes	0 Participants
Control Total Hip Replacement Device	Radiographic Measures: Radiolucencies	Radiolucent Line - 6 months	No	0 Participants
Control Total Hip Replacement Device	Radiographic Measures: Radiolucencies	Radiolucent Line - 6 months	Yes	0 Participants
Control Total Hip Replacement Device	Radiographic Measures: Radiolucencies	Osteolysis - 6 months	No	0 Participants
Control Total Hip Replacement Device	Radiographic Measures: Radiolucencies	Osteolysis - 6 months	Yes	0 Participants
Control Total Hip Replacement Device	Radiographic Measures: Radiolucencies	Radiolucent Line - 1 Year	No	0 Participants
Control Total Hip Replacement Device	Radiographic Measures: Radiolucencies	Radiolucent Line - 1 Year	Yes	0 Participants
Control Total Hip Replacement Device	Radiographic Measures: Radiolucencies	Osteolysis - 1 Year	No	0 Participants
Control Total Hip Replacement Device	Radiographic Measures: Radiolucencies	Osteolysis - 1 Year	Yes	0 Participants
Control Total Hip Replacement Device	Radiographic Measures: Radiolucencies	Radiolucent Line - 2 Years	No	0 Participants
Control Total Hip Replacement Device	Radiographic Measures: Radiolucencies	Radiolucent Line - 2 Years	Yes	0 Participants
Control Total Hip Replacement Device	Radiographic Measures: Radiolucencies	Osteolysis - 2 Years	No	0 Participants
Control Total Hip Replacement Device	Radiographic Measures: Radiolucencies	Osteolysis - 2 Years	Yes	0 Participants
Control Total Hip Replacement Device	Radiographic Measures: Radiolucencies	Radiolucent Line - 5 Years	No	5 Participants
Control Total Hip Replacement Device	Radiographic Measures: Radiolucencies	Radiolucent Line - 5 Years	Yes	0 Participants
Control Total Hip Replacement Device	Radiographic Measures: Radiolucencies	Osteolysis - 5 Years	No	5 Participants
Control Total Hip Replacement Device	Radiographic Measures: Radiolucencies	Osteolysis - 5 Years	Yes	0 Participants
Control Total Hip Replacement Device	Radiographic Measures: Radiolucencies	Radiolucent Line - 7 Years	No	4 Participants
Control Total Hip Replacement Device	Radiographic Measures: Radiolucencies	Radiolucent Line - 7 Years	Yes	0 Participants
Control Total Hip Replacement Device	Radiographic Measures: Radiolucencies	Osteolysis - 7 Years	No	4 Participants
Control Total Hip Replacement Device	Radiographic Measures: Radiolucencies	Osteolysis - 7 Years	Yes	0 Participants
Control Total Hip Replacement Device	Radiographic Measures: Radiolucencies	Radiolucent Line - 10 Years	No	4 Participants
Control Total Hip Replacement Device	Radiographic Measures: Radiolucencies	Radiolucent Line - 10 Years	Yes	0 Participants
Control Total Hip Replacement Device	Radiographic Measures: Radiolucencies	Osteolysis - 10 Years	No	4 Participants

Secondary

Radiographic Measures: Subsidence

Occurrence of Subsidence in Investigational Hard-on-Hard Total Hip Replacement Device participants (Yes/No) categorized by: * Acetabular Cup Subsidence * Stem Subsidence * Evidence of cortical thickening * Acetabular component fail * Femoral component fail * Other

Time frame: 3 months, 6 months, 1 year, 2 years, 5 years, 7 years and 10 years post-operative

Population: The safety population (SAF) included all participants enrolled in the study that received the study treatment with data available at the time frame indicated. The safety population (SAF) included all participants enrolled in the study that received the study treatment with data available at the time frame indicated. Data was not collected for the control total hip replacement device group at 3 months, 6 months, 1 year, and 2 years.

Arm	Measure	Group	Category	Value (COUNT_OF_PARTICIPANTS)
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Subsidence	Acetabular component fail - 2 Years	No	19 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Subsidence	Femoral component fail - 6 Months	Yes	0 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Subsidence	Acetabular component fail - 2 Years	Yes	0 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Subsidence	Evidence of cortical thickening - 3 Months	No	20 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Subsidence	Femoral component fail - 2 Years	No	19 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Subsidence	Other- 6 Months	No	19 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Subsidence	Femoral component fail - 2 Years	Yes	0 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Subsidence	Evidence of cortical thickening - 2 Years	No	19 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Subsidence	Other - 2 Years	No	18 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Subsidence	Other - 3 Months	Yes	0 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Subsidence	Other - 2 Years	Yes	1 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Subsidence	Other- 6 Months	Yes	0 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Subsidence	Acetabular Cup Subsidence - 5 Years	No	18 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Subsidence	Acetabular Cup Subsidence - 3 months	No	20 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Subsidence	Acetabular Cup Subsidence - 5 Years	Yes	0 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Subsidence	Acetabular Cup Subsidence - 1 Year	No	19 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Subsidence	Stem Subsidence - 5 Years	No	17 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Subsidence	Acetabular Cup Subsidence - 6 months	No	19 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Subsidence	Stem Subsidence - 5 Years	Yes	1 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Subsidence	Acetabular Cup Subsidence - 1 Year	Yes	0 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Subsidence	Evidence of cortical thickening - 5 Years	No	18 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Subsidence	Evidence of cortical thickening - 3 Months	Yes	0 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Subsidence	Evidence of cortical thickening - 5 Years	Yes	0 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Subsidence	Stem Subsidence - 1 Year	No	19 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Subsidence	Acetabular component fail - 5 Years	No	18 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Subsidence	Acetabular Cup Subsidence - 6 months	Yes	0 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Subsidence	Acetabular component fail - 5 Years	Yes	0 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Subsidence	Stem Subsidence - 1 Year	Yes	0 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Subsidence	Femoral component fail - 5 Years	No	18 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Subsidence	Stem Subsidence - 3 months	No	20 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Subsidence	Femoral component fail - 5 Years	Yes	0 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Subsidence	Evidence of cortical thickening - 1 Year	No	19 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Subsidence	Other - 5 Years	No	17 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Subsidence	Stem Subsidence - 6 Months	No	19 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Subsidence	Other - 5 Years	Yes	1 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Subsidence	Evidence of cortical thickening - 1 Year	Yes	0 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Subsidence	Acetabular Cup Subsidence - 7 Years	No	17 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Subsidence	Acetabular component fail - 3 Months	No	20 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Subsidence	Acetabular Cup Subsidence - 7 Years	Yes	0 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Subsidence	Acetabular component fail - 1 Year	No	19 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Subsidence	Stem Subsidence - 7 Years	No	17 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Subsidence	Stem Subsidence - 6 Months	Yes	0 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Subsidence	Stem Subsidence - 7 Years	Yes	0 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Subsidence	Acetabular component fail - 1 Year	Yes	0 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Subsidence	Evidence of cortical thickening - 7 Years	No	16 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Subsidence	Femoral component fail - 3 Months	No	20 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Subsidence	Evidence of cortical thickening - 7 Years	Yes	1 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Subsidence	Femoral component fail - 1 Year	No	19 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Subsidence	Acetabular component fail - 7 Years	No	17 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Subsidence	Evidence of cortical thickening - 6 Months	No	18 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Subsidence	Acetabular component fail - 7 Years	Yes	0 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Subsidence	Femoral component fail - 1 Year	Yes	0 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Subsidence	Femoral component fail - 7 Years	No	17 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Subsidence	Acetabular component fail - 3 Months	Yes	0 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Subsidence	Femoral component fail - 7 Years	Yes	0 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Subsidence	Other - 1 Year	No	19 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Subsidence	Other - 7 Years	No	17 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Subsidence	Evidence of cortical thickening - 6 Months	Yes	1 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Subsidence	Other - 7 Years	Yes	0 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Subsidence	Other - 1 Year	Yes	0 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Subsidence	Acetabular Cup Subsidence - 10 Years	No	14 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Subsidence	Stem Subsidence - 3 months	Yes	0 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Subsidence	Acetabular Cup Subsidence - 10 Years	Yes	0 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Subsidence	Acetabular Cup Subsidence - 2 Years	No	19 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Subsidence	Stem Subsidence - 10 Years	No	14 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Subsidence	Acetabular component fail - 6 Months	No	19 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Subsidence	Stem Subsidence - 10 Years	Yes	0 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Subsidence	Acetabular Cup Subsidence - 2 Years	Yes	0 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Subsidence	Evidence of cortical thickening - 10 Years	No	13 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Subsidence	Femoral component fail - 3 Months	Yes	0 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Subsidence	Evidence of cortical thickening - 10 Years	Yes	1 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Subsidence	Stem Subsidence 2 Years	No	19 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Subsidence	Acetabular component fail - 10 Years	No	14 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Subsidence	Acetabular component fail - 6 Months	Yes	0 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Subsidence	Acetabular component fail - 10 Years	Yes	0 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Subsidence	Stem Subsidence 2 Years	Yes	0 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Subsidence	Femoral component fail - 10 Years	No	14 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Subsidence	Acetabular Cup Subsidence - 3 months	Yes	0 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Subsidence	Femoral component fail - 10 Years	Yes	0 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Subsidence	Femoral component fail - 6 Months	No	19 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Subsidence	Other - 10 Years	No	14 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Subsidence	Evidence of cortical thickening - 2 Years	Yes	0 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Subsidence	Other - 10 Years	Yes	0 Participants
Investigational Hard-on-Hard Total Hip Replacement Device	Radiographic Measures: Subsidence	Other - 3 Months	No	20 Participants
Control Total Hip Replacement Device	Radiographic Measures: Subsidence	Other - 10 Years	Yes	0 Participants
Control Total Hip Replacement Device	Radiographic Measures: Subsidence	Acetabular Cup Subsidence - 3 months	No	0 Participants
Control Total Hip Replacement Device	Radiographic Measures: Subsidence	Acetabular Cup Subsidence - 3 months	Yes	0 Participants
Control Total Hip Replacement Device	Radiographic Measures: Subsidence	Stem Subsidence - 3 months	No	0 Participants
Control Total Hip Replacement Device	Radiographic Measures: Subsidence	Stem Subsidence - 3 months	Yes	0 Participants
Control Total Hip Replacement Device	Radiographic Measures: Subsidence	Evidence of cortical thickening - 3 Months	No	0 Participants
Control Total Hip Replacement Device	Radiographic Measures: Subsidence	Evidence of cortical thickening - 3 Months	Yes	0 Participants
Control Total Hip Replacement Device	Radiographic Measures: Subsidence	Acetabular component fail - 3 Months	No	0 Participants
Control Total Hip Replacement Device	Radiographic Measures: Subsidence	Femoral component fail - 3 Months	No	0 Participants
Control Total Hip Replacement Device	Radiographic Measures: Subsidence	Femoral component fail - 3 Months	Yes	0 Participants
Control Total Hip Replacement Device	Radiographic Measures: Subsidence	Other - 3 Months	No	0 Participants
Control Total Hip Replacement Device	Radiographic Measures: Subsidence	Other - 3 Months	Yes	0 Participants
Control Total Hip Replacement Device	Radiographic Measures: Subsidence	Acetabular Cup Subsidence - 6 months	No	0 Participants
Control Total Hip Replacement Device	Radiographic Measures: Subsidence	Acetabular Cup Subsidence - 6 months	Yes	0 Participants
Control Total Hip Replacement Device	Radiographic Measures: Subsidence	Stem Subsidence - 6 Months	No	0 Participants
Control Total Hip Replacement Device	Radiographic Measures: Subsidence	Stem Subsidence - 6 Months	Yes	0 Participants
Control Total Hip Replacement Device	Radiographic Measures: Subsidence	Evidence of cortical thickening - 6 Months	No	0 Participants
Control Total Hip Replacement Device	Radiographic Measures: Subsidence	Evidence of cortical thickening - 6 Months	Yes	0 Participants
Control Total Hip Replacement Device	Radiographic Measures: Subsidence	Acetabular component fail - 6 Months	No	0 Participants
Control Total Hip Replacement Device	Radiographic Measures: Subsidence	Acetabular component fail - 6 Months	Yes	0 Participants
Control Total Hip Replacement Device	Radiographic Measures: Subsidence	Femoral component fail - 6 Months	No	0 Participants
Control Total Hip Replacement Device	Radiographic Measures: Subsidence	Femoral component fail - 6 Months	Yes	0 Participants
Control Total Hip Replacement Device	Radiographic Measures: Subsidence	Other- 6 Months	No	0 Participants
Control Total Hip Replacement Device	Radiographic Measures: Subsidence	Other- 6 Months	Yes	0 Participants
Control Total Hip Replacement Device	Radiographic Measures: Subsidence	Acetabular Cup Subsidence - 1 Year	No	0 Participants
Control Total Hip Replacement Device	Radiographic Measures: Subsidence	Acetabular Cup Subsidence - 1 Year	Yes	0 Participants
Control Total Hip Replacement Device	Radiographic Measures: Subsidence	Stem Subsidence - 1 Year	No	0 Participants
Control Total Hip Replacement Device	Radiographic Measures: Subsidence	Stem Subsidence - 1 Year	Yes	0 Participants
Control Total Hip Replacement Device	Radiographic Measures: Subsidence	Evidence of cortical thickening - 1 Year	No	0 Participants
Control Total Hip Replacement Device	Radiographic Measures: Subsidence	Evidence of cortical thickening - 1 Year	Yes	0 Participants
Control Total Hip Replacement Device	Radiographic Measures: Subsidence	Acetabular component fail - 1 Year	No	0 Participants
Control Total Hip Replacement Device	Radiographic Measures: Subsidence	Acetabular component fail - 1 Year	Yes	0 Participants
Control Total Hip Replacement Device	Radiographic Measures: Subsidence	Femoral component fail - 1 Year	No	0 Participants
Control Total Hip Replacement Device	Radiographic Measures: Subsidence	Femoral component fail - 1 Year	Yes	0 Participants
Control Total Hip Replacement Device	Radiographic Measures: Subsidence	Other - 1 Year	No	0 Participants
Control Total Hip Replacement Device	Radiographic Measures: Subsidence	Other - 1 Year	Yes	0 Participants
Control Total Hip Replacement Device	Radiographic Measures: Subsidence	Acetabular Cup Subsidence - 2 Years	No	0 Participants
Control Total Hip Replacement Device	Radiographic Measures: Subsidence	Acetabular Cup Subsidence - 2 Years	Yes	0 Participants
Control Total Hip Replacement Device	Radiographic Measures: Subsidence	Stem Subsidence 2 Years	No	0 Participants
Control Total Hip Replacement Device	Radiographic Measures: Subsidence	Stem Subsidence 2 Years	Yes	0 Participants
Control Total Hip Replacement Device	Radiographic Measures: Subsidence	Evidence of cortical thickening - 2 Years	No	0 Participants
Control Total Hip Replacement Device	Radiographic Measures: Subsidence	Evidence of cortical thickening - 2 Years	Yes	0 Participants
Control Total Hip Replacement Device	Radiographic Measures: Subsidence	Acetabular component fail - 2 Years	No	0 Participants
Control Total Hip Replacement Device	Radiographic Measures: Subsidence	Acetabular component fail - 2 Years	Yes	0 Participants
Control Total Hip Replacement Device	Radiographic Measures: Subsidence	Femoral component fail - 2 Years	No	0 Participants
Control Total Hip Replacement Device	Radiographic Measures: Subsidence	Femoral component fail - 2 Years	Yes	0 Participants
Control Total Hip Replacement Device	Radiographic Measures: Subsidence	Other - 2 Years	No	0 Participants
Control Total Hip Replacement Device	Radiographic Measures: Subsidence	Other - 2 Years	Yes	0 Participants
Control Total Hip Replacement Device	Radiographic Measures: Subsidence	Acetabular Cup Subsidence - 5 Years	No	5 Participants
Control Total Hip Replacement Device	Radiographic Measures: Subsidence	Acetabular Cup Subsidence - 5 Years	Yes	0 Participants
Control Total Hip Replacement Device	Radiographic Measures: Subsidence	Stem Subsidence - 5 Years	No	5 Participants
Control Total Hip Replacement Device	Radiographic Measures: Subsidence	Stem Subsidence - 5 Years	Yes	0 Participants
Control Total Hip Replacement Device	Radiographic Measures: Subsidence	Evidence of cortical thickening - 5 Years	No	4 Participants
Control Total Hip Replacement Device	Radiographic Measures: Subsidence	Evidence of cortical thickening - 5 Years	Yes	1 Participants
Control Total Hip Replacement Device	Radiographic Measures: Subsidence	Acetabular component fail - 5 Years	No	5 Participants
Control Total Hip Replacement Device	Radiographic Measures: Subsidence	Acetabular component fail - 5 Years	Yes	0 Participants
Control Total Hip Replacement Device	Radiographic Measures: Subsidence	Femoral component fail - 5 Years	No	5 Participants
Control Total Hip Replacement Device	Radiographic Measures: Subsidence	Femoral component fail - 5 Years	Yes	0 Participants
Control Total Hip Replacement Device	Radiographic Measures: Subsidence	Other - 5 Years	No	5 Participants
Control Total Hip Replacement Device	Radiographic Measures: Subsidence	Other - 5 Years	Yes	0 Participants
Control Total Hip Replacement Device	Radiographic Measures: Subsidence	Acetabular Cup Subsidence - 7 Years	No	4 Participants
Control Total Hip Replacement Device	Radiographic Measures: Subsidence	Acetabular Cup Subsidence - 7 Years	Yes	0 Participants
Control Total Hip Replacement Device	Radiographic Measures: Subsidence	Stem Subsidence - 7 Years	No	4 Participants
Control Total Hip Replacement Device	Radiographic Measures: Subsidence	Stem Subsidence - 7 Years	Yes	0 Participants
Control Total Hip Replacement Device	Radiographic Measures: Subsidence	Evidence of cortical thickening - 7 Years	No	4 Participants
Control Total Hip Replacement Device	Radiographic Measures: Subsidence	Evidence of cortical thickening - 7 Years	Yes	0 Participants
Control Total Hip Replacement Device	Radiographic Measures: Subsidence	Acetabular component fail - 7 Years	No	4 Participants
Control Total Hip Replacement Device	Radiographic Measures: Subsidence	Acetabular component fail - 7 Years	Yes	0 Participants
Control Total Hip Replacement Device	Radiographic Measures: Subsidence	Femoral component fail - 7 Years	No	4 Participants
Control Total Hip Replacement Device	Radiographic Measures: Subsidence	Femoral component fail - 7 Years	Yes	0 Participants
Control Total Hip Replacement Device	Radiographic Measures: Subsidence	Other - 7 Years	No	4 Participants
Control Total Hip Replacement Device	Radiographic Measures: Subsidence	Other - 7 Years	Yes	0 Participants
Control Total Hip Replacement Device	Radiographic Measures: Subsidence	Acetabular Cup Subsidence - 10 Years	No	4 Participants
Control Total Hip Replacement Device	Radiographic Measures: Subsidence	Acetabular Cup Subsidence - 10 Years	Yes	0 Participants
Control Total Hip Replacement Device	Radiographic Measures: Subsidence	Stem Subsidence - 10 Years	No	4 Participants
Control Total Hip Replacement Device	Radiographic Measures: Subsidence	Stem Subsidence - 10 Years	Yes	0 Participants
Control Total Hip Replacement Device	Radiographic Measures: Subsidence	Evidence of cortical thickening - 10 Years	No	4 Participants
Control Total Hip Replacement Device	Radiographic Measures: Subsidence	Evidence of cortical thickening - 10 Years	Yes	0 Participants
Control Total Hip Replacement Device	Radiographic Measures: Subsidence	Acetabular component fail - 10 Years	No	4 Participants
Control Total Hip Replacement Device	Radiographic Measures: Subsidence	Acetabular component fail - 10 Years	Yes	0 Participants
Control Total Hip Replacement Device	Radiographic Measures: Subsidence	Femoral component fail - 10 Years	No	4 Participants
Control Total Hip Replacement Device	Radiographic Measures: Subsidence	Femoral component fail - 10 Years	Yes	0 Participants
Control Total Hip Replacement Device	Radiographic Measures: Subsidence	Other - 10 Years	No	4 Participants
Control Total Hip Replacement Device	Radiographic Measures: Subsidence	Acetabular component fail - 3 Months	Yes	0 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026

Pilot Study Evaluating the Safety and Efficacy of a New Hard-on-Hard Total Hip Replacement System

Conditions

Keywords

Brief summary

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Metal Ion Concentration in Whole Blood

Number of Participants With Device-Related Revisions

Harris Hip Score (HHS) - Investigational Hard-on-Hard Total Hip Replacement Device Only

Health Economic Outcomes: Length of Hospital Stay

Health Economic Outcomes: Operative Time

Health Economic Outcomes: Re-Hospitalizations

Health Economic Outcomes: Surgical Blood Loss

Hip Disability and Osteoarthritis Outcome Scores (HOOS)

Radiographic Measures: Heterotopic Ossification

Radiographic Measures: Radiolucencies

Radiographic Measures: Subsidence