R3 Delta Ceramic Acetabular System PAS U.S.

Post-Approval Study of the R3 Biolox Delta Ceramic Acetabular System - US

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03056534

Acronym

R3-PAS

Enrollment

189

Registered

2017-02-17

Start date

2018-02-07

Completion date

2023-05-31

Last updated

2025-04-13

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

Conditions

Degenerative Joint Disease

Keywords

Primary Total Hip Arthroplasty, Non-Inflammatory Arthritis, Degenerative Joint Disease, R3 Delta Ceramic Acetabular Insert

Brief summary

R3 Delta Post-Approval Study U.S.

Detailed description

Post-Approval Study of the R3 Biolox Delta Ceramic Acetabular System - US The R3 Ceramic Acetabular System is indicated for use in skeletally mature patients requiring primary total hip arthroplasty due to non-inflammatory arthritis (degenerative joint disease) such as osteoarthritis, avascular necrosis, or traumatic arthritis. The expected timeline for the study is a total of approximately 5 years: 6 months for site initiation, 12 months for subject enrollment, 3 years until the last subject enrolled has reached the 3 year follow-up interval.

Interventions

DEVICER3 Biolox Delta Ceramic Acetabular System

All study related procedures with the R3 delta Ceramic Acetabular System must be performed according to the recommended surgical technique described in the labeling and in the instructions for use (IFU).

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Inclusion criteria

* Patient is 18-75 years old and he/she is skeletally mature * Patient requires primary total hip arthroplasty due to non-inflammatory degenerative joint disease (degenerative joint disease) such as osteoarthritis, avascular necrosis, or traumatic arthritis. * Patient has met an acceptable preoperative medical clearance and is free from or treated for cardiac, pulmonary, hematological, etc., conditions that would pose excessive operative risk * Patient is willing and able to participate in required follow-up visits and to complete study procedures and questionnaires * Patient has consented to participating in the study by signing the IRB/EC approved informed consent form

Exclusion criteria

* Patients with insufficient quantity or quality of bone support; metabolic bone disease; osteoporosis * Patients with neurological or muscular conditions that would place extreme load or instability upon the hip joint * Patients with active joint infections or chronic systemic infection * Obese patients where obesity is defined as BMI ≥ 40 * Skeletal immaturity * Known allergy to implant materials

Design outcomes

Primary

Measure	Time frame	Description
Number of Participants With Absence of Acetabular Cup Inclination Changes Greater Than 4 Degrees From Baseline at 3 Years Postoperative	3 Years postoperative	Number of participants identified as Success or Failure with success defined as no acetabular cup inclination changes greater than 4 degrees from baseline when accompanied by a Mild, Moderate, Marked or Disabled mHHS pain score.
Component Revisions at 3 Years Postoperative	3 Years Postoperative	Number of participants component revisions identified as Success or Failure with success defined as no component revision for any reason.
Number of Participants With Modified Harris Hip Score Greater Than or Equal to 80 Points	3 Years postoperative	The Harris Hip Score (HHS) is a joint specific score that consists of 10 items covering domains of pain, function, functional activities, absence of deformity, and hip range of motion. The modified Harris Hip Score (mHHS) includes all the same domains as the HHS except for the hip range of motion. Total mHHS scale ranges from 0 (worst) to 95 (best). The number of participants were identified as Success or Failure with success defined as a mHHS that is greater than or equal to 80 points.
Overall Radiographic Success at 3 Years Postoperative	3 Years Postoperative	Number of participants with overall radiographic success identified as Success or Failure where success indicated all of the following: * No radiolucencies greater than 2 millimeters (mm) in 50% or more in any of the cup or stem zones * No femoral or acetabular subsidence greater than or equal to 5 mm from baseline * No acetabular cup inclination changes greater than 4 degrees from baseline when accompanied by a Mild, Moderate, Marked or Disabled mHHS pain score
Number of Participants With Absence of Radiolucency at 3 Years Postoperative	3 Years postoperative	Number of participants identified as Success or Failure with success defined as no radiolucencies greater than 2 millimeters (mm) in 50% or more in any of the cup or stem zones
Number of Participants With Absence of Femoral Subsidence or Acetabular Migration at 3 Years Postoperative	3 Years postoperative	Number of participants identified as Success or Failure with success defined as no femoral subsidence or acetabular migration greater than or equal to 5 millimeters (mm) from baseline.
Overall Study Success at 3 Years Postoperative	3 Years Postoperative	Number of participants with overall study success were identified as Success or Failure where success indicated all the following: * No component revision for any reason * Modified Harris Hip Score (mHHS) greater than or equal to 80 points * No radiographic failure (Radiographic failure was defined as no radiolucencies greater than 2 millimeters (mm) in 50% or more in any of the cup or stem zones, no femoral or acetabular subsidence greater than or equal to 5 mm from baseline, and no acetabular cup inclination changes greater than 4 degrees from baseline when accompanied by a Mild, Moderate, Marked or Disabled mHHS pain score.)

Secondary

Measure	Time frame	Description
Radiographic Findings: Number of Participants With Absence of Radiolucency	3 months, 1 year, 2 years	The number of participants identified as either Success or Failure with success defined as no radiolucencies greater than 2 millimeters (mm) in 50% or more in any of the cup or stem zones when accompanied by a Mild, Moderate, Marked or Disabled pain modified Harris Hip Score (mHHS).
Radiographic Findings: Number of Participants With Absence of Femoral Subsidence or Acetabular Migration	3 months, 1 year, 2 years	The number of participants identified as either Success or Failure with success defined as no femoral subsidence or acetabular migration greater than or equal to 5 millimeters (mm) from baseline when accompanied by a Mild, Moderate, Marked or Disabled pain modified Harris Hip Score (mHHS).
Radiographic Findings: Number of Participants With Absence of Acetabular Cup Inclination Changes	3 months, 1 year, and 2 years	Number of participants identified as Success or Failure with success defined as no acetabular cup inclination changes greater than 4 degrees from baseline when accompanied by a Mild, Moderate, Marked or Disabled pain modified Harris Hip Score (mHHS).
Implant Survivorship Kaplan-Meier Estimate	Postoperatively, up to 3 years	The Kaplan-Meier estimate of implant survivorship was measured from date of surgery to date of final visit with survival defined as no revision for any reason. A revision indicated reoperation was needed where any component (acetabular cup, acetabular liner, femoral head, or femoral stem) was replaced.
Modified Hip Harris Score (mHHS)	Preoperative, 3 months, 1 year, 2 years, 3 years	The Harris Hip Score (HHS) is a joint specific score that consists of 10 items covering domains of pain, function, functional activities, absence of deformity, and hip range of motion. The modified Harris Hip Score (mHHS) includes all the same domains as the HHS except for the hip range of motion. Total mHHS scale ranges from 0 (worst) to 95 (best).

Countries

United States

Participant flow

Recruitment details

Overall, 232 participants were screened with 189 participants enrolled to the study at 10 sites; however, 3 sites were terminated early due to lack of enrollment.

Participants by arm

Arm	Count
R3™ Biolox® Delta Ceramic Acetabular System Participants that underwent primary total hip arthroplasty with the R3™ Biolox® delta Ceramic Acetabular System	189
Total	189

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Adverse Event	1
Overall Study	Death	4
Overall Study	Investigator judgment	1
Overall Study	Lost to Follow-up	37
Overall Study	Participant not able to return	6
Overall Study	Participant withdrew consent	8
Overall Study	Screen fail due to femoral stem implanted not being allowed per protocol	1

Baseline characteristics

Characteristic	R3™ Biolox® Delta Ceramic Acetabular System
Age, Continuous	58.60 years STANDARD_DEVIATION 12.75
Age, Customized Age Group < 65	112 Participants
Age, Customized Age Group >= 65	77 Participants
Body Mass Index (BMI)	29.00 kg/m^2 STANDARD_DEVIATION 5.01
Operative Side Left	88 Participants
Operative Side Right	101 Participants
Race/Ethnicity, Customized Race Asian	3 Participants
Race/Ethnicity, Customized Race Black	37 Participants
Race/Ethnicity, Customized Race Other	3 Participants
Race/Ethnicity, Customized Race White	146 Participants
Region of Enrollment United States	189 participants
Sex: Female, Male Female	110 Participants
Sex: Female, Male Male	79 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	4 / 189
other Total, other adverse events	101 / 189
serious Total, serious adverse events	70 / 189

Outcome results

Primary

Component Revisions at 3 Years Postoperative

Number of participants component revisions identified as Success or Failure with success defined as no component revision for any reason.

Time frame: 3 Years Postoperative