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Ceramic-on-ceramic THA for Post-traumatic Hip Osteoarthritis After Acetabular Fracture

Retrospective Study About Cementless Total Hip Arthroplasty With Ceramic-on-ceramic Bearing Surfaces for Post-traumatic Hip Osteoarthritis After Acetabular Fracture: Long-term Results (ATP)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04034043
Acronym
APT
Enrollment
68
Registered
2019-07-26
Start date
2019-07-15
Completion date
2019-08-20
Last updated
2019-11-12

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

Conditions

Hip Osteoarthritis, Post-traumatic Osteoarthritis

Keywords

ceramic-on-ceramic, total hip arthroplasty, acetabular fracture, post-traumatic hip osteoarthritis

Brief summary

A retrospective consecutive population of patients treated with cementless total hip arthroplasty with ceramic-on-ceramic bearing surfaces due to post-traumatic osteoarthritis due to acetabular fractures will be selected. The aim of this retrospective study is to evaluate the long-term clinical and radiographic results of this implant in such a specific cohort. The secondary aim of the sudy is to provide the complication rate and the failure rate of the cohort. A descriptive analysis of the failures will be provided as well.

Detailed description

Total hip arthroplasty (THA) is the recommended treatment to restore functionality and control pain in post-traumatic hip osteoarthritis due to acetabular fractures. However, THA in post-traumatic osteoarthritis following acetabular fractures is a complex procedure and it is burdened with occasional failures. Modest long-term outcomes have been reported, generally lower than conventional THAs performed due to osteonecrosis or primary osteoarthritis: 10-year clinical results are usually good but not excellent (average Harris Hip score: 88), 10-year revision rate is between 15% and 26%. In review study about the complications of post-traumatic THAs, 30% of ossifications, 4.4% of dislocations, 5.6% of infections, and 2.1% of neurovascular lesions were reported: all the percentages were higher than in primary conventional THAs. The most critical issues are related to the young age of the patients, to the anatomical changes affecting the periarticular tissues, to the presence of hardware and to the greater exposure to septic complications. All these factors may prevent the surgeon to achieve a good cup positioning and a satisfying outcome. However a correct surgical technique, associated with meticulous pre-operative planning and the use of low-wear implants can improve the clinical result and the long term survival rates. However, the literature about mid-to-long-term studies about post-traumatic THAs is scarce (currently 5 with an average follow-up of at least 5 years). Furthermore, these studies often include outdated implants, positioned with invasive surgical techniques and with removal of all previous hardware. Therefore, a long-term study (minimum 10-year follow-up) involving more recent implants, with modern articular couplings demonstrating low wear (such as ceramic-on-ceramic), and performed with minimally invasive technique and pre-operative CT-guided planning, would be desirable. The aim of this study is to describe the survival rates and the long-term clinical and radiological outcome (minimum 10-year follow-up) of cementless THAs, with ceramic-on-ceramic couplings, performed with minimally-invasive technique and CT guided pre-operative planning, in post-traumatic osteoarthritis due to acetabular fractures

Interventions

DEVICEceramic-on-ceramic total hip arthroplasty

ceramic-on-ceramic, cementless total hip arthroplasty for post-traumatic hip osteoarthritis.

Sponsors

Istituto Ortopedico Rizzoli
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* symptomatic, post-traumatic hip osteoarthritis due to acetabular fracture * consecutive population with a minimum follow-up of 10 years * cementless total hip arthroplasty with ceramic-on-ceramic bearing surfaces * pre-operative planning using CT * complete clinical and radiographic assessment

Exclusion criteria

* other type of hip osteoarthritis * other type of implants * inadequate pre-operative planning (eg: no CT) * incomplete assessment

Design outcomes

Primary

MeasureTime frameDescription
Survival Rates of the Hip Implants10 years-18 yearsKaplan Meier curve with 95% confidence intervals
Clinical Outcomes of the Hip Implants10 years-18 yearsHHS score (Harris Hip Score). Total scale: 0-100. Best performance: 100
Percentage of Patients With Adequate Radiographic Cup Osseointegration10 years-18 yearsPercentage of patients with a good osseointegration defined by the criteria described by Moore et al. Measurement technique: qualitative visual assessment of 5 binary parameters (yes/no): radial trabeculae, stress shielding, superolateral buttress, inferomedial buttress, absence of radiolucent lines. Adequate osseointegration: at least 3 parameters are present. Total scale: 0%-100%. Best performance (every patient has adequate osseointegration at 10 years): 100

Countries

Italy

Participant flow

Participants by arm

ArmCount
THA Post Acetabular Fractures
Ceramic-on-ceramic THA for Post-traumatic Hip Osteoarthritis After Acetabular Fracture with a minimum follow-up of 10 years
68
Total68

Baseline characteristics

CharacteristicTHA Post Acetabular Fractures
Age, Continuous47.6 years
STANDARD_DEVIATION 11.6
percentages of patients treated operatively50 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
0 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
68 Participants
Region of Enrollment
Italy
68 participants
Sex: Female, Male
Female
8 Participants
Sex: Female, Male
Male
60 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 68
other
Total, other adverse events
2 / 60
serious
Total, serious adverse events
8 / 68

Outcome results

Primary

Clinical Outcomes of the Hip Implants

HHS score (Harris Hip Score). Total scale: 0-100. Best performance: 100

Time frame: 10 years-18 years

ArmMeasureValue (MEAN)Dispersion
THA Post Acetabular FracturesClinical Outcomes of the Hip Implants88.4 score on a scaleStandard Deviation 11.6
Primary

Clinical Outcomes of the Hip Implants

WOMAC score (Western Ontario and McMaster Universities Osteoarthritis Index). Total scale: 0-96. Best performance: 96

Time frame: 10 years -18 years

ArmMeasureValue (MEAN)Dispersion
THA Post Acetabular FracturesClinical Outcomes of the Hip Implants84.3 score on a scaleStandard Deviation 9.6
Primary

Percentage of Patients With Adequate Radiographic Cup Osseointegration

Percentage of patients with a good osseointegration defined by the criteria described by Moore et al. Measurement technique: qualitative visual assessment of 5 binary parameters (yes/no): radial trabeculae, stress shielding, superolateral buttress, inferomedial buttress, absence of radiolucent lines. Adequate osseointegration: at least 3 parameters are present. Total scale: 0%-100%. Best performance (every patient has adequate osseointegration at 10 years): 100

Time frame: 10 years-18 years

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
THA Post Acetabular FracturesPercentage of Patients With Adequate Radiographic Cup Osseointegration68 Participants
Primary

Survival Rates of the Hip Implants

Kaplan Meier curve with 95% confidence intervals

Time frame: 10 years-18 years

ArmMeasureValue (MEAN)
THA Post Acetabular FracturesSurvival Rates of the Hip Implants96.3 percentage of non-revised implants

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