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

NCT ID: NCT04034043

Last Updated: 2019-11-12

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

68 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-07-15

Study Completion Date

2019-08-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hip Osteoarthritis Post-traumatic Osteoarthritis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ceramic-on-ceramic total hip arthroplasty

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Istituto Ortopedico Rizzoli

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Francesco Traina, MD

Role: STUDY_CHAIR

IRCCS Istituto Ortopedico Rizzoli

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

IRCSS Istituto Ortopedico Rizzoli

Bologna, , Italy

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Italy

References

Explore related publications, articles, or registry entries linked to this study.

Bellabarba C, Berger RA, Bentley CD, Quigley LR, Jacobs JJ, Rosenberg AG, Sheinkop MB, Galante JO. Cementless acetabular reconstruction after acetabular fracture. J Bone Joint Surg Am. 2001 Jun;83(6):868-76. doi: 10.2106/00004623-200106000-00008.

Reference Type RESULT
PMID: 11407795 (View on PubMed)

Makridis KG, Obakponovwe O, Bobak P, Giannoudis PV. Total hip arthroplasty after acetabular fracture: incidence of complications, reoperation rates and functional outcomes: evidence today. J Arthroplasty. 2014 Oct;29(10):1983-90. doi: 10.1016/j.arth.2014.06.001. Epub 2014 Jun 12.

Reference Type RESULT
PMID: 25034883 (View on PubMed)

Weber M, Berry DJ, Harmsen WS. Total hip arthroplasty after operative treatment of an acetabular fracture. J Bone Joint Surg Am. 1998 Sep;80(9):1295-305. doi: 10.2106/00004623-199809000-00008.

Reference Type RESULT
PMID: 9759814 (View on PubMed)

Berry DJ. Total hip arthroplasty following acetabular fracture. Orthopedics. 1999 Sep;22(9):837-9. doi: 10.3928/0147-7447-19990901-14. No abstract available.

Reference Type RESULT
PMID: 10507340 (View on PubMed)

Ranawat A, Zelken J, Helfet D, Buly R. Total hip arthroplasty for posttraumatic arthritis after acetabular fracture. J Arthroplasty. 2009 Aug;24(5):759-67. doi: 10.1016/j.arth.2008.04.004. Epub 2008 Jun 4.

Reference Type RESULT
PMID: 18534534 (View on PubMed)

Lai O, Yang J, Shen B, Zhou Z, Kang P, Pei F. Midterm results of uncemented acetabular reconstruction for posttraumatic arthritis secondary to acetabular fracture. J Arthroplasty. 2011 Oct;26(7):1008-13. doi: 10.1016/j.arth.2011.02.026. Epub 2011 Apr 6.

Reference Type RESULT
PMID: 21474274 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

383/2019/OSS/IOR

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Exception Cementless Hip Stem
NCT04349046 ACTIVE_NOT_RECRUITING
Avenir® Cemented Hip Stem - PMCF
NCT03396224 ACTIVE_NOT_RECRUITING
CoMplete™ Acetabular Hip System
NCT01543230 TERMINATED NA