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

October 21, 2019 updated by: Istituto Ortopedico Rizzoli

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Actual)

68

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bologna, Italy, 40136
        • IRCSS Istituto Ortopedico Rizzoli

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

retrospective, consecutive population treated with a cementless total hip arthroplasty with ceramic-on-ceramic bearing surfaces for post-traumatic hip osteoarthritis due to acetabular fracture. A minimum follow-up of 10 years was mandatory.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival Rates of the Hip Implants
Time Frame: 10 years-18 years
Kaplan Meier curve with 95% confidence intervals
10 years-18 years
Clinical Outcomes of the Hip Implants
Time Frame: 10 years-18 years
HHS score (Harris Hip Score). Total scale: 0-100. Best performance: 100
10 years-18 years
Clinical Outcomes of the Hip Implants
Time Frame: 10 years -18 years
WOMAC score (Western Ontario and McMaster Universities Osteoarthritis Index). Total scale: 0-96. Best performance: 96
10 years -18 years
Percentage of Patients With Adequate Radiographic Cup Osseointegration
Time Frame: 10 years-18 years
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
10 years-18 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Ortopedico Rizzoli

Investigators

  • Study Chair: Francesco Traina, MD, IRCCS Istituto Ortopedico Rizzoli

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 15, 2019

Primary Completion (ACTUAL)

July 19, 2019

Study Completion (ACTUAL)

August 20, 2019

Study Registration Dates

First Submitted

July 16, 2019

First Submitted That Met QC Criteria

July 24, 2019

First Posted (ACTUAL)

July 26, 2019

Study Record Updates

Last Update Posted (ACTUAL)

November 12, 2019

Last Update Submitted That Met QC Criteria

October 21, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 383/2019/OSS/IOR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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