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Hip OsteoarthritisAPTNCT04034043

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

An observational study of Hip Osteoarthritis and Post-traumatic Osteoarthritis, run by Istituto Ortopedico Rizzoli at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
ceramic-on-ceramic total hip arthroplasty
Type of treatment
Medical device
How many people
68 participants
Where
1 siteItaly
Study dates
15 Jul 2019to 20 Aug 2019
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • IRCSS Istituto Ortopedico Rizzoli

    Bologna, 40136

Other trials in Italy

About this study

Official title: 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.

Read the 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

Being tested
ceramic-on-ceramic total hip arthroplasty
Keywords
ceramic-on-ceramic, total hip arthroplasty, acetabular fracture, post-traumatic hip osteoarthritis
Medical subject headings
Osteoarthritis, Hip

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ceramic-on-ceramic total hip arthroplastyDevice

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Survival Rates of the Hip Implants

    Kaplan Meier curve with 95% confidence intervals

    Measured: 10 years-18 years

  2. Clinical Outcomes of the Hip Implants

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

    Measured: 10 years-18 years

  3. Clinical Outcomes of the Hip Implants

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

    Measured: 10 years -18 years

  4. 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

    Measured: 10 years-18 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jul 2019
  2. Study start15 Jul 2019
  3. Primary completion19 Jul 2019
  4. Study completion20 Aug 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
68 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04034043
Sponsor's protocol ID
383/2019/OSS/IOR
Acronym
APT
Status last verified
Jul 2019
First submitted
16 Jul 2019
Last updated
12 Nov 2019
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 11407795

  • 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.

    PubMed 25034883

  • 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.

    PubMed 9759814

  • 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.

    PubMed 10507340

  • 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.

    PubMed 18534534

  • 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.

    PubMed 21474274

Questions about this trial

What is this clinical trial studying?

An observational study of Hip Osteoarthritis and Post-traumatic Osteoarthritis, run by Istituto Ortopedico Rizzoli at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Survival Rates of the Hip Implants (time frame: 10 years-18 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04034043, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2019.

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