Clinical trial NCT04034043: Ceramic-on-ceramic THA for Post-traumatic Hip Osteoarthritis After Acetabular Fracture
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hip Osteoarthritis
Post-traumatic Osteoarthritis
Keywords: ceramic-on-ceramic
total hip arthroplasty
acetabular fracture
post-traumatic hip osteoarthritis
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2019-07-26
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Survival Rates of the Hip Implants
timeFrame: 10 years-18 years
measure: Clinical Outcomes of the Hip Implants
timeFrame: 10 years-18 years
measure: Clinical Outcomes of the Hip Implants
timeFrame: 10 years -18 years
measure: Percentage of Patients With Adequate Radiographic Cup Osseointegration
timeFrame: 10 years-18 years
Secondary outcomes:
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCSS Istituto Ortopedico Rizzoli
Study officials:
affiliation: IRCCS Istituto Ortopedico Rizzoli
name: Francesco Traina, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.