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

Hip Osteoarthritis Clinical Trial

— APT  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04034043
• Other study ID #: 383/2019/OSS/IOR
• Status: Completed
• Start date: July 15, 2019
• Est. completion date: August 20, 2019

Study information

• Verified date: July 2019
• Source: Istituto Ortopedico Rizzoli
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: August 20, 2019
• Est. primary completion date: July 19, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hip Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Hip
• Post-traumatic Osteoarthritis

Intervention

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

Locations

Country	Name	City	State
Italy	IRCSS Istituto Ortopedico Rizzoli	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Ortopedico Rizzoli

Country where clinical trial is conducted

Italy, 

References & Publications (6)

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. — View Citation

Berry DJ. Total hip arthroplasty following acetabular fracture. Orthopedics. 1999 Sep;22(9):837-9. Review. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival Rates of the Hip Implants	Kaplan Meier curve with 95% confidence intervals	10 years-18 years
Primary	Clinical Outcomes of the Hip Implants	HHS score (Harris Hip Score). Total scale: 0-100. Best performance: 100	10 years-18 years
Primary	Clinical Outcomes of the Hip Implants	WOMAC score (Western Ontario and McMaster Universities Osteoarthritis Index). Total scale: 0-96. Best performance: 96	10 years -18 years
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	10 years-18 years