H1 Hip Resurfacing Arthroplasty
Research type
Research Study
Full title
A Prospective, Non-randomized, Consecutive Series, Multicentre, Observational Study to Evaluate the Clinical Outcome of Ceramic-on-Ceramic Hip Resurfacing Arthroplasty Using the H1 hip joint ceramic non-porous non-cemented prosthesis.
IRAS ID
213102
Contact name
Justin Cobb
Contact email
Sponsor organisation
Embody Orthopaedic Limited
Duration of Study in the UK
11 years, 0 months, 1 days
Research summary
This study will document the safety and efficacy of a novel ceramic-on-ceramic hip resurfacing prosthesis, called H1, as a treatment of end-stage hip osteoarthritis. When performing a hip resurfacing, the surgeon only removes the diseased cartilage of the hip joint and replaces it with a prosthesis that re-covers the articular surfaces in the pelvis and on the head of the thigh bone. The primary goal of this study is to confirm the safety and efficacy of the H1 hip resurfacing prosthesis by demonstrating it performs as well as the Birmingham Hip Resurfacing which has a track record of very good results at more than 10 years. The secondary goal is to demonstrate superiority of the H1 ceramic hip resurfacing compared to metal-on-metal hip resurfacing as there is no metal ion release. We expect the ceramic hip resurfacing to allow for a better function and higher activity levels than conventional total hip replacement where a metal stem is placed into the medullary canal of the thigh bone.
The study will be subdivided in a short-term safety study in 20 patients which aims at recording and analysing any early postoperative complications possibly associated with the new device, such as loosening of the prosthesis. Besides, blood will be drawn to confirm the absence of metal ions. At 3months, 6months, 1 & 2years postoperatively, the occurrence of early complications will be compared with internationally accepted risk rates after total hip replacement. If as expected, safety is confirmed, the following efficacy study will evaluate the clinical results (pain relief, function, activity, quality of life and satisfaction) and survivorship of the H1 hip resurfacing at 6 months, 1, 2, 3, 5 and 7 years, whilst a final analysis is planned at 10 years. In total 250 patients will be enrolled in 2 UK and 3 international sites.REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
17/EE/0330
Date of REC Opinion
12 Sep 2017
REC opinion
Further Information Favourable Opinion