H1 Hip Resurfacing Arthroplasty

Investigation type: Premarket study to receive a CE marking, followed by post-marketing surveillance follow-up.

Investigation design: Multi-centre, prospective, non-randomized, observational study

Investigation objectives:

The primary objective is to confirm the safety and efficacy of the H1 hip resurfacing prosthesis by demonstrating non-inferiority of the cumulative percent success in subjects implanted with the H1 hip resurfacing compared to a literature reference rate of the Birmingham hip resurfacing (BHR).

The secondary objective is to demonstrate superiority of the ceramic-on-ceramic H1 hip resurfacing prosthesis with its metal-free articulation compared to MoM hip resurfacing in the absence of metal ion release. Additional goals are to demonstrate non-inferiority of the ceramic-on-ceramic H1 hip resurfacing prosthesis compared to hip resurfacing with regard to patient reported outcome measures, objective clinical and functional outcomes, and radiological assessment.

The primary endpoint is revision for any reason

Secondary endpoints:

* Complication rate (adverse events and revisions) * Toxicology (blood metal ion measurements) * CT assessment (Implant migration) * Patient Reported Outcome Measures (PROMs) * Objective clinical and functional outcomes (Harris Hip Score, Gait Analysis) * Radiological assessment (implant orientation, osseointegration)

Background Information

Total Hip Arthroplasty (THA) is one of the most successful surgical interventions. Replacement of an arthritic hip joint provides significant pain relief and improvement of hip function and mobility. Patients, even elderly people, are more active, have a better quality of life, less comorbidities and a longer life expectancy. The World Health Organisation (WHO) has declared THA the second best intervention, only preceded by cataract surgery, regarding cost effectiveness and quality of outcome. In patients older than 70 years, the overall survivorship of THA is more than 90% at 10 years and the best clinical results are obtained for THA as a treatment for osteoarthritis (OA). In this patient population, THA can thus be considered a lifelong solution. However, both survivorship and clinical results are much worse in young and active people. The reasons for this worse outcome are multiple. First of all, younger people usually have a more active lifestyle regarding work and sports. Secondly, the hip disorders leading to THA in a younger patient population are more difficult to treat. Congenital hip dysplasia is frequently associated with gross hip deformities, as may be the case in secondary traumatic OA. Bone stock may be jeopardised in cases of avascular necrosis of the femoral head (AVN) and rheumatoid arthritis (RA). Thirdly, a faster bone metabolism may play a role, but this remains to be elucidated.