Background: Advantages of hip resurfacing arthroplasty over total hip arthroplasty include the preservation of the thigh bone, reduction in the risk of dislocation due to the large size of the ball, revision surgery being easier, and higher activity level in younger participants. However, metal-on-metal hip resurfacings has been shown to cause higher metal ion levels and some participants reported progressive pain leading to early revision. By exchanging the metal material of the bearing with BIOLOX®delta ceramic, the main cause of early revision is removed. The H1 Implant is innovative both in its anatomical shape and in its materials as there is currently no all-ceramic, completely cementless hip resurfacing implant in clinical use.
Methods: This is a multicentre, prospective, non-randomized, observational study to evaluate the clinical outcome of the H1 System, which consists of the H1 Implant and the H1 Instruments. The intended application of the H1 Implant is to replace the diseased areas of the articular surface and restore joint function. The aim is to recruit 250 participants. Adult participants up to the age of 70 years will be recruited and followed-up for 10 years from the date of surgery. All operative complications, both intraoperative and postoperative through discharge will be collected. Any complication, whether device-related, surgery related or otherwise, will be collected and reported where applicable. The assessment of the safety and performance characteristics as well as establish the superiority of the ceramic-on-ceramic bearing couple of the H1 Implant will be evaluated and compared to metal-on-metal hip resurfacings in the literature.
Discussion: This study protocol describes the H1 Clinical Investigation. The protocol was designed by clinicians, experienced trialists and patients, in order to test the safety and performance of The H1 System.
Trial registration: ISRCTN registry with study ID ISRCTN91554748