None listed
Conditions
Brief summary
Factors for operative treatment include severity of diseases that affect the hip, symptoms, clinical finding on physical examination and radiological assessment of the hip. When referring to total hip replacement (THR) surgery, both the acetabular socket and the head of the femur are replaced with a suitable prosthetic device consisting of a cup fitted into the acetabulum (socket) and a new head (ball) with stem fitted into the upper shaft of the femur. Two major factors influence the outcome of THR (outside the surgery process itself) and these are the fixation of the components to the bone and wear of the implanted surfaces. (between the ball and socket). THR is an extremely successful operation due to continuous improvements in surgical techniques, bio-materials and implant design. It is necessary however, to safely evaluate new advances in the design of hip replacement components so that improvements are sought to continually enhance patient outcomes. The design and materials used in the MASTER-SL femoral implant are very similar to other prosthesis already used by surgeons. The aim of this trial is to assess the clinical performance of the MASTER-SL femoral stem over a two year period under standard condition of use in THR.
Interventions
Sponsors
Eligibility
Inclusion criteria
Male and female >18 years; radiologically confirmed diagnosis of primary osteoarthritis (OS) of the hip and suitable for primary total hip replacement; Life expectancy of > 10 years Receiving a MASTER-SL femoral stem Voluntary written informed consent obtained
Exclusion criteria
Prospect for recovery to independent mobility compromised by known coexistent, medical problems; Requiring revision hip replacement; Loss of abductor musculature, poor bone stock, or poor skin coverage around the hip join; Previous organ transplant; Previous hip replacement (resurfacing or THR) on the contra-lateral side within the last 6 months; Previous hip replacement (resurfacing or THR) on the contralateral side and whose outcome is achieving an Oxford Hip score <18 points; Body mass index > 40 kg/m2 Active or suspected infection; Known sensitivity to device materials; Pregnant woman