MASTER SL clinical study
Research type
Research Study
Full title
A prospective, observational, multi-centre, cohort study of the MASTER SL femoral stem and DELTA TT acetabular cup in patients with degenerative disease of the hip.
IRAS ID
133133
Contact name
Robert Middleton
Contact email
Research summary
The hip joint has a 'ball and socket' configuration. The ball is represented by the head of the femur (thigh bone) and the socket by the acetabulum (concave surface of the pelvis), both articulate together in order to produce movement in an infinite number of planes. The most common disease to affect the hip is Osteoarthritis.
Osteoarthritis presents with pain and reduced function in the affected joint. Treatment can be operative or non-operative, but this would depend on the severity of symptoms, physical examinations and radiological assessments.
Non-operative treatments consist of: rest, weight loss, pain relief medications and physiotherapy. Severe disease will typically require replacement of the joint with a suitable prosthetic device consisting of a cup fitted into the acetabulum and a new head with stem fitted into the upper shaft of the femur, this is known as a Total Hip Replacement (THR), but is sometimes called Total Hip Arthroplasty (THA).
Due to remarkable and continuous improvements in surgical techniques, biomaterials and implant design, Total Hip Replacement is an extremely successful operation. However, the 'perfect' prosthesis has yet to be designed and so it is necessary to continually evaluate new advances in the design of hip replacement components so that continued improvements are sought to enhance the longevity of hip replacements and improve patient outcomes.
The two major factors that influence the survivorship or longevity of total hip replacement prosthesis are fixation of the hip replacement components and wear of the bearing surfaces. The design and materials used in the manufacture of hip replacement components has an impact on these factors.
Principal Investigators involved in this study will be trained orthopaedic surgeons who have expertise in treating Osteoarthritis of the hip. Inclusion and Exclusion criteria will be strictly defined in order to ensure only suitable patients are invited to participate, to reduce any potential risks associated with the study.
Once Ethics Committee Approval has been obtained, the study may commence. Investigators may assess patients' medical history to determine their suitability and eligibility for participation in the study. Participation in the study will be discussed with suitable patients, where the Investigator will discuss the duration of the study, potential benefits and risks, duration of follow-up, study requirements and conditions of the study. Patients will be informed that participation in the study is optional, and that if they do agree to participate they are free to withdraw from the study at any time. Patients will be aware that their medical records will be accessed by the Sponsor or their representatives, regulatory authorities or by the hospital at which they were recruited.
Patients will be given adequate time to consider their participation in the study, to discuss with family and/or friends and the opportunity to ask any questions before they make a decision.
REC name
London - Dulwich Research Ethics Committee
REC reference
14/LO/0052
Date of REC Opinion
14 Mar 2014
REC opinion
Further Information Favourable Opinion