Monitoring of metal-backed glenoid components using RSA
Research type
Research Study
Full title
Radiostereometric analysis of the stability of metal-backed glenoid components in total shoulder arthroplasty
IRAS ID
121545
Contact name
Ian Trail
Contact email
Research summary
Two variations of a metal back shoulder replacement component have been developed by Lima for use either in the United States or in other parts of the world. The US version has a slightly different metal substrate. The rest of the world component is also coated with hydroxyapatite. At this time there is no available clinical evidence that either of these is more effective, in terms of clinical outcome and the survivorship of the component, compared to older designs. Patients who are listed for total shoulder replacement at Wrightington Hospital will be approached to take part in this study. The joint replacement and the surgery itself will be undertaken in a standard fashion identical to patients who are not part of the study. An additional procedure will be the insertion of tantalum balls, in and around the glenoid. During the recovery phase and at follow-up clinics, specialist X-rays will be taken and analysed using a refined computer system. The technique involved in this procedure is well established and is able to identify any potential movement of the implant at an early stage. CT scans will also be taken before and after surgery in order to obtain more reliable data than with plain x-rays. In addition, participants will be asked to complete questionnaires which are a self-assessed evaluation of levels of pain and ease of performing daily activities. A physiotherapist will also conduct a standard clinical evaluation of the shoulder.
REC name
North West - Preston Research Ethics Committee
REC reference
13/NW/0357
Date of REC Opinion
4 Jul 2013
REC opinion
Further Information Favourable Opinion