The Medacta SMS Femoral Stem Component Surveillance Study
Research type
Research Study
Full title
The Medacta SMS™ Femoral Stem Component. A Multi-National, Multi-Centre, Clinical Surveillance Study
IRAS ID
171940
Contact name
Dario Bergadano
Contact email
Duration of Study in the UK
14 years, 0 months, 1 days
Research summary
The Orthopaedic Data Evaluation Panel (ODEP) have set a benchmark standard that all hip replacements in use should have a less than 10% failure rate at 10 years. ODEP reviews new and existing orthopaedic prostheses available for purchase in the UK to ensure they have long-term safety and are cost-efficient.
The purpose of this study is to assess the clinical and radiological performance of the SMS™ femoral stem, which is a new total hip replacement component manufactured by Medacta International. This study will seek to collect ODEP-compliant data over a 10 year period on 550 patients who will receive the SMS™ stem. Data collected will include clinical and radiological data, as well as details of the surgical procedures and recorded complications over the 10-year period. This will be done in a multi-centre, prospective, two-phased study.
As this is a new, recently-CE marked device, there will be a preliminary phase (Phase 1) of the study, where the first 50 patients will be recruited. These patients will undergo an extra follow-up compared to the remainder of the study participants (Phase 2) to ensure the safety and clinical performance of the device. Once all 50 Phase 1 participants have reached their 6 month review, the investigators along with the study sponsor will perform a thorough review of the outcome scores and complications before proceeding to Phase 2. Following a favourable review with no SUSARs directly relating to the study device, the remaining 500 participants will be recruited.
Additionally, there will be a subgroup of study participants who will be invited to take part in an additional evaluation of the implant using DEXA scans. 30 participants will be recruited onto this subgroup and will receive regular DEXA scans throughout the study. These scans are used to assess fixation of the implant.
REC name
London - Bromley Research Ethics Committee
REC reference
15/LO/0507
Date of REC Opinion
30 Apr 2015
REC opinion
Further Information Favourable Opinion