Post-market clinical follow-up study of the MobileLink Hip cup system
Research type
Research Study
Full title
Clinical and functional outcome of the MobileLink acetabular cup system in the short-, mid- and long-term follow-up
IRAS ID
293126
Contact name
Muhammad Adeel Akhtar
Contact email
Sponsor organisation
Waldemar Link GmbH & Co. KG
Clinicaltrials.gov Identifier
Duration of Study in the UK
12 years, 3 months, 1 days
Research summary
The newly developed MobileLink acetabular cup system is used in total hip arthroplasty and intended for a long-term replacement of a diseased and / or defective acetabulum. According to the current knowledge the MobileLink acetabular cup system is state of the art and its benefit / risk profile is acceptable. However, currently no clinical data is available for the MobileLink acetabular cup system itself. With this prospective, multi-center, open-label case series study its safety and performance under real world conditions shall be confirmed to identify previously unknown and to monitor already identified side effects in the short-, mid- and long-term follow-up. To measure the performance, the 3 month, 1, 3, 5, 7 and 10-year survival rates of the complete MobileLink acetabular cup system and the different components are used as endpoints. In addition, the patient reported outcome, occurred complications and re-operations of the hip joint, the radiological outcome and the handling with the surgical instruments is requested. All adult patients who undergo a total hip arthroplasty (THA) with usage of a MobileLink acetabular cup system shall be potentially included. The decision to implant a MobileLink acetabular cup system is made by the treating surgeon independently from the study. Data on the preoperative visit, the surgery itself and the discharge is collected. Additionally, the patients need to visit the study site at the mentioned follow-up time points, answer a short interview and one questionnaires. In total 520 patients (at four study sites in Germany and Scotland) shall be recruited within a maximum recruiting period of two years.
REC name
East Midlands - Nottingham 1 Research Ethics Committee
REC reference
21/EM/0122
Date of REC Opinion
21 May 2021
REC opinion
Further Information Favourable Opinion