Anatomical Shoulder Domelock System study
Research type
Research Study
Full title
Anatomical Shoulder Domelock system A Multicentre, Prospective, Non-controlled Post-Market Clinical Follow-up Study
IRAS ID
229399
Contact name
Paolo Rusconi
Contact email
Clinicaltrials.gov Identifier
Duration of Study in the UK
12 years, 0 months, 1 days
Research summary
This study is a multicenter, prospective, non-controlled post-marked clinical follow-up study involving orthopaedic surgeons skilled in hemi and total shoulder arthroplasty procedures. In total, there will be a minimum of five study centers, and the Royal Derby Hospital is the only participating site in the UK. The objectives of this study are to confirm safety and performance of the Anatomical Shoulder Domelock System by analysis of standard scoring systems, radiographs and adverse event records. Each Investigator will offer study participation to each consecutive eligible patient. All patients will need to sign the informed consent form and satisfy the Inclusion/Exclusion criteria of this study. Following completion of the informed consent process, participants will undergo preoperative clinical evaluations prior to their shoulder surgery. Patients will then be asked to attend post-operative follow-up clinic visits at 3 -6 months, 1 year, 2 year, 3 year, 5 year, 7 year and 10 year. At these follow-up visits, clinical and radiographic evaluations will be conducted (Radiographs for 3 and 7 year visits will only be taken if medically indicated).
REC name
South West - Frenchay Research Ethics Committee
REC reference
18/SW/0091
Date of REC Opinion
4 Jun 2018
REC opinion
Further Information Favourable Opinion