Cuff-tear Arthropathy Clinical Trial
Official title:
Anatomical Shoulder™ Inverse/Reverse Post-Market Surveillance Study
The purpose of this study is to obtain outcomes data on the Anatomical Shoulder™ Inverse/Reverse System by analysis of standard scoring systems and radiographs. Outcome data will be collected using the following standard scoring systems of which summary statistics will be provided: - Constant and Murley Score to evaluate clinical parameters such as range of motion, power, level of pain and functional ability. - SF-12 Physical and Mental Health Summary Measures (SF12 Questionnaire) comprising of twelve questions to assess the subject's physical and mental health status which must be answered by the patient.
This is a multi-centre, non-comparative, prospective post-market surveillance study involving orthopaedic surgeons skilled in shoulder replacement surgery. Each case enrolled will receive an Anatomical Shoulder™ Inverse/Reverse implant. All system components are CE-marked and commercially available. Patients will be selected according to the subject selection criteria. All patients will undergo pre-operative, intra-operative and post-operative physical examination, radiographic evaluation according to the hospital's routine procedure and collection of quality of life metrics. Follow-up evaluations are to be conducted at either 6 weeks or 6 months (according to the hospital's standard care plan) and thereafter at 1, 2, 5 and 10 years post hospital discharge. There are 5 study centres taking part in this project enrolling in total a maximum of 160 patients. ;