Zimmer Biomet
Clinical Data evaluation to document the performance and clinical outcomes of the Comprehensive Segmental Revision System.
Degenerative Disease
Oncology
Revision Surgery
Trauma
Rheumatoid Arthritis
Comprehensive SRS Replacement
The Purpose of this multi centre clinical data evaluation is to document the performance and clinical outcomes of the Comprehensive Segmental revision System. The data gathered will be collated and used to provide feedback to designing engineers, support marketing efforts, answer potential questions from reimbursement agencies, and will serve as part of Zimmer Biomets Post Market Surveillance. The Comprehensive Segmental Revision System consists of a proximal humeral replacement system (shoulder prosthesis), a distal humeral replacement system (elbow prosthesis) and of a total humeral replacement system (shoulder and elbow prosthesis connected by a humeral coupler). Patient outcomes will be measured by using measurement tools that have been extensively used and referred to in the literature. Specifically, the quickDASH will be used for all cases enrolled in the study. In addition, the Constant and Murley Score may be used for shoulder applications, the Liverpool Elbow Score may be used for elbow applications and the MSTS Score may be used for tumor cases. The study population will be compromised of males and females that are eligible according to the inclusion/exclusion criteria. The study will last for at least ten (10) years from the time of surgery.
| Study Type : | OBSERVATIONAL |
| Estimated Enrollment : | 105 participants |
| Official Title : | Comprehensive Segmental Revision System |
| Actual Study Start Date : | 2016-04 |
| Estimated Primary Completion Date : | 2034-12 |
| Estimated Study Completion Date : | 2034-12 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | |
| Sexes Eligible for Study: | ALL |
| Accepts Healthy Volunteers: |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
RECRUITING
Nova Scotia Health Authority
Halifax, Nova Scotia, Canada, He sold it-1796
RECRUITING
Department of Orthopedic Surgery, Rigshospitalet University of Copenhagen
Copenhagen, Denmark,
COMPLETED
Royal Gwent Hospital
Newport, Wales, United Kingdom, NP20 2UB
RECRUITING
Royal Liverpool University Hospital
Liverpool, United Kingdom,