NCT03270982

Comprehensive Segmental Revision System

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 105 (estimated)
• Sponsor: Zimmer Biomet · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

Clinical Data evaluation to document the performance and clinical outcomes of the Comprehensive Segmental Revision System.

Detailed description

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.

Conditions

• Degenerative Disease
• Oncology
• Revision Surgery
• Trauma
• Rheumatoid Arthritis

Interventions

Type	Name	Description
DEVICE	Comprehensive SRS Replacement	This system consist of a proximal humeral replacement, distal humeral replacement, or total humeral replacement.

Timeline

• Start date: 2016-04-01
• Primary completion: 2035-12-01
• Completion: 2035-12-01
• First posted: 2017-09-01
• Last updated: 2025-12-23

Locations

4 sites across 3 countries: Canada, Denmark, United Kingdom

Regulatory

• FDA-regulated device study