Comprehensive Segmental Revision System

Zimmer Biomet

Status: Active, not recruiting

Conditions: Degenerative Disease; Revision Surgery; Oncology; Trauma; Rheumatoid Arthritis

Treatments: Device: Comprehensive SRS Replacement

Study type: Observational

Funder types: Industry

Identifiers

NCT03270982

ORTHO.CR.GE5

Details and patient eligibility

About

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

Full 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.

Enrollment: 105 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Non Inflammatory Degenerative joint disease, including osteoarthritis, and avascular necrosis
• Rheumatoid arthritis
• Revision where other devices or treatments have failed
• Correction of functional deformity
• Oncology applications including bone loss due to tumour resection

Exclusion criteria

• Sepsis ( active)
• Infection ( active)
• Osteomyelitis (active)

Trial design

105 participants in 1 patient group

Comprehensive SRS Replacement

Description:

Comprehensive SRS Device

Treatment:

Device: Comprehensive SRS Replacement