Comprehensive Segmental Revision System
- Conditions
- Revision SurgeryTraumaOncologyDegenerative DiseaseRheumatoid Arthritis
- Interventions
- Device: Comprehensive SRS Replacement
- Registration Number
- NCT03270982
- Lead Sponsor
- Zimmer Biomet
- Brief 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 105
- 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
- Sepsis ( active)
- Infection ( active)
- Osteomyelitis (active)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Comprehensive SRS Replacement Comprehensive SRS Replacement Comprehensive SRS Device
- Primary Outcome Measures
Name Time Method Implant survivorship assessed according to the implant revisions 10 years Implant survivorship assessed counting the number of implant revisions
- Secondary Outcome Measures
Name Time Method Clinical patient outcome measure: Constant-Murley Score Pre-operative and at 6 months, 1 year, 3 years and 5 years post-operative The Constant-Murley score may be used to define the level of pain and the ability to carry out the normal daily activities in patients to be treated/treated with the Comprehensive SRS products. The score consists of objective (ROM, strength) and subjective (pain, functional assessment) variables.
Clinical patient outcome measure: Musculoskeletal Tumour Society Scoring System (MSTS) 6 months, 1 year, 3 years and 5 years post-operative The MSTS Score may be used as a functional measure for patients with sarcoma involving the upper limb. The score includes 6 measures (pain, function, emotional acceptance, hand position, manual dexterity, lifting ability) each measure with a maximum of 5 points. The maximum overall score is 30 points. The score is designed to be used after the procedure and is therefore only collected post-operatively.
Clinical patient outcome measure: Liverpool Elbow Score Pre-operative and at 6 months, 1 year, 3 years and 5 years post-operative The Liverpool Elbow Score may be used to define elbow condition, function and pain in patients to be treated/treated with the Comprehensive SRS products.The score consists of two components: one patient-rated part and another part that can be measured objectively.
Clinical patient outcome measure: QuickDASH Pre-operative and at 6 months, 1 year, 3 years and 5 years post-operative The QuickDASH score will be used to measure physical function and symptoms of the upper limb in patients to be treated/treated with the Comprehensive SRS products.
Safety is assessed according to the number of complications 10 years Safety is assessed according to the number of complications which are collected via adverse event forms
Trial Locations
- Locations (4)
Nova Scotia Health Authority
🇨🇦Halifax, Nova Scotia, Canada
Department of Orthopedic Surgery, Rigshospitalet University of Copenhagen
🇩🇰Copenhagen, Denmark
Royal Gwent Hospital
🇬🇧Newport, Wales, United Kingdom
Royal Liverpool University Hospital
🇬🇧Liverpool, United Kingdom