Comprehensive Segmental Revision System
Study Details
Study Description
Brief Summary
Clinical Data evaluation to document the performance and clinical outcomes of the Comprehensive Segmental Revision System.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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 five (5) years from the time of surgery.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Comprehensive SRS Replacement Comprehensive SRS Device |
Device: Comprehensive SRS Replacement
This system consist of a proximal humeral replacement, distal humeral replacement, or total humeral replacement.
|
Outcome Measures
Primary Outcome Measures
- Implant survivorship assessed according to the implant revisions [10 years]
Implant survivorship assessed counting the number of implant revisions
Secondary Outcome Measures
- 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.
- 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: 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: 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.
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Non Inflammatory Degenerative joint disease, including osteoarthritis, and avascular necrosis
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Rheumatoid arthritis
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Revision where other devices or treatments have failed
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Correction of functional deformity
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Oncology applications including bone loss due to tumour resection
Exclusion Criteria:
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Sepsis ( active)
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Infection ( active)
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Osteomyelitis (active)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Nova Scotia Health Authority | Halifax | Nova Scotia | Canada | B3H-1796 |
| 2 | Department of Orthopedic Surgery, Rigshospitalet University of Copenhagen | Copenhagen | Denmark | ||
| 3 | Royal Gwent Hospital | Newport | Wales | United Kingdom | NP20 2UB |
| 4 | University of Liverpool | Liverpool | United Kingdom |
Sponsors and Collaborators
- Zimmer Biomet
Investigators
- Study Chair: Oliver Schaetti, PhD, Zimmer Biomet, Jr. Clinical Project Lead
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ORTHO.CR.GE5