Comprehensive Segmental Revision System

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

Detailed Description
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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.

Official Title
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Comprehensive Segmental Revision System

Conditions
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Trauma, Degenerative Disease, Oncology, Revision Surgery, Rheumatoid Arthritis

Intervention / Treatment
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* Device: Comprehensive SRS Replacement


Participation Criteria
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Eligibility Criteria
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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)
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Comprehensive SRS Replacement<br>Comprehensive SRS Device | Device: Comprehensive SRS Replacement<br>* This system consist of a proximal humeral replacement, distal humeral replacement, or total humeral replacement.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implant survivorship assessed according to the implant revisions | Implant survivorship assessed counting the number of implant revisions | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical patient outcome measure: QuickDASH | 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. | Pre-operative and at 6 months, 1 year, 3 years and 5 years post-operative | 
| Clinical patient outcome measure: Constant-Murley Score | 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. | Pre-operative and at 6 months, 1 year, 3 years and 5 years post-operative | 
| Clinical patient outcome measure: Liverpool Elbow Score | 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. | Pre-operative and at 6 months, 1 year, 3 years and 5 years post-operative | 
| Clinical patient outcome measure: Musculoskeletal Tumour Society Scoring System (MSTS) | 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. | 6 months, 1 year, 3 years and 5 years post-operative | 
| Safety is assessed according to the number of complications | Safety is assessed according to the number of complications which are collected via adverse event forms | 10 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non Inflammatory Degenerative Joint Disease, Rheumatoid Arthritis, Revision where other devices have failed, Correction of functional deformity, Oncology Applications, Treatment of acute or Chronic fractures