Comprehensive Segmental Revision System

Rheumatoid Arthritis Clinical Trial

Official title:

Comprehensive Segmental Revision System

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03270982
• Other study ID #: ORTHO.CR.GE5
• Status: Recruiting
• Start date: April 2016
• Est. completion date: December 2034

Study information

• Verified date: March 2024
• Source: Zimmer Biomet
• Contact: Carina Hafner
• Phone: +41 79 707 30 93
• Email: carina.hafner[@]zimmerbiomet.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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 information / eligibility

• Status: Recruiting
• Enrollment: 105
• Est. completion date: December 2034
• Est. primary completion date: December 2034
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

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

Intervention

Device:
• Comprehensive SRS Replacement
This system consist of a proximal humeral replacement, distal humeral replacement, or total humeral replacement.

Locations

Country	Name	City	State
Canada	Nova Scotia Health Authority	Halifax	Nova Scotia
Denmark	Department of Orthopedic Surgery, Rigshospitalet University of Copenhagen	Copenhagen
United Kingdom	Royal Liverpool University Hospital	Liverpool
United Kingdom	Royal Gwent Hospital	Newport	Wales

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Countries where clinical trial is conducted

Canada,  Denmark,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Implant survivorship assessed according to the implant revisions	Implant survivorship assessed counting the number of implant revisions	10 years
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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