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Active, Not Recruiting

NCT Number: NCT03270982

Comprehensive Segmental Revision System

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Degenerative Disease Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Neoplasms Oncology Revision Surgery Rheumatic Diseases Rheumatoid Arthritis Skin and Connective Tissue Diseases Trauma Wounds and Injuries

Sex eligibility

All sexes

Study type

Observational

Primary location

Nova Scotia Health Authority, Halifax, Nova Scotia, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Comprehensive SRS Replacement

Device

This system consist of a proximal humeral replacement, distal humeral replacement, or total humeral replacement.

Primary outcomes

  1. Implant survivorship assessed according to the implant revisions

    Time frame: 10 years

    Implant survivorship assessed counting the number of implant revisions

Secondary outcomes

  1. Clinical patient outcome measure: QuickDASH

    Time frame: 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.

  2. Clinical patient outcome measure: Constant-Murley Score

    Time frame: 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.

  3. Clinical patient outcome measure: Liverpool Elbow Score

    Time frame: 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.

  4. Clinical patient outcome measure: Musculoskeletal Tumour Society Scoring System (MSTS)

    Time frame: 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.

  5. Safety is assessed according to the number of complications

    Time frame: 10 years

    Safety is assessed according to the number of complications which are collected via adverse event forms

Sponsors and collaborators

Lead sponsor

Zimmer Biomet

Industry

Registry information

Important dates

Study start
2016
Primary completion
2035
Study completion
2035
First posted
Sep 1, 2017
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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