Comprehensive Segmental Revision System

Last updated: September 1, 2025
Sponsor: Zimmer Biomet
Overall Status: Active - Recruiting

Phase

N/A

Condition

Rheumatoid Arthritis

Joint Injuries

Hyponatremia

Treatment

Comprehensive SRS Replacement

Clinical Study ID

NCT03270982
ORTHO.CR.GE5
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Non Inflammatory Degenerative joint disease, including osteoarthritis, and avascularnecrosis

  • Rheumatoid arthritis

  • Revision where other devices or treatments have failed

  • Correction of functional deformity

  • Oncology applications including bone loss due to tumour resection

Exclusion

Exclusion Criteria:

  • Sepsis ( active)

  • Infection ( active)

  • Osteomyelitis (active)

Study Design

Total Participants: 105
Treatment Group(s): 1
Primary Treatment: Comprehensive SRS Replacement
Phase:
Study Start date:
April 01, 2016
Estimated Completion Date:
December 31, 2035

Study 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.

Connect with a study center

  • Nova Scotia Health Authority

    Halifax, Nova Scotia B3H-1796
    Canada

    Site Not Available

  • Nova Scotia Health Authority

    Halifax 6324729, Nova Scotia 6091530 B3H-1796
    Canada

    Active - Recruiting

  • Department of Orthopedic Surgery, Rigshospitalet University of Copenhagen

    Copenhagen,
    Denmark

    Site Not Available

  • Department of Orthopedic Surgery, Rigshospitalet University of Copenhagen

    Copenhagen 2618425,
    Denmark

    Active - Recruiting

  • Royal Gwent Hospital

    Newport, Wales NP20 2UB
    United Kingdom

    Site Not Available

  • Royal Gwent Hospital

    Newport 2641598, Wales 2634895 NP20 2UB
    United Kingdom

    Completed

  • Royal Liverpool University Hospital

    Liverpool,
    United Kingdom

    Site Not Available

  • Royal Liverpool University Hospital

    Liverpool 2644210,
    United Kingdom

    Active - Recruiting

  • Royal National Orthopaedic Hospital

    Stanmore,
    United Kingdom

    Site Not Available

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