Comprehensive Segmental Revision System

March 5, 2024 updated by: Zimmer Biomet
Clinical Data evaluation to document the performance and clinical outcomes of the Comprehensive Segmental Revision System.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 ten (10) years from the time of surgery.

Study Type

Observational

Enrollment (Estimated)

105

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H-1796
        • Recruiting
        • Nova Scotia Health Authority
        • Contact:
          • Kelly Trask
        • Principal Investigator:
          • Michael Biddulph
  • Denmark
      • Copenhagen, Denmark
        • Recruiting
        • Department of Orthopedic Surgery, Rigshospitalet University of Copenhagen
        • Contact:
  • United Kingdom
      • Liverpool, United Kingdom
        • Recruiting
        • Royal Liverpool University Hospital
        • Contact:
          • Yin Qi, MD
    • Wales
      • Newport, Wales, United Kingdom, NP20 2UB
        • Active, not recruiting
        • Royal Gwent Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Study population will come from Primary Care Clinics

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implant survivorship assessed according to the implant revisions
Time Frame: 10 years
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
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.
Pre-operative and at 6 months, 1 year, 3 years and 5 years post-operative
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.
Pre-operative and at 6 months, 1 year, 3 years and 5 years post-operative
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.
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)
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.
6 months, 1 year, 3 years and 5 years post-operative
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
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zimmer Biomet

Investigators

  • Study Director: Hassan Achakri, Clinical Operations Director Zimmer Biomet EMEA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2016

Primary Completion (Estimated)

December 1, 2034

Study Completion (Estimated)

December 1, 2034

Study Registration Dates

First Submitted

August 30, 2017

First Submitted That Met QC Criteria

August 31, 2017

First Posted (Actual)

September 1, 2017

Study Record Updates

Last Update Posted (Estimated)

March 6, 2024

Last Update Submitted That Met QC Criteria

March 5, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ORTHO.CR.GE5

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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