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Comprehensive Segmental Revision System

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ClinicalTrials.gov Identifier: NCT03270982
Recruitment Status : Recruiting
First Posted : September 1, 2017
Last Update Posted : July 20, 2021
Sponsor:
Information provided by (Responsible Party):
Zimmer Biomet

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

Condition or disease Intervention/treatment
Degenerative Disease Oncology Revision Surgery Trauma Rheumatoid Arthritis Device: Comprehensive SRS Replacement

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 five (5) years from the time of surgery.

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Comprehensive Segmental Revision System
Actual Study Start Date : April 2016
Estimated Primary Completion Date : April 2026
Estimated Study Completion Date : December 2030

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Comprehensive SRS Replacement Device: Comprehensive SRS Replacement
This system consist of a proximal humeral replacement, distal humeral replacement, or total humeral replacement.




Primary Outcome Measures :
  1. Implant survivorship assessed according to the implant revisions [ Time Frame: 10 years ]
    Implant survivorship assessed counting the number of implant revisions


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Study population will come from Primary Care Clinics
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03270982


Contacts
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Contact: Oliver Schaetti, PhD +41 58 854 89 01 oliver.schaetti@zimmerbiomet.com
Contact: Paola Vivoda +41 58 854 82 06 paola.vivoda@zimmerbiomet.com

Locations
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Canada, Nova Scotia
Nova Scotia Health Authority Recruiting
Halifax, Nova Scotia, Canada, B3H-1796
Contact: Kelly Trask         
Principal Investigator: Michael Biddulph         
Denmark
Department of Orthopedic Surgery, Rigshospitalet University of Copenhagen Recruiting
Copenhagen, Denmark
Contact: Michael Mork Petersen, MD    004522400743    michael.moerk.petersen@regionh.dk   
United Kingdom
Royal Gwent Hospital Recruiting
Newport, Wales, United Kingdom, NP20 2UB
Contact: Huw Pullen, MD    +441633 234839    pullenhuw@Hotmail.com   
University of Liverpool Recruiting
Liverpool, United Kingdom
Contact: Mohamed Galhoum, MD    +447920405089    mohamed.galhoum@doctors.org.uk   
Sponsors and Collaborators
Zimmer Biomet
Investigators
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Study Chair: Oliver Schaetti, PhD Zimmer Biomet, Jr. Clinical Project Lead
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Responsible Party: Zimmer Biomet
ClinicalTrials.gov Identifier: NCT03270982    
Other Study ID Numbers: ORTHO.CR.GE5
First Posted: September 1, 2017    Key Record Dates
Last Update Posted: July 20, 2021
Last Verified: July 2021

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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
Keywords provided by Zimmer Biomet:
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
Additional relevant MeSH terms:
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Neoplasms
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases