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Comprehensive Reverse Shoulder Data Collection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03404778
Recruitment Status : Enrolling by invitation
First Posted : January 19, 2018
Last Update Posted : November 9, 2021
Sponsor:
Information provided by (Responsible Party):
Zimmer Biomet

Study Description
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Brief Summary:
This study is a multicenter, prospective, non-randomized, non-controlled clinical outcome study. The primary objective of this study is to evaluate improvement of pain score at one year for the Biomet Comprehensive Reverse Shoulder. The secondary objective is collection of long term clinical outcomes.

Condition or disease Intervention/treatment
Arthropathy of Shoulder Region Grossly Deficient Rotator Cuff Osteoarthritis of the Shoulder Rheumatoid Arthritis Without Humeral Metaphyseal Defects Post-Traumatic Arthitis Device: Biomet Comprehensive Reverse Shoulder

Detailed Description:

The Biomet Comprehensive Reverse Shoulder was developed to provide an additional surgical option for patients anatomically and structurally suited to receive a reverse shoulder arthroplasty. The aim of the Biomet Comprehensive Reverse Shoulder is to increase shoulder function while reducing pain.

This is a multi-center study. Having several clinical sites will allow for multiple investigators to contribute to the results of the study. 175 implants will be included into the study. All potential study subjects will be required to participate in the Informed Consent Process.

Study Design
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Study Type : Observational
Estimated Enrollment : 175 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comprehensive Reverse Shoulder Clinical Outcomes Study
Actual Study Start Date : March 7, 2010
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2032

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Biomet Comprehensive Reverse Shoulder
Subjects in need of a reverse shoulder arthroplasty who met the inclusion/exclusion criteria and received the Comprehensive Reverse Shoulder System.
 Device: Biomet Comprehensive Reverse Shoulder
Designed to eliminate the potential for scapular notching, this reverse shoulder system combines a a true locking mechanism that minimized wear and oxidative breakdown with a modular central screw for secure fixation.


Outcome Measures
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Primary Outcome Measures :
  1. Pain Score [ Time Frame: 1 year ]
    Pain Score is assessed for each subject by asking them to indicate their current level of pain based on a 5 level scale, with "None" as the best outcome and "Severe" as the worst. Improvement of pain score at one year from pre-operative levels will be assessed.


Secondary Outcome Measures :
  1. Constant Shoulder Score [ Time Frame: Pre-operative, 3 months, 6 months, 1 year, 3 years, 5 years, 7 years, 10 years ]
    The Constant-Murley Shoulder Score is a scoring method used by clinicians to assess function of the shoulder. The score is on a scale of 0 to 100, with 0 being no shoulder function and 100 being excellent function.

  2. Presence of Scapular Notching [ Time Frame: 3 months, 6 months, 1 year, 3 years, 5 years, 7 years, 10 years ]
    All radiographic images collected during the study are assessed by the Principal Investigator for the presence of scapular notching. The severity of notching will be assessed using the Nerot system, where Grade 0 indicates no notch and Grade 4 indicates the largest-sized defect in the scapula.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients in need of a reverse shoulder arthroplasty which receive the Biomet Comprehensive Reverse Shoulder and who meet all of the inclusion and none of the exclusion criteria.
Criteria

Inclusion Criteria:

  • Biomet® Comprehensive™ Reverse Shoulder products are indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff.
  • The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary.
  • The Comprehensive® Reverse Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.

Exclusion Criteria:

  • Absolute contraindications include infection, sepsis, and osteomyelitis.
  • Uncooperative patient or patient with neurologic disorders who is incapable or unwilling to follow directions.
  • Osteoporosis.
  • Metabolic disorders which may impair bone formation.
  • Osteomalacia.
  • Distant foci of infections which may spread to the implant site.
  • Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram.
Contacts and Locations
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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): NCT03404778


Locations
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United States, Maryland
Acromion LLC
Towson, Maryland, United States, 21204
United States, Michigan
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
United States, Minnesota
Allina Health System DBA Sports and Orthopaedic Specialists
Edina, Minnesota, United States, 55439
United States, Ohio
Joint Implant Surgeons
New Albany, Ohio, United States, 43054
Sponsors and Collaborators
Zimmer Biomet
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Zimmer Biomet
ClinicalTrials.gov Identifier: NCT03404778    
Other Study ID Numbers: ORTHO.CR.EX007
First Posted: January 19, 2018    Key Record Dates
Last Update Posted: November 9, 2021
Last Verified: November 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Zimmer Biomet:
Reverse Shoulder Arthroplasty
Medical Device
Performance
 Safety
Shoulder Prosthesis
Glenoid Erosion
Additional relevant MeSH terms:
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Osteoarthritis
Joint Diseases
Arthritis
Musculoskeletal Diseases
Rheumatic Diseases
Cimetidine
Anti-Ulcer Agents
Gastrointestinal Agents
Histamine H2 Antagonists
 Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors