Status:
ENROLLING_BY_INVITATION
Comprehensive Reverse Shoulder Data Collection
Lead Sponsor:
Zimmer Biomet
Conditions:
Arthropathy of Shoulder Region
Grossly Deficient Rotator Cuff
Eligibility:
All Genders
18+ years
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...
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 o...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 7 2010
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2036
Estimated Enrollment :
175 Patients enrolled
Trial Details
Trial ID
NCT03404778
Start Date
March 7 2010
End Date
December 1 2036
Last Update
October 30 2025
Active Locations (4)
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1
Acromion LLC
Towson, Maryland, United States, 21204
2
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
3
Allina Health System DBA Sports and Orthopaedic Specialists
Edina, Minnesota, United States, 55439
4
Joint Implant Surgeons
New Albany, Ohio, United States, 43054