Clinical trial NCT03404778: Comprehensive Reverse Shoulder Data Collection
Official title: Comprehensive Reverse Shoulder Clinical Outcomes Study
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Arthropathy of Shoulder Region
Grossly Deficient Rotator Cuff
Osteoarthritis of the Shoulder
Rheumatoid Arthritis Without Humeral Metaphyseal Defects
Post-Traumatic Arthitis
Keywords: Reverse Shoulder Arthroplasty
Medical Device
Performance
Safety
Shoulder Prosthesis
Glenoid Erosion
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2018-01-19
Enrollment: 175
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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.

Primary outcomes:
measure: Pain Score
timeFrame: 1 year
Secondary outcomes:
measure: Constant Shoulder Score
timeFrame: Pre-operative, 3 months, 6 months, 1 year, 3 years, 5 years, 7 years, 10 years
measure: Presence of Scapular Notching
timeFrame: 3 months, 6 months, 1 year, 3 years, 5 years, 7 years, 10 years
Other outcomes:
Locations:
city: Towson
country: United States
facility: Acromion LLC
state: Maryland
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Edina
country: United States
facility: Allina Health System DBA Sports and Orthopaedic Specialists
state: Minnesota
city: New Albany
country: United States
facility: Joint Implant Surgeons
state: Ohio
Study officials:
References: