Comprehensive Reverse Shoulder Data Collection

NCT03404778 | Enrolling By Invitation FDA Device

• 1 other identifier: ORTHO.CR.EX007
• Study Type: observational
• Target: 175
• Locations: 1 country
• Sites: 4

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.

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

Outcome Measures

Primary Outcomes (1)

• Pain Score

  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.

  1 year

Secondary Outcomes (2)

• Constant Shoulder Score

  Pre-operative, 3 months, 6 months, 1 year, 3 years, 5 years, 7 years, 10 years

• Presence of Scapular Notching

  3 months, 6 months, 1 year, 3 years, 5 years, 7 years, 10 years

Study Arms (1)

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

Interventions

Biomet Comprehensive Reverse Shoulder DEVICE

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.

Biomet Comprehensive Reverse Shoulder

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (4)

Acromion LLC

Towson, Maryland, 21204, United States

Location

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

Allina Health System DBA Sports and Orthopaedic Specialists

Edina, Minnesota, 55439, United States

Location

Joint Implant Surgeons

New Albany, Ohio, 43054, United States

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2018
• First Posted: January 19, 2018
• Study Start: March 7, 2010
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2036
• Last Updated: October 30, 2025

Record last verified: 2025-10

Locations

US (4)