Comprehensive Reverse Shoulder Data Collection

Conditions

• Arthropathy of Shoulder Region
• Grossly Deficient Rotator Cuff
• Osteoarthritis of the Shoulder
• Post-Traumatic Arthitis
• Rheumatoid Arthritis Without Humeral Metaphyseal Defects

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

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.

Study Details

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.

Key Dates

Start date

Mar 7, 2010

Status verified

Oct 2025

Primary completion

Dec 31, 2026

Completion

Dec 31, 2036

Study Design

Enrollment

175 participants (estimated)

Arms

• Arm: 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.

Primary Outcome Measure

Pain Score [ Time Frame: 1 year ]

Locations (4)

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