Comprehensive Reverse Shoulder Data Collection

Comprehensive Reverse Shoulder Clinical Outcomes Study

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Osteoarthritis of the Shoulder; Arthropathy of Shoulder Region; Grossly Deficient Rotator Cuff; Rheumatoid Arthritis Without Humeral Metaphyseal Defects; Post-Traumatic Arthitis
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Estimated): 175

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Towson, Maryland, United States, 21204
      • Acromion LLC
  • Michigan
    • Royal Oak, Michigan, United States, 48073
      • William Beaumont Hospital
  • Minnesota
    • Edina, Minnesota, United States, 55439
      • Allina Health System DBA Sports and Orthopaedic Specialists
  • Ohio
    • New Albany, Ohio, United States, 43054
      • Joint Implant Surgeons

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Constant Shoulder Score	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.	Pre-operative, 3 months, 6 months, 1 year, 3 years, 5 years, 7 years, 10 years
Presence of Scapular Notching	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.	3 months, 6 months, 1 year, 3 years, 5 years, 7 years, 10 years

Collaborators and Investigators

• Sponsor: Zimmer Biomet

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2010
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2036

Study Registration Dates

• First Submitted: January 12, 2018
• First Submitted That Met QC Criteria: January 12, 2018
• First Posted (Actual): January 19, 2018

Study Record Updates

• Last Update Posted (Estimated): October 30, 2025
• Last Update Submitted That Met QC Criteria: October 28, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Safety; Performance; Medical Device; Reverse Shoulder Arthroplasty; Shoulder Prosthesis; Glenoid Erosion
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Rheumatic Diseases; Joint Diseases; Osteoarthritis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents; Enzyme Inhibitors; Histamine Antagonists; Histamine Agents; Neurotransmitter Agents; Cytochrome P-450 Enzyme Inhibitors; Cytochrome P-450 CYP1A2 Inhibitors; Anti-Ulcer Agents; Histamine H2 Antagonists; Cimetidine
• Other Study ID Numbers: ORTHO.CR.EX007

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes