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Enrolling by Invitation

NCT Number: NCT03404778

Comprehensive Reverse Shoulder Data Collection

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.

Enrolling by Invitation

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Acromion LLC, Towson, Maryland, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Pain Score

    Time frame: 1 year

    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.

Secondary outcomes

  1. Constant Shoulder Score

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

    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.

  2. Presence of Scapular Notching

    Time frame: 3 months, 6 months, 1 year, 3 years, 5 years, 7 years, 10 years

    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.

Sponsors and collaborators

Lead sponsor

Zimmer Biomet

Industry

Registry information

Official study title

Comprehensive Reverse Shoulder Clinical Outcomes Study

Important dates

Study start
2010
Primary completion
2026
Study completion
2036
First posted
Jan 19, 2018
Registry last updated
Oct 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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