Tracks shoulder outcomes after a reverse shoulder implant in adults
Follows adults with severe shoulder joint damage who receive a Biomet reverse shoulder implant.
Plain-language title generated from the registry record
Registry title: Comprehensive Reverse Shoulder Data Collection
Key facts
- Where
- Edina, New Albany, Royal Oak, and Towson, United StatesSee the 4 sites
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults whose shoulder has a very weak rotator cuff with severe joint damage, or whose earlier shoulder replacement failed. They would receive the Biomet Comprehensive Reverse Shoulder.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Severe shoulder joint damage with a grossly deficient rotator cuff, or a failed earlier shoulder joint replacement. A working deltoid muscle is needed.
- Earlier treatment
- People with a failed earlier shoulder joint replacement can join. The record asks for no other prior treatment.
Main reasons for not taking part
- Infection, sepsis or osteomyelitis
- Osteoporosis, osteomalacia or metabolic disorders that may impair bone formation
- Uncooperative patients, or neurologic disorders that prevent following directions
- Infection elsewhere in the body that may spread to the implant site
- Rapid joint destruction, marked bone loss or bone resorption on X-ray
Read by machine on 12 November 2026.
Where in United States
- Allina Health System DBA Sports and Orthopaedic SpecialistsEdina, United StatesNo longer taking part
- Joint Implant SurgeonsNew Albany, United StatesNo longer taking part
- William Beaumont HospitalRoyal Oak, United StatesNo longer taking part
- Acromion LLCTowson, United StatesNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Zimmer Biomet
- Trial code
- NCT03404778
- Record updated
- 30 October 2025
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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: Absolute contraindications include infection, sepsis, and osteomyelitis; Uncooperative patient or patient with neurologic disorders who is incapable or unwilling to follow directions; Metabolic disorders which may impair bone formation; Distant foci of infections which may spread to the implant site; Osteoporosis; Osteomalacia; Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram.