NCT03404778Enrolling by invitation
Comprehensive Reverse Shoulder Data Collection
Comprehensive Reverse Shoulder Clinical Outcomes Study
Source: ClinicalTrials.gov · Last updated 30 Oct 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Observational
- Enrollment
- 175 (estimated)
- First submitted
- 12 Jan 2018
- Start date
- 7 Mar 2010
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Zimmer Biomet
- Diseases
- Rheumatoid arthritis
- NCT number
- NCT03404778
What you commit to
- Study type: Observational
- Planned participants: 175
- From 7 Mar 2010 to the primary completion date, 31 Dec 2026
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Other
- Osteoporosis.
- Osteomalacia.
- Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Allina Health System DBA Sports and Orthopaedic Specialists Coordinator of this site? Confirm its status | Edina | United States | Unknown status |
| Joint Implant Surgeons Coordinator of this site? Confirm its status | New Albany | United States | Unknown status |
| William Beaumont Hospital Coordinator of this site? Confirm its status | Royal Oak | United States | Unknown status |
| Acromion LLC Coordinator of this site? Confirm its status | Towson | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.