An observational study in Arthropathy of Shoulder Region, Grossly Deficient Rotator Cuff and Osteoarthritis of the Shoulder, sponsored by Zimmer Biomet. Enrolling by invitation at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-30.
Sponsored by Zimmer Biomet · Observational
Among 59 studies in Arthritis, Rheumatoid by Zimmer Biomet — 4 open to participants now, 22 under way, none of them phase 3. Arthritis, Rheumatoid · Zimmer Biomet.
Among the 59 studies in Arthritis, Rheumatoid by Zimmer Biomet, this one is the 13th largest by planned enrollment of the 34 observational ones that give a count, is one of 5 that started in 2010, is one of 34 observational ones, reaches primary completion later than 5 of the 21 other live ones, and was the 32nd registered.
3,332 studies on the registry are indexed under Arthritis, Rheumatoid; 443 are open to participants now.
Browse Arthritis, Rheumatoid studies →4 of the 59 studies in Arthritis, Rheumatoid by Zimmer Biomet are open now, in 5 countries. Recruiting first, the newest first:
Zimmer Biomet · Sites in Japan
Zimmer Biomet · Sites in United States
Zimmer Biomet · Sites in United States, Belgium, Italy and 1 more country
By country, each count listing its studies:
Of the 293 Arthritis, Rheumatoid studies recruiting now, 150 (51%) set no upper age limit and 109 (37%) stop at 75 or younger; 15 take children under 18; 36 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
59 studies; the count open now beside each. This study's row is marked.
First in 2004; this study’s year is marked. 5 started in 2010.
This study's planned enrollment of 175 is close to the median of 176 across 1,016 observational studies indexed under Arthritis, Rheumatoid.
Median enrollment 148 across the 25 interventional studies, 156 across the 34 observational. Of the 33 that completed or were terminated, 18 (55%) have results posted.
This tab as a report to print or save as PDF → With an account.
Zimmer Biomet is the lead sponsor of 275 studies on the registry; 28 are open to participants now.
Of its 22 completed or terminated interventional studies of FDA-regulated products, 19 (86%) have results posted.
6 of the studies in Arthritis, Rheumatoid by Zimmer Biomet that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03409718Zimmer BiometDatabase Retrieval for the Comprehensive Shoulder | 2026-12 |
| NCT01480440Zimmer BiometOutcomes Study of the Trabecular Metal (TM) Reverse Shoulder System | 2026-12 |
| NCT03626038Zimmer BiometPost Market Clinical Follow-up (PMCF) Study of the A.L.P.S. Proximal Humerus Plating System | 2026-12 |
| NCT03404778Zimmer BiometComprehensive Reverse Shoulder Data Collection | 2026-12 |
| NCT05966519Zimmer BiometROSA Knee Intraoperative Planning Flexibility Study | 2027-01 |
Among the 59 studies in Arthritis, Rheumatoid by Zimmer Biomet, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Time frame: 1 year
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.
Time frame: 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.
Time frame: 3 months, 6 months, 1 year, 3 years, 5 years, 7 years, 10 years
Started Mar 2010 (actual). Primary completion is estimated for Dec 2026, 201 months after the start.
Of 155 industry-sponsored observational studies under Arthritis, Rheumatoid, half reached primary completion within 61 months of starting (the median), counting those still running; a quarter within 32 and three quarters within 116. This study's planned 201 months is above that.
Counting every sponsor, half of 389 studies reached it within 50 months; a quarter within 25 and three quarters within 113.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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