An observational study in Osteoarthritis of the Shoulder, Avascular Necrosis and Rheumatoid Arthritis, sponsored by Zimmer Biomet. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-10.
Sponsored by Zimmer Biomet · Observational
This study is a retrieval of database information regarding survivorship of the Comprehensive Shoulder System family of products. The primary objective of the retrieval is to collect data that will contribute to the post market surveillance requirements for this product and will provide feedback to design engineers, support marketing efforts and publications, and answer potential questions form reimbursement agencies.
The Comprehensive Shoulder System has been cleared by the FDA via premarket notifications. No experimental or investigational surgical techniques or devices will be used in this study. All devices and products will be used in accordance with their instructions for use and/or approved labeling. The aim of the Comprehensive Shoulder System is to improve shoulder function and reduce pain.
One site will be used for this database retrieval. The number of patients involved will depend upon the size of the Comprehensive database available at Acromion, LLC.
286 studies on the registry are indexed under Osteonecrosis; 45 are open to participants now.
This study's enrollment of 160 is above the median of 121 across 127 observational studies indexed under Osteonecrosis.
Browse Osteonecrosis studies →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.
Counted across the registry records on this site, refreshed daily.
Patients in need of a total shoulder arthroplasty which receive one of the devices in the Comprehensive Shoulder family 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 total shoulder arthroplasty who met the inclusion/exclusion criteria and received the Comprehensive Shoulder System.
Device: Biomet Comprehensive Shoulder System
Total shoulder system designed to provide intraoperative flexibility for surgeons with unmatched humeral stem options, and infinite humeral head offset possibilities while meeting the growing demand for ease of glenoid preparation through a streamlined, low-profile, cannulated instrument platform
Implant survivorship is assessed counting the number of implant revisions
Implant survivorship will be documented by assessing the number of implant revisions occurring throughout the course of the study.
Time frame: 10 years
Constant Shoulder Score
The Constant-Murley Shoulder Score is a scoring method used by clinicians to assess function of the shoulder. The standard score is on a scale of 0 to 100, with 0 being no shoulder function and 100 being excellent function.
Time frame: 10 years
Clinical Safety
Clinical safety is assessed through documentation of complications occurring during the course of the study.
Time frame: 10 years
Clinical Safety - Device Related
Clinical safety is assessed through documentation of device-related events occurring during the course of the study.
Time frame: 10 years
Started Feb 2011 (actual). Primary completion is estimated for Dec 2026, 190 months after the start.
Of 59 observational studies under Osteonecrosis, half reached primary completion within 141 months of starting (the median), counting those still running; a quarter within 93 and three quarters within 184. This study's planned 190 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.