Database Retrieval for the Comprehensive Shoulder

October 28, 2025 updated by: Zimmer Biomet

Comprehensive Shoulder System Database Retrieval

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

160

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Towson, Maryland, United States, 21204
        • Acromion LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

  • Must have one of the following indications:
  • Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
  • Rheumatoid arthritis
  • Revision where other devices or treatments have failed.
  • Correction of functional deformity.
  • Fractures of the proximal humerus, where other methods of treatment are deemed inadequate.
  • Difficult clinical management problems, including cuff arthropathy, where other methods of treatment may not be suitable or may be inadequate.
  • Need to obtain pain relief and improve function
  • Ability and willingness of the patient to follow instructions, including control of weight and activity level
  • A good nutritional state of the patient
  • The patient must have reached full skeletal maturity

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Biomet Comprehensive Shoulder System
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implant survivorship is assessed counting the number of implant revisions
Time Frame: 10 years
Implant survivorship will be documented by assessing the number of implant revisions occurring throughout the course of the study.
10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Constant Shoulder Score
Time Frame: 10 years
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.
10 years
Clinical Safety
Time Frame: 10 years
Clinical safety is assessed through documentation of complications occurring during the course of the study.
10 years
Clinical Safety - Device Related
Time Frame: 10 years
Clinical safety is assessed through documentation of device-related events occurring during the course of the study.
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zimmer Biomet

Investigators

  • Study Director: Erin D Osborn, Zimmer Biomet

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 24, 2011

Primary Completion (Estimated)

February 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

January 18, 2018

First Submitted That Met QC Criteria

January 18, 2018

First Posted (Actual)

January 24, 2018

Study Record Updates

Last Update Posted (Estimated)

October 30, 2025

Last Update Submitted That Met QC Criteria

October 28, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ORTHO.CR.EX003

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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