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MDR - Comprehensive Primary/Micro Stem & Versa-Dial Ti Humeral Head | Clinical Trials | Clareo Health

ENROLLING_BY_INVITATION

MDR - Comprehensive Primary/Micro Stem & Versa-Dial Ti Humeral Head

Comprehensive® Primary Micro Stem and Comprehensive® Anatomic Versa-Dial Titanium Humeral Heads in Primary and Revision Total Shoulder Arthroplasty

NCT04003311•Zimmer Biomet

View on ClinicalTrials.gov

Summary

Detailed Description

The objective of this retrospective/prospective enrollment and prospective follow-up consecutive series PMCF study is to collect data confirming safety, performance and clinical benefits of the Comprehensive Primary Micro Stem and Comprehensive Anatomic Versa-Dial Titanium Humeral Heads when used for primary and revision total shoulder arthroplasty (implants and instrumentation) at 1,2,3,5,7 and 10 years\*. Comprehensive Primary Micro Stem and Comprehensive Anatomic Versa-Dial Titanium Humeral Heads have been on the market since 2007, but have insufficient data to support 10 years of clinical history. Therefore, a prospective aspect to the study will be utilized in order to collect long-term data. The primary objective of this study is the assessment of safety by analyzing implant survivorship. This will be established by recording the incidence and frequency of revisions, complications, and adverse events. Relation of the events to either implant or instrumentation should be specified. The secondary objective is the assessment of performance and clinical benefits by recording patient-reported clinical outcomes measures (PROMs). \*The most recent available data will be used. If any of the listed time points are not available, data will be used from last available time point and follow-up will move forward at the closest available time point.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Study devices must have been implanted following the surgical technique and IFU for the Comprehensive Micro Stem and/or the Comprehensive Anatomic Versa-Dial Humeral Heads
•Patient must be 18 years of age or older.
•Patient must have undergone a primary or revision shoulder arthroplasty with the Comprehensive Micro Stem and/or the Comprehensive Anatomic Versa-Dial Humeral Heads for a cleared indication. Cleared indications include the following:
•* 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 arthroplasty where other treatment methods may not be suitable or may be inadequate.

Exclusion Criteria

•Absolute contraindications include infection, sepsis, and osteomyelitis.
•Relative contraindications include:
•* 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
•Patient is a prisoner.
•Patient is a current alcohol or drug abuser.
+2 more criteria

Locations (4)

Shoulder Clinic of Idaho

Boise, Idaho, United States

Beaumont Health

Royal Oak, Michigan, United States

University of Rochester

Rochester, New York, United States

Department of Orthopaedics & Rehabilitation The Larner College of Medicine at The University of Vermont

Burlington, Vermont, United States

Key Dates

Start Date

December 13, 2019

Primary Completion Date

July 29, 2028

Completion Date

July 29, 2028

Last Updated

October 30, 2025

Enrollment

146

ESTIMATED participants

Conditions

Shoulder PainShoulder InjuriesShoulder FracturesShoulder DiseaseShoulder Arthritis

Interventions

Comprehensive Primary Micro Stem

DEVICE

Comprehensive Anatomic Versa-Dial Titanium Humeral Head

DEVICE

Subscapularis Repair Augmentation for Total Shoulder Arthroplasty

NCT05487677

Shoulder Injuries

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RECRUITINGNA

Embolization Treatment of Chronic Refractory Shoulder Tendinopathy

NCT06095050

Shoulder PainTendinopathy+4 more

View study

RECRUITINGNA

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 30, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

MDR - Comprehensive Primary/Micro Stem & Versa-Dial Ti Humeral Head

Inclusion Criteria

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