MDR - Comprehensive Reverse/Versa Dial Ti Glenosphere

NCT04003272 · tracked via the Priya Life Science USA tracker

Sponsor

Zimmer Biomet

Phase

Observational

Started

2019-10-28

Last updated

2026-02-06

Condition(s) studied

Shoulder PainShoulder InjuriesShoulder FracturesShoulder ArthritisShoulder Disease

Investigational drug(s) / intervention(s)

Comprehensive Reverse Versa-Dial Titanium Glenosphere

Comprehensive Reverse Versa-Dial Titanium Glenosphere: Implant used for patients with allergy to typical device material metals to repair shoulder malfunction/disease.

Study summary

The objective of this retrospective/prospective consecutives series PMCF study is to collect data confirming safety, performance and clinical benefits of the Comprehensive Versa-Dial Reverse Ti Glenosphere when used for primary total shoulder arthroplasty (implants and instrumentation) at a 1,2,3,5,7, and 10- year follow-up\* to meet EU Medical Device and other Regulatory Requirements for Post-Market Surveillance. Because Comprehensive Versa-Dial Reverse Ti Glenospheres have only been on the market since 2009, a prospective aspect to the study will be utilized as well to collect long-term data.

\*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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * 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. Glenoid components with Hydroxyapatite (HA) coating applied over the porous coating are indicated only for uncemented biological fixation applications. The Glenoid Baseplate components are intended for cementless application with the addition of screw fixation. Interlok™ finish humeral stems are intended for cemented use and the MacroBond™ coated humeral stems are intended for press-fit or cemented applications. Humeral components with porous coated surface coating are indicated for either cemented or uncemented biological fixation applications. \*\*\* For the specific components, Titanium (Ti) Glenospheres are intended for patients with Cobalt Alloy material sensitivity. Exclusion Criteria: * Absolute contraindications include infection, sepsis, and osteomyelitis. Relative contraindications include: 1. Uncooperative patient or patient with neurologic disorders who is incapable or unwilling to follow directions. 2. Osteoporosis. 3. Metabolic disorders which may impair bone formation. 4. Osteomalacia. 5. Distant foci of infections which may spread to the implant site. 6. Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram. 7. Patient is a prisoner. 8. Current alcohol or drug abuser. 9. If female, patient is known to be pregnant or breastfeeding. 10. Patient has a psychiatric illness or cognitive deficit that will not allow from proper informed consent.

Primary outcome measure(s)

Product Safety assessed through the incidence and frequency of revisions, complications and adverse events — Out to 10 years
The primary objective 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.

Trial sites (2)

Facility	City	Region	Status
Norton Orthopaedic and Sports Medicine	Louisville	Kentucky
University of Buffalo	Buffalo	New York

More Zimmer Biomet trials in the USA

Zimmer Biomet Shoulder Arthroplasty PMCF Recruiting

Database Retrieval for the Comprehensive Shoulder Active, not recruiting

Comprehensive Reverse Shoulder Data Collection Enrolling by invitation

Cemented vs Cementless Persona Keel RCT Active, not recruiting

Post Market Clinical Follow-up (PMCF) Study of the A.L.P.S. Proximal Humerus Plating System Active, not recruiting

Other trials for the same condition

Zimmer Biomet Shoulder Arthroplasty PMCF Recruiting

AETOS Shoulder System Recruiting

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

SportsPro: Post-Market Clinical Follow Up Study Recruiting

OsseoFit Stemless Shoulder System (Anatomic) Enrolling by invitation

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04003272 on ClinicalTrials.gov ↗ ← All trials in the USA