MDR - Comprehensive Reverse/Versa Dial Ti Glenosphere

NCT04003272 | Enrolling By Invitation FDA Device

• 1 other identifier: MDRG2017-89MS-40E
• Study Type: observational
• Target: 59
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Shoulder Pain; Shoulder Injuries; Shoulder Fractures; Shoulder Arthritis; Shoulder Disease

Outcome Measures

Primary Outcomes (1)

• Product Safety assessed through the incidence and frequency of revisions, complications and adverse events

  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.

  Out to 10 years

Secondary Outcomes (2)

• Product Clinical Benefits and Performance evaluated through the Oxford Shoulder Scale OSS or Oxford Shoulder Questionnaire.

  Out to10 years

• Product Clinical Benefits and Performance evaluated through the Patient Assessment Questionnaire

  Out to 10 years

Study Arms (1)

Comprehensive Reverse Versa-Dial Titanium Glenosphere

Patients who have an allergy to typical cobalt chrome or other metal allergies had surgery to repair shoulder malfunction/disease.

Device: Comprehensive Reverse Versa-Dial Titanium Glenosphere

Interventions

Comprehensive Reverse Versa-Dial Titanium Glenosphere DEVICE

Implant used for patients with allergy to typical device material metals to repair shoulder malfunction/disease.

Comprehensive Reverse Versa-Dial Titanium Glenosphere

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive series of subjects implanted with the Comprehensive Versa-Dial Reverse Titanium (Ti) Glenosphere in primary, fracture and revision total shoulder arthroplasty according to the approved indications. Inclusion/exclusion criteria are identical to the indications and contraindications in the IFU.

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Current alcohol or drug abuser.
• If female, patient is known to be pregnant or breastfeeding.
• Patient has a psychiatric illness or cognitive deficit that will not allow from proper informed consent.

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (2)

Norton Orthopaedic and Sports Medicine

Louisville, Kentucky, 40241, United States

Location

University of Buffalo

Buffalo, New York, 14215, United States

Location

MeSH Terms

Conditions

Shoulder Pain; Shoulder Injuries; Shoulder Fractures

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Wounds and Injuries; Fractures, Bone

Study Officials

• Erin Osborn

  Zimmer Biomet

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2019
• First Posted: July 1, 2019
• Study Start: October 28, 2019
• Primary Completion (Estimated): August 19, 2034
• Study Completion (Estimated): September 1, 2035
• Last Updated: February 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)