MDR - Comprehensive Reverse/Versa Dial Ti Glenosphere

Zimmer Biomet

Status: Invitation-only

Conditions: Shoulder Pain; Shoulder Injuries; Shoulder Arthritis; Shoulder Fractures; Shoulder Disease

Treatments: Device: Comprehensive Reverse Versa-Dial Titanium Glenosphere

Study type: Observational

Funder types: Industry

Identifiers

NCT04003272

MDRG2017-89MS-40E

Details and patient eligibility

About

The objective of this retrospective/prospective consecutive 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, fractures and revision 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 Reverse Ti Glenospheres have only been on the market since 2009, a prospective aspect to the study will be utilized as well in order to collect long-term data.

Full description

The objective of this retrospective/prospective consecutive 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, fractures and revision 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 Reverse Ti Glenospheres have only been on the market since 2009, a prospective aspect to the study will be utilized as well in order to collect long-term data.

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.

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.

Enrollment: 73 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

73 participants in 1 patient group

Comprehensive Reverse Versa-Dial Titanium Glenosphere

Description:

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

Treatment:

Device: Comprehensive Reverse Versa-Dial Titanium Glenosphere