MDR - Comprehensive Reverse/Versa Dial Ti Glenosphere
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Comprehensive Reverse Versa-Dial Titanium Glenosphere.
- Who it may be relevant to
- Registry conditions: Shoulder Pain, Shoulder Injuries, Shoulder Fractures, Shoulder Arthritis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Post-market Clinical Follow-up Study to Provide Safety, Performance and Clinical Benefits Data of the Comprehensive Versa-Dial Reverse Titanium (Ti) Glenosphere in Primary, Fracture and Revision Total Shoulder Arthroplasty
Overview
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.
Detailed description
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 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.
Interventions
- Device Comprehensive Reverse Versa-Dial Titanium Glenosphere
Implant used for patients with allergy to typical device material metals to repair shoulder malfunction/disease.
Primary outcome measures
- Product Safety assessed through the incidence and frequency of revisions, complications and adverse events [Time frame: Out to 10 years]
Secondary outcome measures (2)
- Product Clinical Benefits and Performance evaluated through the Oxford Shoulder Scale OSS or Oxford Shoulder Questionnaire. [Time frame: Out to10 years]
- Product Clinical Benefits and Performance evaluated through the Patient Assessment Questionnaire [Time frame: Out to 10 years]
Eligibility criteria
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:
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 2 centers
- Norton Orthopaedic and Sports Medicine — Louisville
- University of Buffalo — Buffalo
Identifiers
NCT: NCT04003272 · MDRG2017-89MS-40E