MDR - Comprehensive Reverse/Versa Dial Ti Glenosphere

• Conditions: Shoulder Pain; Shoulder Injuries; Shoulder Arthritis; Shoulder Fractures; Shoulder Disease
• Interventions: Device: Comprehensive Reverse Versa-Dial Titanium Glenosphere

• Registration Number: NCT04003272
• Lead Sponsor: Zimmer Biomet

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2019-06-18
• Study First Submitted QC: 2019-06-26
• Study First Posted: 2019-07-01
• Study Start: 2019-10-28
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-13
• Last Update Posted: 2024-12-18
• Primary Completion: 2029-07-29
• Study Completion: 2029-07-29

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 73

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Comprehensive Reverse Versa-Dial Titanium Glenosphere	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.

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Product Clinical Benefits and Performance evaluated through the Patient Assessment Questionnaire	Out to 10 years	The secondary objective is the assessment of performance and clinical benefits by recording patient-reported clinical outcomes measures (PROMs). This will be accomplished through the use of the Patient Assessment Questionnaire where adverse events and/or complications (yes or no- if yes, an Adverse Event Report would be completed), patient's activity level with regard to operative side (wholly inactive, mostly inactive, sometimes participates in mild activities, regularly participates in mild activities, sometimes participates in moderate activities, regularly participates in moderate activities, regularly participates in active events, regularly participates in very active events, sometimes participates in impact sports, regularly participates in impact sports, or not recorded), and the Reported Score if Individual Scores are not available. (This would be the reported score of the Oxford Shoulder Scale as described above in Outcome 2).
Product Clinical Benefits and Performance evaluated through the Oxford Shoulder Scale OSS or Oxford Shoulder Questionnaire.	Out to10 years	The secondary objective is the assessment of performance and clinical benefits by recording patient-reported clinical outcomes measures (PROMs) using the Oxford Shoulder Scale or Oxford Shoulder Questionnaire. The Scale ranges from 0-48 with 48 indicating a satisfactory joint function score. A score of 30-39 indicated moderate to mild arthritis, a score of 20-29 indicates moderate to severe arthritis and a score of 0-19 indicates severe arthritis.

Trial Locations

Locations (2)

University of Buffalo; 🇺🇸 Buffalo, New York, United States

Norton Orthopaedic and Sports Medicine; 🇺🇸 Louisville, Kentucky, United States