MDR - Comprehensive Reverse/Versa Dial Ti Glenosphere

Shoulder Pain Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04003272
• Other study ID #: MDRG2017-89MS-40E
• Status: Enrolling by invitation
• Start date: October 28, 2019
• Est. completion date: July 29, 2029

Study information

• Verified date: May 2024
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 73
• Est. completion date: July 29, 2029
• Est. primary completion date: July 29, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Shoulder Arthritis
• Shoulder Disease
• Shoulder Fractures
• Shoulder Injuries
• Shoulder Pain

Intervention

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

Locations

Country	Name	City	State
United States	Norton Orthopaedic and Sports Medicine	Louisville	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Product Clinical Benefits and Performance evaluated through the Oxford Shoulder Scale OSS or Oxford Shoulder Questionnaire.	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.	Out to10 years
Secondary	Product Clinical Benefits and Performance evaluated through the Patient Assessment Questionnaire	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).	Out to 10 years