MDR - Comprehensive Reverse/Versa Dial Ti Glenosphere

Part of paid clinical trials in Louisville, Kentucky.

Sponsor
Zimmer Biomet
Study ID
NCT04003272
Status
Enrolling By Invitation

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Oct 28, 2019
Status verified
Feb 2026
Primary completion
Aug 19, 2034
Completion
Sep 1, 2035

Study Design

Enrollment
59 participants (estimated)

Arms

  • Arm: 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 Measure

Product Safety assessed through the incidence and frequency of revisions, complications and adverse events [ Time Frame: Out to 10 years ]

Locations (2)

FacilityCityStateZIPSite coordinators
Norton Orthopaedic and Sports MedicineLouisvilleKentucky40241-
University of BuffaloBuffaloNew York14215-

Find similar trials in Louisville, KY

By research site
Norton Orthopaedic and Sports Medicine· Louisville, KYUniversity of Buffalo· Buffalo, NY

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