Zimmer Biomet Shoulder Arthroplasty PMCF

Part of paid clinical trials in Irvine, California.

Sponsor
Zimmer Biomet
Study ID
NCT04984291
Status
Recruiting
Apply to this trial

Conditions

  • Shoulder Arthritis
  • Shoulder Deformity
  • Shoulder Fractures
  • Shoulder Injuries
  • Shoulder Osteoarthritis
  • Shoulder Pain

Eligibility Criteria

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

Interventions

  • Alliance Glenoid — DEVICE
    Alliance Glenoid used in Primary or Revision Total Shoulder Arthroplasty
  • Identity Stem — DEVICE
    Identity Shoulder System is intended to be used in anatomic total shoulder arthroplasty, shoulder hemi-arthroplasty, or total reverse shoulder arthroplasty in both Primary or Revision Total Shoulder Arthroplasty

Study Details

The objectives of this study are to confirm the safety, performance, and clinical benefits of Zimmer Biomet Shoulder Arthroplasty Systems and its instrumentation in primary or revision shoulder arthroplasty. These objectives will be assessed using standard scoring systems, radiographic evidence, and adverse event records. Safety of the system will be assessed by monitoring the frequency an incidence of adverse events.

Key Dates

Start date
Jul 28, 2021
Status verified
Apr 2026
Primary completion
Aug 15, 2033
Completion
Aug 15, 2033

Study Design

Enrollment
584 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Zimmer Biomet Total Shoulder Arthroplasty System
    Patients who are having primary or revision total shoulder arthroplasty who will receive a Zimmer Biomet Total Shoulder Arthroplasty System.

Primary Outcome Measure

Implant Survivorship at 10 years follow-up (Kaplan Meier) [ Time Frame: 10 years ]

Central Contacts

Locations (12)

FacilityCityStateZIPSite coordinators
Hoag Orthopedic InstituteIrvineCalifornia92618-
Panorama Orthopaedic and Spine CenterGoldenColorado80401
Paul Lee, PA
[email protected]
720-497-6697
[email protected]
David Schneider, MD (PRINCIPAL_INVESTIGATOR)
James Johnson, MD (SUB_INVESTIGATOR)
Northwestern UniversityChicagoIllinois60208-
Norton Healthcare, IncLouisvilleKentucky40202-
William Beaumont HospitalRoyal OakMichigan48073-
TRIA Orthopaedic Center Research InstituteBloomingtonMinnesota55431-
Mississippi Sports Medicine and Orthopaedic Center, PLLCJacksonMississippi39202-
Advance Bone and JointCity of Saint PetersMissouri63376-
Washington UniversitySt LouisMissouri63130-
University of BuffaloBuffaloNew York14215-
Rothman InstitutePhiladelphiaPennsylvania19107-
Intermountain HealthMurrayUtah84107
Maha Maleki, BS
[email protected]
801-507-8095
Matt Schneider, MS
[email protected]
801-507-8095
Aaron Chamberlain, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Irvine, CA

By research site
Hoag Orthopedic Institute· Irvine, CAPanorama Orthopaedic and Spine Center· Golden, CONorthwestern University· Chicago, ILNorton Healthcare, Inc· Louisville, KYWilliam Beaumont Hospital· Royal Oak, MITRIA Orthopaedic Center Research Institute· Bloomington, MN

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