Perform Humeral System Study

Part of paid clinical trials in Lexington, Kentucky.

Sponsor
Stryker Trauma and Extremities
Study ID
NCT05067543
Status
Recruiting
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Conditions

  • Avascular Necrosis
  • Osteoarthritis Shoulder
  • Post-traumatic Arthrosis of Other Joints, Shoulder Region
  • Rotator Cuff Tear Arthropathy

Eligibility Criteria

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

Interventions

  • Tornier Perform Humeral - Stem — DEVICE
    The PERFORM Humeral System - Stem is a non-constrained prosthesis intended for the total or partial replacement of the glenohumeral articulation.

Study Details

This study is an international, single arm, multicenter, prospective, non-significant risk, Post-Market Clinical Follow-up study, which is designed to collect safety and performance data at baseline, surgery, immediate post-op and annually through 10 years post-operation. Data collected from this study will be used for purposes, including but not limited to, Post-Market Surveillance, peer-reviewed publications, education materials, regulatory submissions, and/or product development.

Key Dates

First listed
Oct 5, 2021
Start date
Sep 12, 2021
Status verified
Feb 2026
Primary completion
Jun 30, 2036
Completion
Dec 1, 2036

Study Design

Enrollment
300 participants (estimated)

Arms

  • Arm: Tornier Perform Humeral System - Stem
    Partial or total shoulder arthroplasty using the Tornier Perform Humeral Stem.

Primary Outcome Measure

Change from Baseline to last follow-up visit in ASES scores [ Time Frame: Baseline through Follow-Up visits through 24 months Post-Op ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
Baptist HealthcareLexingtonKentucky40503
Johnetta Comello
[email protected]
Brent Morris (PRINCIPAL_INVESTIGATOR)
Summit OrthopedicsEaganMinnesota55121
Michael Freehill, MD (PRINCIPAL_INVESTIGATOR)
Mayo ClinicRochesterMinnesota55905-
Washington UniversitySt LouisMissouri63110-
Orthopedic InstituteSioux FallsSouth Dakota57105
Keith Baumgarten, MD (PRINCIPAL_INVESTIGATOR)
University of UtahSalt Lake CityUtah84108
Ashley Neese
[email protected]
Robert Tashjian (SUB_INVESTIGATOR)
Christopher Joyce (PRINCIPAL_INVESTIGATOR)

Find similar trials in Lexington, KY

By research site
Baptist Healthcare· Lexington, KYSummit Orthopedics· Eagan, MNMayo Clinic· Rochester, MNWashington University· St Louis, MOOrthopedic Institute· Sioux Falls, SDUniversity of Utah· Salt Lake City, UT

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