Tornier HRS (Humeral Reconstruction System) Study (REVIVE)

Part of paid clinical trials in Denver, Colorado.

Sponsor
Stryker Trauma and Extremities
Study ID
NCT05500066
Status
Enrolling By Invitation

Conditions

  • Avascular Necrosis
  • Correction of Functional Deformity
  • Fractures Humerus
  • Osteoarthritis Shoulder
  • Revision of Other Devices if Sufficient Bone Stock Remains
  • Rheumatoid Arthritis
  • Rotator Cuff Tears
  • Traumatic Arthritis

Eligibility Criteria

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

Interventions

  • Tornier HRS (HUMERAL RECONSTRUCTION SYSTEM) shoulder system — DEVICE
    Tornier HRS (HUMERAL RECONSTRUCTION SYSTEM) shoulder system is intended for use as: * A replacement of shoulder joints in primary anatomic or in primary reverse * A replacement of other shoulder joints devices in case of revisions if sufficient bone stock remains. The system also allows for conversion from anatomic to reverse shoulder prosthesis in case of revision.

Study Details

This is an international, single arm, multicenter, prospective follow-up, non-significant risk, Post-Market Clinical Follow-up (PMCF) study. Data will be collected for the commercially available Tornier HRS (HUMERAL RECONSTRUCTION SYSTEM) shoulder system in both the anatomic and reversed configurations. Retrospective inclusions are allowed: study patients may be enrolled up to 3 months after date of surgery provided that the necessary pre-operative (baseline) and surgery data are accessible. Follow-up visits conducted from 3-month post-surgery onward must be prospective. The purpose of this study is to collect data needed to satisfy the European Union (EU) Medical Device Regulation (MDR) clinical post-market surveillance (PMS) and reporting requirements, and to support future regulatory submissions and peer-reviewed publications on device performance and safety.

Key Dates

Start date
Jan 11, 2023
Status verified
Mar 2026
Primary completion
Jan 6, 2028
Completion
Jan 3, 2036

Study Design

Enrollment
110 participants (estimated)

Arms

  • Arm: Tornier HRS (HUMERAL RECONSTRUCTION SYSTEM) shoulder system
    Commercially available shoulder system available in both anatomic and reversed configurations.

Primary Outcome Measure

Average Improvement from Baseline to last follow-up visit in ASES Score [ Time Frame: 24 Month ]

Locations (4)

FacilityCityStateZIPSite coordinators
HCA Healthcare Research InstituteDenverColorado80222-
Coastal OrthopedicsBradentonFlorida34212-
Foundation for Orthopaedic Research & EducationTampaFlorida33637-
Baptist Health LexingtonLexingtonKentucky40503-

Find similar trials in Denver, CO

By condition
Rheumatoid arthritis
By specialty
RheumatologyAutoimmune diseaseMusculoskeletal disorders
By research site
HCA Healthcare Research Institute· Denver, COCoastal Orthopedics· Bradenton, FLFoundation for Orthopaedic Research & Education· Tampa, FLBaptist Health Lexington· Lexington, KY

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