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Tornier HRS (Humeral Reconstruction System) Study (REVIVE)

NCT05500066 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 110

Last updated 2026-03-30

No results posted yet for this study

Summary

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.

Conditions

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

Interventions

DEVICE

Tornier HRS (HUMERAL RECONSTRUCTION SYSTEM) shoulder system

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.

Sponsors & Collaborators

  • Stryker Trauma and Extremities

    lead INDUSTRY

Principal Investigators

  • Rebecca Gibson · Stryker Trauma and Extremities

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-11
Primary Completion
2028-01-06
Completion
2036-01-03
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05500066 on ClinicalTrials.gov