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Enrolling by Invitation

NCT Number: NCT05500066

Tornier HRS (Humeral Reconstruction System) Study (REVIVE)

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.

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Key information

Conditions

Rheumatoid Arthritis Arm Injuries Arthritis Arthritis, Rheumatoid Autoimmune Diseases Avascular Necrosis Bone Diseases Connective Tissue Diseases Correction of Functional Deformity Fractures Humerus Fractures, Bone Humeral Fractures Immune System Diseases Joint Diseases Musculoskeletal Diseases Necrosis Osteoarthritis Osteoarthritis Shoulder Osteonecrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Revision of Other Devices if Sufficient Bone Stock Remains Rheumatic Diseases Rotator Cuff Injuries Rotator Cuff Tears Rupture Shoulder Injuries Skin and Connective Tissue Diseases Tendon Injuries Traumatic Arthritis Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

HCA Healthcare Research Institute, Denver, Colorado, United States

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About this study

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 primary outcome measure will be measured by the average improvement in American Shoulder and Elbow Surgeons (ASES) score from baseline to 24 months.

Secondary outcome measures include patient reported outcome measures (PROMs) and standard radiographic findings, including, but not limited to: device migration, component breakage, and bone characteristics.

Device revision and adverse events (AEs) will be assessed annually throughout the study. Range of motion and radiographic imaging assessments will also be performed at Years 1, 2, 5 and 10 post-operation.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years or older at the time of the informed consent.
  • Informed and willing to sign an informed consent form approved by IRB or Ethics Committee (EC) (when applicable).
  • Willing and able to comply with the requirements of the study protocol.
  • Considered for a candidate for shoulder arthroplasty using the study device
  • Meets indications for use requirements or other local, regional, or geographic specific regulatory requirements

Exclusion criteria

  • Not able to comply with the study procedures based on the judgment of the assessor (e.g., cannot comprehend study questions, inability to keep scheduled assessment times)
  • Patient belongs to a vulnerable group of patients, including minor patients, those unable to decide for themselves to participate or needing a Legally Authorized Representative (LAR), or others who could be subject to coercion (patients who may not be acting on their own initiative) (referred as "vulnerable subject" in the section 3.44 of the ISO 14155 norm).
  • Active local or systemic infection, sepsis, or osteomyelitis
  • Poor bone quality, where there could be considerable migration of the prothesis and/or a chance of fracture of the humerus or glenoid (reassessed at time of surgery)
  • Significant injury to the brachial plexus
  • Inadequate bone stock in the proximal humerus or glenoid fossa for supporting the components
  • Neuromuscular disease (e.g., joint neuropathy)
  • Patient with known allergy to one of the product materials
  • Metabolic disorders which may impair bone formation
  • Patient pregnancy
  • Planned for two-stage surgery (reassessed at time of surgery)

Treatment and study plan

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.

Primary outcomes

  1. Average Improvement from Baseline to last follow-up visit in ASES Score

    Time frame: 24 Month

    ASES Score = American Shoulder and Elbow Surgeons Score, 11 items with total score reported out of 100 measuring pain and activity of patient's evaluated shoulder where lower scores indicate more pain and less function

Secondary outcomes

  1. Constant Score

    Time frame: through study completion, an average of 1 year

    A score based on a 100-point scale determined by objective measurements made by the physician in the clinic and subjective values based on pain and activities of daily living reported by the patient.

  2. SANE

    Time frame: through study completion, an average of 1 year

    Single question that asks the patient to rate their shoulder on a scale from 0 to 100, where 100 is normal.

  3. EQ 5-D

    Time frame: through study completion, an average of 1 year

    Consists of a 5-question measure where patients rate their health today on a 5-point scale on a 5-dimension scale and a visual analogue scale to measure overall health status.

  4. Patient Satisfaction

    Time frame: through study completion, an average of 1 year

    Single subjective question "How satisfied are you with your shoulder?"

  5. Radiographic Findings

    Time frame: Baseline, 1 year, 2 year, 5 year and 10 year

    Images will be reviewed by a single orthopedic surgeon to assess for standard radiographic findings, including, but not limited to: device migration, component breakage, and bone characteristics.

Sponsors and collaborators

Lead sponsor

Stryker Trauma and Extremities

Industry

Registry information

Acronym: REVIVE

Important dates

Study start
2023
Primary completion
2028
Study completion
2036
First posted
Aug 12, 2022
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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