Tornier HRS (Humeral Reconstruction System) Study (REVIVE)

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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.

Первичные конечные точки

• Average Improvement from Baseline to last follow-up visit in ASES Score [Срок оценки: 24 Month]

Вторичные конечные точки (5)

• Constant Score [Срок оценки: through study completion, an average of 1 year]
• SANE [Срок оценки: through study completion, an average of 1 year]
• EQ 5-D [Срок оценки: through study completion, an average of 1 year]
• Patient Satisfaction [Срок оценки: through study completion, an average of 1 year]
• Radiographic Findings [Срок оценки: Baseline, 1 year, 2 year, 5 year and 10 year]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 4 центра

• HCA Healthcare Research Institute — Denver
• Coastal Orthopedics — Bradenton
• Foundation for Orthopaedic Research & Education — Tampa
• Baptist Health Lexington — Lexington

Идентификаторы

NCT: NCT05500066 · 20F-W-REVIVE-RM

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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