DenCT Shoulder Bone Quality Evaluation

Официальное название

Collection of CT Images to Evaluate Bone Quality Before Total Shoulder Arthroplasty

Обзор

The objective of the study is to evaluate the preoperative bone quality assessment based on CT to later establish a scale for the decision of stemless shoulder arthroplasty.

Подробное описание

The primary endpoint is the collection of the preoperative CT scan with a calibration phantom at each site and the surgeon's intraoperative evaluation of bone quality. Therefore, this study is not centered around a specific device and any primary shoulder arthroplasty system from Zimmer Biomet including anatomical, hemi, or reverse, stemmed or stemless configurations can be used for the target population. The indications of this study are the shoulder joint diseases such as osteoarthritis and the irreparable rotator cuff tears which are needed with TSA/RSA. The subjects should be also met the inclusion/exclusion criteria. The safety of the system will be assessed by monitoring the frequency and incidence of adverse events.

Вмешательства

• Лучевая терапия Preoperative CT Scan
  Preoperative CT Scan including a bone density calibration phantom. This data will be compared with surgeon intra-operative CRF responses.

Первичные конечные точки

• CT scan data acquisition [Срок оценки: Immediate post-op]
• Intra-op bone quality evaluation: Thumb Test [Срок оценки: Intra-op]
• Intra-op bone quality evaluation: Pin Test [Срок оценки: Intra-op]
• Intra-op bone quality evaluation: Broach Test [Срок оценки: Intra-op]
• Duplicate CT scan data acquisition (Optional) [Срок оценки: Immediate post-op]

Критерии участия

Критерии включения

• Patient must be older than 18 years and skeletally mature.
• Patient must undergo the SHA, TSA, or RSA according to the Instructions for Use (IFU).
• Patient must be anatomically and structurally suited to receive shoulder arthroplasty implants.
• Patient is a candidate for lateral or bi-lateral shoulder arthroplasty due to one or more of the following:
• Non-inflammatory degenerative joint disease including osteoarthritis.
• Avascular necrosis of the humeral head.
• Autoimmune disease including rheumatoid arthritis.
• Irreparable rotator cuff tears.
• Correction of functional deformity.
• Patient must be able and willing to sign the IRB/EC approved informed consent.
• Patient must be able to undergo a preoperative CT scan
• Patient must be willing to share their CT images with sponsor

Критерии исключения

• Patient is a candidate for shoulder arthroplasty due to one or more of the following:
• Fractures of the proximal humerus, where other methods of treatment are deemed inadequate.
• Revision TSA/RSA after the prior TSA/RSA.
• Patient has experienced the traumatic fractures to the implant site.
• Patient is unwilling or unable to give consent
• Patient has any condition which would in the judgement of the Investigator, place the patient at undue risk or interfere with the study, e.g., any neuromuscular disease compromising the affected limb.
• Patient is known to be pregnant or breastfeeding.
• Patient is a vulnerable subject (prisoner, mentally incompetent or unable to understand what participation to the study entails, a known alcohol or drug abuser, and/or anticipated to be non- compliant).
• Patient is uncooperative or patient with neurologic disorders who is incapable or unwilling to follow directions.
• Patient has any sign of infection affecting the shoulder joint or in its proximity which may spread to the implant site.
• Patient has rapid joint destruction, marked bone loss, or bone resorption apparent on roentgenogram.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Фундаментальное исследование

Центры проведения

Япония · 1 центр

• Joint Surgery, Sports Clinic Ishinomaki — Ishinomaki

Идентификаторы

NCT: NCT06032416 · CSG2023-05E

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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