A Pilot Clinical Study to Evidence Safety and Efficacy of Fracture Fixation of the Distal Radius Using a Bioresorbable Bone Adhesive to Augment Metal Hardware

Обзор

A prospective, multi-center (up to 4 sites), single-arm, study of 20 subjects. Patient enrollment will consist of subjects with an AO/OTA type 2R3C distal radius fracture. Enrollment will be prospectively stratified based on patient age (Stratum A: \<65 and Stratum B: ≥65 years)

Подробное описание

The proposed study design is prospective, multi-center, single-arm, and non-randomized. RevBio is working to establish up to four (4) clinical sites. RevBio will perform site initiation visits to provide training to the investigator and its staff. Training will include information about study-specific procedures, a detailed review of the study protocol, instruction in completion of the electronic case report forms (eCRFs), informing the site about device instructions for use, and discussion of the regulatory requirements of the investigator. Patients will be recruited from the general patient population based on inclusion/exclusion criteria. Once they sign the informed consent form and complete the screening process they will be enrolled in the study and scheduled for surgery. All data will be reported to the FDA to evidence safety and efficacy and substantiate advancing to future stages in a larger expanded study.

Вмешательства

• Комбинированный продукт Augmented with Tetranite Bone Adhesive
  Participants will receive typical standard of care treatment for AO/OTA type 2R3C distal radius fractures augmented with tetranite bone adhesive.

Первичные конечные точки

• Safety based on the rate of serious device related adverse events [Срок оценки: For 52 weeks following surgery]
• Efficacy based on the fracture union assessment at the 26-week follow-up [Срок оценки: 26 weeks]
• Efficacy based on the DASH assessment at the 26-week timepoint [Срок оценки: 26 weeks]

Вторичные конечные точки (7)

• Grip strength compared to baseline (contralateral limb) [Срок оценки: 6 weeks post surgery to 52 weeks post surgery]
• Range of motion compared to baseline (contralateral limb) [Срок оценки: 2 weeks post surgery to 52 weeks post surgery]
• Patient reported outcome measure: SF-36 [Срок оценки: 2 weeks post surgery to 52 weeks post surgery]
• Patient reported outcome measure: DASH [Срок оценки: 2 weeks post surgery to 52 weeks post surgery]
• Patient reported outcome measure: VAS Pain Score [Срок оценки: 2 weeks post surgery to 52 weeks post surgery]
• Maintenance of reduction compared to baseline (surgery) [Срок оценки: Surgery]
• Fracture union assessment at the 6-,12-week follow-ups [Срок оценки: 6-,12-week follow-ups]

Критерии участия

Критерии включения

• Unilateral, unstable and/or displaced distal radius AO/OTA type 2R3C fracture.
• Standard treatment would consist of open reduction internal fixation (ORIF) with plate(s) and screws using a volar approach
• Surgical visit occurs within 2 weeks of injury.
• No radiographic evidence of fracture healing prior to surgical treatment.
• Male or female, greater than 21 years of age
• Subject living independently and ambulatory at the time of injury.
• Subject, and/or subject's representatives are able and willing to provide informed consent and HIPAA authorization.
• Subject able and willing to meet all study requirements, including attending all post-index procedure assessment visits and radiological tests.

Intra-Operative Inclusion Criteria:

• No sign of active infection at the planned operative site.
• Surgeons will decide whether the fracture site is a good candidate for TN-MFF use once the site is open and they can visualize the bone and surrounding soft tissue.

Критерии исключения

• Significant ligamentous disruption requiring independent repair
• Other fractures of the carpal bones or injured limb (Note: an associated ulnar styloid fracture is not exclusionary)
• Pathological fracture related to an underlying malignancy
• Open fractures
• A previous fracture in the injured bone within the last 12 months
• Presence of other orthopaedic implant in the injured bone
• Patients with presumptive diagnosis of named nerve or blood vessel injury
• Current infection (either superficial or deep) at the planned operative site
• Sepsis within one week from the planned index procedure
• History of radiotherapy to the area
• Active chemotherapy treatment
• Patients receiving treatment with biologics for systemic inflammatory disease (e.g., Enbrel)
• Physically or mentally compromised and unable to provide consent or perform functional examinations
• Subject has a condition with anticipated survival shorter than 12 months

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

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07452536 · DVAL24003 · SB1AG085803

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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