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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 主要终点
- Safety based on the rate of serious device related adverse events
研究概览
简要总结
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)
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Augmented with Tetranite Bone Adhesive
Participants will receive typical standard of care treatment for AO/OTA type 2R3C distal radius fracture augmented with tetranite bone adhesive.
干预措施: Augmented with Tetranite Bone Adhesive (Combination Product)
结局指标
主要结局
Safety based on the rate of serious device related adverse events
时间窗: For 52 weeks following surgery
Safety based on the rate of serious device related adverse events
Efficacy based on the fracture union assessment at the 26-week follow-up
时间窗: 26 weeks
Fracture union assessment at the 26-week follow-up
Efficacy based on the DASH assessment at the 26-week timepoint
时间窗: 26 weeks
DASH assessment at the 26-week timepoint
次要结局
- Grip strength compared to baseline (contralateral limb)(6 weeks post surgery to 52 weeks post surgery)
- Range of motion compared to baseline (contralateral limb)(2 weeks post surgery to 52 weeks post surgery)
- Patient reported outcome measure: SF-36(2 weeks post surgery to 52 weeks post surgery)
- Patient reported outcome measure: DASH(2 weeks post surgery to 52 weeks post surgery)
- Patient reported outcome measure: VAS Pain Score(2 weeks post surgery to 52 weeks post surgery)
- Maintenance of reduction compared to baseline (surgery)(Surgery)
- Fracture union assessment at the 6-,12-week follow-ups(6-,12-week follow-ups)