A Multi-Center, Prospective Registry to Evaluate the Continued Safety and Performance of the Foot and Ankle Products
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 700
- 试验地点
- 7
- 主要终点
- To assess change in Visual Analogue Scale (VAS) survey
研究概览
简要总结
The objective of the registry is to evaluate the continued safety and performance of Arthrex foot and ankle products, including the ProStop® implant for hyperpronated foot; Bio-Compression Screw for reconstruction surgeries of the foot; TRIM-IT Drill Pin® system and/or TRIM-IT Spin Pin™ system for fixation of fractures and fusion (bunionectomy osteotomies) of the foot/ankle; Headless Compression Screws and Compression FT Screws for fixation of small bone fragments of the foot/ankle; DynaNite® nitinol staple for midfoot and hindfoot arthrodeses or osteotomies, first metatarsophalangeal arthrodesis, and mono or bi-cortical osteotomies in the forefoot; BioComposite SutureTak® anchor for medial ankle stabilization; Beveled FT Screws for hallux valgus repair; KreuLock™ screws for ankle fractures; ArthroFLEX® dermal allograft for hallux rigidus arthroplasty; and DualCompression Hindfoot Nail for tibiotalocalcaneal arthrodesis.
详细描述
Device-related adverse events will be continuously assessed and summarized at three months, six months, one year, and two years postoperatively to evaluate safety. A physical exam of the target area will be conducted three months postoperatively to evaluate performance. Range of motion (ROM) will be assessed preoperatively, at three months, six months, and one year postoperatively for the ArthroFLEX® dermal allograft only. Patient-reported outcomes (PROs) will be evaluated for all products at three months, six months, and one year. Additionally, PROs will be assessed at two years postoperatively for ArthroFLEX® dermal allograft and DualCompression Hindfoot Nail only. PROs include the Foot and Ankle Ability Measures (FAAM), Visual Analogue Scale (VAS), Single Assessment Numeric Evaluation (SANE) score, and Veterans Rand 12-Item Health Survey (VR-12). DualCompression X-rays will be evaluated at six months and one year postoperatively for ArthroFLEX® dermal allograft and DualCompression Hindfoot Nail only, and CT scans will be assessed at three months postoperatively for DualCompression Hindfoot Nail only.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject requires surgery using Arthrex foot and ankle products included in the registry.
- •Subject is 18 years of age or over (all products except ProStop®).
- •Subject age >two to 17 years (ProStop® product only).
- •Capable of completing self-administered questionnaires.
- •Willing and able to return for all study-related follow-up visits.
- •Subject or subject's representative signed informed consent and assent, when applicable, and is willing and able to comply with all study requirements.
- •(ArthroFLEX® subjects only):
- •Degenerative or post-traumatic arthritis of the 1st MTP joint with grade 2, 3, or
- •Subjects who require surgical intervention or are medically indicated for an arthrodesis or arthroplasty of the 1st MTP.
- •DualCompression Hindfoot Nail subjects only:
- •The participant must have instability, arthritis, rigid deformity, or severe foot or ankle deformity necessitating tibiotalocalcaneal arthrodesis, commonly referred to as TTC arthrodesis.
- •The participant should be undergoing treatment with the Arthrex DualCompression Hindfoot Nail, either as a primary procedure or as a revision surgery, per standard of care
排除标准
- •Insufficient quantity or quality of bone.
- •Blood supply limitations and previous infections, which may retard healing.
- •Foreign-body sensitivity.
- •Any active infection or blood supply limitations.
- •Conditions that tend to limit the patient's ability or willingness to restrict activities or follow directions during the healing period.
- •Subjects that are skeletally immature (except for ProStop®).
- •Subject is considered from vulnerable population (i.e., child, prisoner, pregnant).
- •Subjects who are contraindicated for these devices.
- •Subject is currently receiving compensation or benefits due to a work-related injury or illness under any applicable occupational injury or disability program.
- •Subject has a planned or scheduled additional surgery on the affected or contralateral lower extremity within the course of the study.
- •(® Nitinol Staple Subjects only):
- •Subjects who have a comminuted bone surface that would not allow for staple placement as required by the DynaNite® Nitinol Staples directions for use.
- •Subjects who have pathologic bone conditions such as osteopenia that would impair the ability to securely fix the implant as required by the DynaNite® Nitinol Staples directions for use.
- •(ArthroFLEX® subjects only):
- •Additional ipsilateral lower limb pathology that requires active treatment.
- •Bilateral degenerative or post-traumatic arthritis of the 1st MTP joints that would require simultaneous treatment of both MTP joints.
- •Diagnosis of gout.
- •Any significant bone loss, avascular necrosis, and/or large osteochondral cyst (>1cm) of the 1st MTP joint.
- •Lesions greater than 10mm in size.
- •Hallux varus to any degree, or hallux valgus >20 degrees.
- •(DualCompression Hindfoot Nail subjects only):
- •Requiring only a tibiotalar or subtalar arthrodesis
- •Patient requires bulk allograft or metal spacer implant to fill large bony defect and aid in limb salvage
研究组 & 干预措施
All Products listed in Descriptions
- ProStop
- BioCompression Screw
- TRIM-IT Drill Pin/TRIM-IT Spin Pin
- Headless Compression Screw/Compression FT Screw
- DynaNite Nitinol Staple
- BioComposite SutureTak Anchor
- Beveled Headed FT Screw
- KreuLock Screws
- ArthroFLEX dermal allograft
- DualCompression Hindfoot Nail
干预措施: Products listed in Group/Cohort Description (Device)
结局指标
主要结局
To assess change in Visual Analogue Scale (VAS) survey
时间窗: preoperatively, 3 months, 6 months and 12 months post operative
Patient reported pain scale 0-10 point scale (0 min, 10 max)
To assess changes in Veterans RAND Health (VR-12) survey
时间窗: preoperatively, 3 months, 6 months and 12 months post operative
Patient reported changes in general health and mental survey. Average score is 50 (negative answers bring scores down, positive answers bring score up)
To assess changes in Foot and Ankle Ability Measures (FAAM) survey
时间窗: preoperatively, 3 months, 6 months and 12 months post operative
Patient reported change to physical function for individuals with foot and ankle related impairments. A higher score represents a higher level of physical function
To assess change in Single Assessment Numeric Evaluation (SANE) survey
时间窗: preoperatively, 3 months, 6 months and 12 months post operative
Patient reported change to affected body part on a scale from 0 to 100, with 100 representing their normal function.
次要结局
未报告次要终点