A Multi-Center, Prospective Registry to Evaluate the Continued Safety and Performance of the Foot and Ankle Products
Overview
- Phase
- N/A
- Intervention
- Products listed in Group/Cohort Description
- Conditions
- Not specified
- Sponsor
- Arthrex, Inc.
- Enrollment
- 700
- Locations
- 7
- Primary Endpoint
- To assess change in Visual Analogue Scale (VAS) survey
- Status
- Recruiting
- Last Updated
- 2 months ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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:
Exclusion Criteria
- •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.
Arms & Interventions
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
Intervention: Products listed in Group/Cohort Description
Outcomes
Primary Outcomes
To assess change in Visual Analogue Scale (VAS) survey
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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.