A Multi-Center, Prospective Registry to Evaluate the Continued Safety and Performance of the Foot and Ankle Products
Arthrex, Inc.
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.
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 postoperative…
Eligibility
- Age range
- 2+ years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: 1. Subject requires surgery using Arthrex foot and ankle products included in the registry. 2. Subject is 18 years of age or over (all products except ProStop®). 3. Subject age \>two to 17 years (ProStop® product only). 4. Capable of completing self-administered questionnaires. 5. Willing and able to return for all study-related follow-up visits. 6. 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): 7. Degenerative or post-traumatic arthriti…
Interventions
- DeviceProducts listed in Group/Cohort Description
Depending on approved indication per product
Locations (7)
- UC Davis Medical CenterSacramento, California
- Northwestern UniversityChicago, Illinois
- TOA Research FoundationNashville, Tennessee
- Barrett PodiatrySan Antonio, Texas
- Atlantic Orthopaedic SpecialistsVirginia Beach, Virginia
- OrthoPedesDuisburg