Trials / Recruiting
RecruitingNCT04715139
Evaluate the Continued Safety and Performance of the Foot and Ankle Products
A Multi-Center, Prospective Registry to Evaluate the Continued Safety and Performance of the Foot and Ankle Products
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 700 (estimated)
- Sponsor
- Arthrex, Inc. · Industry
- Sex
- All
- Age
- 2 Years
- Healthy volunteers
- Accepted
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.
Conditions
- Hyperpronated Foot
- Reconstruction Surgeries of the Foot
- Fixation of Fractures and Fusion (Bunionectomy Osteotomies) of the Foot/Ankle
- Fixation of Small Bone Fragments of the Foot/Ankle
- Lisfranc Arthrodesis
- Mono or Bi-cortical Osteotomies in the Forefoot
- First Metatarsophalangeal Arthrodesis
- Akin Osteotomy
- Midfoot and Hindfoot Arthrodeses or Osteotomies
- Fixation of Osteotomies for Hallux Valgus Treatment (Scarf and Chevron)
- Arthrodesis of the Metatarsocuneiform Joint to Reposition and Stabilize Metatarsus Primus Varus
- Osteotomy Fixation of Hallux Valgus Repair (Such as Scarf and Chevron Etc.)
- Medial Ankle Stabilization
- Tibiotalocalcaneal Arthrodesis
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Products listed in Group/Cohort Description | Depending on approved indication per product |
Timeline
- Start date
- 2020-12-01
- Primary completion
- 2027-12-01
- Completion
- 2027-12-31
- First posted
- 2021-01-20
- Last updated
- 2026-02-11
Locations
7 sites across 3 countries: United States, Germany, South Africa
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04715139. Inclusion in this directory is not an endorsement.