Health Trials

Evaluate the Continued Safety and Performance of the Foot and Ankle Products

ConditionsHyperpronated FootReconstruction Surgeries of the FootFixation of Fractures and Fusion (Bunionectomy Osteotomies) of the Foot/AnkleFixation of Small Bone Fragments of the Foot/AnkleLisfranc ArthrodesisMono or Bi-cortical Osteotomies in the ForefootFirst Metatarsophalangeal ArthrodesisAkin OsteotomyMidfoot and Hindfoot Arthrodeses or OsteotomiesFixation of Osteotomies for Hallux Valgus Treatment (Scarf and Chevron)Arthrodesis of the Metatarsocuneiform Joint to Reposition and Stabilize Metatarsus Primus VarusOsteotomy Fixation of Hallux Valgus Repair (Such as Scarf and Chevron Etc.)Medial Ankle StabilizationTibiotalocalcaneal Arthrodesis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age2+
SponsorArthrex, Inc.

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Products listed in Group/Cohort Description

Treatment groups

700 Participants
are divided into 1 treatment group

Sponsors and collaborators

Arthrex, Inc.

Lead sponsor

Source ClinicalTrials.gov