Health TrialsbyHealthPanel

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

This trial accepts healthy volunteers

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 population

Approximately 700 subjects (50 subjects per product/indication pair) will be enrolled. The subject population will be male and female,18 years of age or older, with the exception of ProStop®, which includes subjects aged \>2 to 17 years of age. Subjects will be recruited from the surgeon's patient population or referrals from other physicians.

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • Products listed in Group/Cohort Description

    Device

    Depending on approved indication per product

Treatment groups

700 Participants
are divided into 1 treatment group
Group A: All Products listed in Descriptions1 intervention

Trial outcomes

Primary outcomes

1

To assess change in Visual Analogue Scale (VAS) survey

Patient reported pain scale 0-10 point scale (0 min, 10 max)

Time frame
preoperatively, 3 months, 6 months and 12 months post operative
2

To assess changes in Veterans RAND Health (VR-12) survey

Patient reported changes in general health and mental survey. Average score is 50 (negative answers bring scores down, positive answers bring score up)

Time frame
preoperatively, 3 months, 6 months and 12 months post operative
3

To assess changes in Foot and Ankle Ability Measures (FAAM) survey

Patient reported change to physical function for individuals with foot and ankle related impairments. A higher score represents a higher level of physical function

Time frame
preoperatively, 3 months, 6 months and 12 months post operative
4

To assess change in Single Assessment Numeric Evaluation (SANE) survey

Patient reported change to affected body part on a scale from 0 to 100, with 100 representing their normal function.

Time frame
preoperatively, 3 months, 6 months and 12 months post operative

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Arthrex, Inc.

Lead sponsor

Source ClinicalTrials.gov
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