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

NCT04715139 | Recruiting FDA Device

• 1 other identifier: AIRR-0006
• Study Type: observational
• Target: 700
• Locations: 3 countries
• Sites: 7

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.

Conditions

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; Hyperpronated Foot

Outcome Measures

Primary Outcomes (4)

• To assess change in Visual Analogue Scale (VAS) survey

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

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

• 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)

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

• 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

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

• 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.

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

Study Arms (1)

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

Device: Products listed in Group/Cohort Description

Interventions

Products listed in Group/Cohort Description DEVICE

Depending on approved indication per product

All Products listed in Descriptions

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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 4.
• Subjects who require surgical intervention or are medically indicated for an arthrodesis or arthroplasty of the 1st MTP.
• DualCompression Hindfoot Nail subjects only:
• The participant must have instability, arthritis, rigid deformity, or severe foot or ankle deformity necessitating tibiotalocalcaneal arthrodesis, commonly referred to as TTC arthrodesis.
• The participant should be undergoing treatment with the Arthrex DualCompression Hindfoot Nail, either as a primary procedure or as a revision surgery, per standard of care

You may not qualify if:

• 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.
• (® Nitinol Staple Subjects only):
• Subjects who have a comminuted bone surface that would not allow for staple placement as required by the DynaNite® Nitinol Staples directions for use.
• Subjects who have pathologic bone conditions such as osteopenia that would impair the ability to securely fix the implant as required by the DynaNite® Nitinol Staples directions for use.
• (ArthroFLEX® subjects only):
• Additional ipsilateral lower limb pathology that requires active treatment.

Sponsors & Collaborators

• Arthrex, Inc.: lead

Study Sites (7)

UC Davis Medical Center

Sacramento, California, 95817, United States

RECRUITING

Northwestern University

Chicago, Illinois, 60611, United States

RECRUITING

TOA Research Foundation

Nashville, Tennessee, 37209, United States

TERMINATED

Barrett Podiatry

San Antonio, Texas, 78258, United States

TERMINATED

Atlantic Orthopaedic Specialists

Virginia Beach, Virginia, 23462, United States

RECRUITING

OrthoPedes

Duisburg, 47169, Germany

TERMINATED

Dr Haroun Mahomed Orthopaedic Practice

Durban, 3629, South Africa

TERMINATED

Central Study Contacts

Justin Moss, DHSc

CONTACT

770 584 4972; justin.moss@arthrex.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2021
• First Posted: January 20, 2021
• Study Start: December 1, 2020
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 11, 2026

Record last verified: 2025-06

Locations

US (5); DE (1); ZA (1)