Status:
RECRUITING
Evaluate the Continued Safety and Performance of the Foot and Ankle Products
Lead Sponsor:
Arthrex, Inc.
Conditions:
Hyperpronated Foot
Reconstruction Surgeries of the Foot
Eligibility:
All Genders
2+ years
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 r...
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 w...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
- Bilateral degenerative or post-traumatic arthritis of the 1st MTP joints that would require simultaneous treatment of both MTP joints.
- Diagnosis of gout.
- Any significant bone loss, avascular necrosis, and/or large osteochondral cyst (\>1cm) of the 1st MTP joint.
- Lesions greater than 10mm in size.
- Hallux varus to any degree, or hallux valgus \>20 degrees.
- (DualCompression Hindfoot Nail subjects only):
- Requiring only a tibiotalar or subtalar arthrodesis
- Patient requires bulk allograft or metal spacer implant to fill large bony defect and aid in limb salvage
Key Trial Info
Start Date :
December 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
700 Patients enrolled
Trial Details
Trial ID
NCT04715139
Start Date
December 1 2020
End Date
December 31 2027
Last Update
June 26 2025
Active Locations (6)
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1
UC Davis Medical Center
Sacramento, California, United States, 95817
2
TOA Research Foundation
Nashville, Tennessee, United States, 37209
3
Barrett Podiatry
San Antonio, Texas, United States, 78258
4
Atlantic Orthopaedic Specialists
Virginia Beach, Virginia, United States, 23462