Phase
Condition
Bunion
Treatment
Products listed in Group/Cohort Description
Clinical Study ID
Ages > 2 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Subject requires surgery using Arthrex foot and ankle products included in theregistry.
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, whenapplicable, 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 anarthrodesis or arthroplasty of the 1st MTP. DualCompression Hindfoot Nail subjects only:
The participant must have instability, arthritis, rigid deformity, or severe foot orankle deformity necessitating tibiotalocalcaneal arthrodesis, commonly referred toas TTC arthrodesis.
The participant should be undergoing treatment with the Arthrex DualCompressionHindfoot Nail, either as a primary procedure or as a revision surgery, per standardof care
Exclusion
Exclusion Criteria:
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 restrictactivities 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 injuryor illness under any applicable occupational injury or disability program.
Subject has a planned or scheduled additional surgery on the affected orcontralateral lower extremity within the course of the study.
(® Nitinol Staple Subjects only):
Subjects who have a comminuted bone surface that would not allow for stapleplacement as required by the DynaNite® Nitinol Staples directions for use.
Subjects who have pathologic bone conditions such as osteopenia that would impairthe ability to securely fix the implant as required by the DynaNite® Nitinol Staplesdirections 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 wouldrequire 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 defectand aid in limb salvage
Study Design
Study Description
Connect with a study center
OrthoPedes
Duisburg, 47169
GermanyActive - Recruiting
Dr Haroun Mahomed Orthopaedic Practice
Durban, 3629
South AfricaActive - Recruiting
Life Westville Hospital
Durban, 3629
South AfricaSite Not Available
UC Davis Medical Center
Sacramento, California 95817
United StatesActive - Recruiting
TOA Research Foundation
Nashville, Tennessee 37209
United StatesTerminated
Barrett Podiatry
San Antonio, Texas 78258
United StatesTerminated
Atlantic Orthopaedic Specialists
Virginia Beach, Virginia 23462
United StatesActive - Recruiting
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