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

Study Overview
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Brief Summary
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The objective of the registry is to evaluate the continued safety and performance of the 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, TRIM-IT Spin Pin 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 and DynaNite® Nitinol Staple to be used for fixation such as 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), and arthrodesis of the metatarsocuneiform joint to reposition and stabilize metatarsus primus varus and Beveled Headed FT Screws for osteotomy fixation of Hallux valgus repair (such as Scarf and Chevron etc.)

Detailed Description
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To assess safety, related adverse events will be evaluated at six months postoperative and at one-year postoperative time points. To evaluate performance, physical exam and imaging of the target area of the body will be evaluated at three months postoperative. Additionally, patient reported outcomes will be evaluated at three months postoperative, six months postoperative and one year postoperative using the Visual Analogue Scale (VAS), Veterans Rand 12-Item Health Survey (VR-12) and Foot and Ankle Ability Measures (FAAM).

Official Title
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A Multi-Center, Prospective Registry to Evaluate the Continued Safety and Performance of the Foot and Ankle Products

Conditions
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Hyperpronated Foot, 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.)

Intervention / Treatment
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* Device: Products listed in Group/Cohort Description


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject requires surgery for treatment of hyperpronated foot using the Arthrex ProStop® implant Subject is 18 years of age or over (all products except ProStop) Subject age >two to 17 years (ProStop product only) Subject is not pregnant, nursing, prisoner, or ward of the state Subject or subject's representative signed informed consent and assent when, applicable, and is willing and able to comply with all study requirements 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 restrict activities or follow directions during the healing period Subjects that are skeletally immature (except for ProStop) (DynaNite 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

Ages Eligible for Study
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Minimum Age: 2 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All Products listed in Descriptions<br>ProStop BioCompression Screw TRIM-IT Drill Pin/TRIM-IT Spin Pin Headless Compression Screw/Compression FT Screw DynaNite Nitinol Staple Beveled Headed FT Screw | Device: Products listed in Group/Cohort Description<br>* Depending on approved indication per product<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |