Akin Osteotomy Clinical Trial
Official title:
A Multi-Center, Prospective Registry to Evaluate the Continued Safety and Performance of the Foot and Ankle Products
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.)
| Status | Recruiting |
| Enrollment | 650 |
| Est. completion date | December 31, 2024 |
| Est. primary completion date | December 1, 2024 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 2 Years and older |
| Eligibility | Inclusion Criteria: 1. Subject requires surgery for treatment of hyperpronated foot using the Arthrex ProStop® implant 2. Subject is 18 years of age or over (all products except ProStop) 3. Subject age >two to 17 years (ProStop product only) 4. Subject is not pregnant, nursing, prisoner, or ward of the state 5. 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: 1. Insufficient quantity or quality of bone 2. Blood supply limitations and previous infections, which may retard healing 3. Foreign-body sensitivity 4. Any active infection or blood supply limitations 5. Conditions that tend to limit the patient's ability or willingness to restrict activities or follow directions during the healing period 6. Subjects that are skeletally immature (except for ProStop) (DynaNite Nitinol Staple Subjects ONLY) 7. Subjects who have a comminuted bone surface that would not allow for staple placement as required by the DynaNite Nitinol Staples directions for use 8. 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 |
| Country | Name | City | State |
|---|---|---|---|
| Germany | OrthoPedes | Duisburg | |
| South Africa | Dr Haroun Mahomed Orthopaedic Practice | Durban | |
| United States | TOA Research Foundation | Nashville | Tennessee |
| United States | UC Davis Medical Center | Sacramento | California |
| United States | Barrett Podiatry | San Antonio | Texas |
| Lead Sponsor | Collaborator |
|---|---|
| Arthrex, Inc. |
United States, Germany, South Africa,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 |