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it was difficult to obtain subjects' consent
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The prospective, post-market, single-center clinical study will include 45 subjects who are candidates for surgery using the Arthrex QuickFix Small Staple for Akin osteotomy to correct hallux valgus interphalangeus. The purpose of the study is to evaluate the continued safety and effectiveness of the device. Device-related adverse events as well as patient reported outcomes (VAS, FFI, FAAM, VR-12) will be collected up to 1 year postoperative.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QuickFix Small Staple | The QuickFix Small Staple will be used for an Akin osteotomy to correct hallux valgus interphalangeus. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QuickFix Small Staple (Arthrex) | Device | The Arthrex QuickFix Small Staple enables the surgeon to perform a wedge osteotomy of the first phalanx (Akin). The device is made of stainless steel and designed with barbed leg tips. The staple sizes are 8 and 10 mm wide with a 1 mm diameter. |
| Measure | Description | Time Frame |
|---|---|---|
| Change of Visual Analogue Scale (VAS) | Measuring pain in the affected foot. Range 0-10 (0=best, 10=worst). | preoperatively, 2 weeks, 6 week, 3 months, 6 months and 12 months postoperative |
| Change of Foot Function Index (FFI) | Measuring foot functionality. Range 0-100 (0=best, 100=worst) | preoperatively, 3 months, 6 months and 12 months postoperative |
| Change of Foot and Ankle Ability Measure (FAAM Sport) | Measuring foot functionality. Range 0-100 (0=worst, 100=best) | preoperatively, 3 months, 6 months and 12 months postoperative |
| Change of Veterans RAND 12 Iteam Health Survey (VR-12) | Measuring quality of life. Range 0-100 (0=worst, 100=best) | preoperatively, 6 months and 12 months postoperative |
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Inclusion Criteria:
Exclusion Criteria:
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45 subjects, male and female, at least 18 years of age from the general population who will be treated with the Arthrex QuickFix Small Staple to correct hallux valgus interphalangeus.
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| Name | Affiliation | Role |
|---|---|---|
| Tilo Schreiter, MD | Überörtliche Gemeinschaftspraxis für Chirurgie, Unfallchirurgie, Anästhesie und Endoskopie | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Überörtliche Gemeinschaftspraxis für Chirurgie, Unfallchirurgie, Anästhesie und Endoskopie | Meissen | 01662 | Germany |
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