Safety and Effectiveness of the QuickFix Small Staple

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Prospective Study to Evaluate the Continued Safety and Effectiveness of the QuickFix Small Staple to Correct Hallux Valgus Interphalangeus

Conditions
-----------------
Hallux Valgus Interphalangeus

Intervention / Treatment
-----------------
* Device: QuickFix Small Staple (Arthrex)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject requires surgery using the Arthrex QuickFix Small Staple for Akin osteotomy. Subject is 18 years of age or older. Subject is not considered a vulnerable subject (i.e. child, pregnant, nursing, prisoner, or ward of the state). Subject signed informed consent 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| QuickFix Small Staple<br>The QuickFix Small Staple will be used for an Akin osteotomy to correct hallux valgus interphalangeus. | Device: QuickFix Small Staple (Arthrex)<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Staple