Prospective Study to Evaluate the Continued Safety and Effectiveness of the QuickFix Small Staple to Correct Hallux Valgus Interphalangeus
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Change of Foot and Ankle Ability Measure (FAAM Sport)
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Change of Foot and Ankle Ability Measure (FAAM Sport)
Time Frame: preoperatively, 3 months, 6 months and 12 months postoperative
Measuring foot functionality. Range 0-100 (0=worst, 100=best)
Change of Foot Function Index (FFI)
Time Frame: preoperatively, 3 months, 6 months and 12 months postoperative
Measuring foot functionality. Range 0-100 (0=best, 100=worst)
Change of Veterans RAND 12 Iteam Health Survey (VR-12)
Time Frame: preoperatively, 6 months and 12 months postoperative
Measuring quality of life. Range 0-100 (0=worst, 100=best)
Change of Visual Analogue Scale (VAS)
Time Frame: preoperatively, 2 weeks, 6 week, 3 months, 6 months and 12 months postoperative
Measuring pain in the affected foot. Range 0-10 (0=best, 10=worst).
Secondary Outcomes
No secondary outcomes reported