Safety and Effectiveness of the QuickFix Small Staple

Arthrex GmbH12 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Hallux Valgus Interphalangeus

Interventions

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Subject requires surgery using the Arthrex QuickFix Small Staple for Akin osteotomy. 2. Subject is 18 years of age or older. 3. Subject is not considered a vulnerable subject (i.e. child, pregnant, nursing, prisoner, or ward of the state). 4. Subject signed informed consent 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.

Locations (1)

Überörtliche Gemeinschaftspraxis für Chirurgie, Unfallchirurgie, Anästhesie und Endoskopie

Meissen, Germany

Outcomes

Primary Outcomes

Change of Visual Analogue Scale (VAS)

Measuring pain in the affected foot. Range 0-10 (0=best, 10=worst).

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: preoperatively, 6 months and 12 months postoperative

Data from ClinicalTrials.gov

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