Safety and Effectiveness of the QuickFix Small Staple

Arthrex

Status: Terminated

Conditions: Hallux Valgus Interphalangeus

Treatments: Device: QuickFix Small Staple (Arthrex)

Study type: Observational

Funder types: Industry

Identifiers

NCT04776356

AIRR-0012

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

12 participants in 1 patient group

QuickFix Small Staple

Description:

The QuickFix Small Staple will be used for an Akin osteotomy to correct hallux valgus interphalangeus.

Treatment:

Device: QuickFix Small Staple (Arthrex)