Safety and Effectiveness of the QuickFix Small Staple

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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04776356

Enrollment

Registered

2021-03-01

Start date

2021-05-25

Completion date

2023-06-29

Last updated

2023-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hallux Valgus Interphalangeus

Keywords

Staple

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.

Interventions

DEVICEQuickFix Small Staple (Arthrex)

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.

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Change of Visual Analogue Scale (VAS)	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).
Change of Foot Function Index (FFI)	preoperatively, 3 months, 6 months and 12 months postoperative	Measuring foot functionality. Range 0-100 (0=best, 100=worst)
Change of Foot and Ankle Ability Measure (FAAM Sport)	preoperatively, 3 months, 6 months and 12 months postoperative	Measuring foot functionality. Range 0-100 (0=worst, 100=best)
Change of Veterans RAND 12 Iteam Health Survey (VR-12)	preoperatively, 6 months and 12 months postoperative	Measuring quality of life. Range 0-100 (0=worst, 100=best)

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026