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

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 Overview

• Status: Terminated
• Conditions: Hallux Valgus Interphalangeus
• Intervention / Treatment: Device: QuickFix Small Staple (Arthrex)

• Study Type: Observational
• Enrollment (Actual): 12

Contacts and Locations

Study Locations

• Germany
  • Meissen, Germany, 01662
    • Überörtliche Gemeinschaftspraxis für Chirurgie, Unfallchirurgie, Anästhesie und Endoskopie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

45 subjects, male and female, at least 18 years of age from the general population who will be treated with the Arthrex QuickFix Small Staple to correct hallux valgus interphalangeus.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
QuickFix Small Staple; The QuickFix Small Staple will be used for an Akin osteotomy to correct hallux valgus interphalangeus.	Device: QuickFix 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.

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

Collaborators and Investigators

• Sponsor: Arthrex GmbH
• Investigators: Principal Investigator: Tilo Schreiter, MD, Überörtliche Gemeinschaftspraxis für Chirurgie, Unfallchirurgie, Anästhesie und Endoskopie

Study record dates

Study Major Dates

• Study Start (Actual): May 25, 2021
• Primary Completion (Actual): June 29, 2023
• Study Completion (Actual): June 29, 2023

Study Registration Dates

• First Submitted: February 23, 2021
• First Submitted That Met QC Criteria: February 26, 2021
• First Posted (Actual): March 1, 2021

Study Record Updates

• Last Update Posted (Actual): August 28, 2023
• Last Update Submitted That Met QC Criteria: August 24, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Staple
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Foot Deformities; Hallux Valgus
• Other Study ID Numbers: AIRR-0012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No