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Safety and Effectiveness of the QuickFix Small Staple

NCT04776356 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 12

Last updated 2023-08-28

No results posted yet for this study

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.

Conditions

  • Hallux Valgus Interphalangeus

Interventions

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.

Sponsors & Collaborators

  • Arthrex GmbH

    lead INDUSTRY

Principal Investigators

  • Tilo Schreiter, MD · Überörtliche Gemeinschaftspraxis für Chirurgie, Unfallchirurgie, Anästhesie und Endoskopie

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-25
Primary Completion
2023-06-29
Completion
2023-06-29

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04776356 on ClinicalTrials.gov