Safety and Effectiveness of the QuickFix Small Staple

NCT04776356 | Terminated

• 1 other identifier: AIRR-0012
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Hallux Valgus Interphalangeus

Keywords

Staple

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (1)

QuickFix Small Staple

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

Device: QuickFix Small Staple (Arthrex)

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.

QuickFix Small Staple

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Subject requires surgery using the Arthrex QuickFix Small Staple for Akin osteotomy.
• Subject is 18 years of age or older.
• Subject is not considered a vulnerable subject (i.e. child, pregnant, nursing, prisoner, or ward of the state).
• Subject signed informed consent and is willing and able to comply with all study requirements.

You may not qualify if:

• Insufficient quantity or quality of bone.
• Blood supply limitations and previous infections which may retard healing.
• Foreign-body sensitivity.
• Any active infection or blood supply limitations.
• Conditions that tend to limit the patient's ability or willingness to restrict activities or follow directions during the healing period.
• Subjects that are skeletally immature.

Sponsors & Collaborators

• Arthrex GmbH: lead

Study Sites (1)

Überörtliche Gemeinschaftspraxis für Chirurgie, Unfallchirurgie, Anästhesie und Endoskopie

Meissen, 01662, Germany

Location

Study Officials

• Tilo Schreiter, MD

  Überörtliche Gemeinschaftspraxis für Chirurgie, Unfallchirurgie, Anästhesie und Endoskopie

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2021
• First Posted: March 1, 2021
• Study Start: May 25, 2021
• Primary Completion: June 29, 2023
• Study Completion: June 29, 2023
• Last Updated: August 28, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)