Safety and Effectiveness of the QuickFix Small Staple

Hallux Valgus Interphalangeus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04776356
• Other study ID #: AIRR-0012
• Status: Terminated
• Start date: May 25, 2021
• Est. completion date: June 29, 2023

Study information

• Verified date: August 2023
• Source: Arthrex GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: June 29, 2023
• Est. primary completion date: June 29, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hallux Valgus
• Hallux Valgus Interphalangeus

Intervention

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.

Locations

Country	Name	City	State
Germany	Überörtliche Gemeinschaftspraxis für Chirurgie, Unfallchirurgie, Anästhesie und Endoskopie	Meissen

Sponsors (1)

Lead Sponsor	Collaborator
Arthrex GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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