Status:
TERMINATED
Safety and Effectiveness of the QuickFix Small Staple
Lead Sponsor:
Arthrex GmbH
Conditions:
Hallux Valgus Interphalangeus
Eligibility:
All Genders
18+ years
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 i...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
May 25 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 29 2023
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04776356
Start Date
May 25 2021
End Date
June 29 2023
Last Update
August 28 2023
Active Locations (1)
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1
Überörtliche Gemeinschaftspraxis für Chirurgie, Unfallchirurgie, Anästhesie und Endoskopie
Meissen, Germany, 01662