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Safety and Effectiveness of the QuickFix Small Staple

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04776356
Recruitment Status : Enrolling by invitation
First Posted : March 1, 2021
Last Update Posted : July 26, 2021
Sponsor:
Information provided by (Responsible Party):
Arthrex GmbH

Study Description
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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.

Condition or disease Intervention/treatment
Hallux Valgus Interphalangeus Device: QuickFix Small Staple (Arthrex)

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 45 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Prospective Study to Evaluate the Continued Safety and Effectiveness of the QuickFix Small Staple to Correct Hallux Valgus Interphalangeus
Actual Study Start Date : May 25, 2021
Estimated Primary Completion Date : May 2025
Estimated Study Completion Date : May 2025

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Bunion

Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Change of Visual Analogue Scale (VAS) [ Time Frame: preoperatively, 2 weeks, 6 week, 3 months, 6 months and 12 months postoperative ]
    Measuring pain in the affected foot. Range 0-10 (0=best, 10=worst).

  2. Change of Foot Function Index (FFI) [ Time Frame: preoperatively, 3 months, 6 months and 12 months postoperative ]
    Measuring foot functionality. Range 0-100 (0=best, 100=worst)

  3. Change of Foot and Ankle Ability Measure (FAAM Sport) [ Time Frame: preoperatively, 3 months, 6 months and 12 months postoperative ]
    Measuring foot functionality. Range 0-100 (0=worst, 100=best)

  4. Change of Veterans RAND 12 Iteam Health Survey (VR-12) [ Time Frame: preoperatively, 6 months and 12 months postoperative ]
    Measuring quality of life. Range 0-100 (0=worst, 100=best)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04776356


Locations
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Germany
Überörtliche Gemeinschaftspraxis für Chirurgie, Unfallchirurgie, Anästhesie und Endoskopie
Meissen, Germany, 01662
Sponsors and Collaborators
Arthrex GmbH
Investigators
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Principal Investigator: Tilo Schreiter, MD Überörtliche Gemeinschaftspraxis für Chirurgie, Unfallchirurgie, Anästhesie und Endoskopie
More Information
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Responsible Party: Arthrex GmbH
ClinicalTrials.gov Identifier: NCT04776356    
Other Study ID Numbers: AIRR-0012
First Posted: March 1, 2021    Key Record Dates
Last Update Posted: July 26, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Arthrex GmbH:
Staple
Additional relevant MeSH terms:
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Hallux Valgus
Foot Deformities
Musculoskeletal Diseases