Hallux Valgus InterphalangeusNCT04776356
Safety and Effectiveness of the QuickFix Small Staple
An observational study of Hallux Valgus Interphalangeus, run by Arthrex GmbH at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hallux Valgus Interphalangeus
- What is being tested?
- QuickFix Small Staple (Arthrex)
- Type of treatment
- Medical device
- How many people
- 12 participants
- Where
- 1 siteGermany
- Study dates
- 25 May 2021to 29 Jun 2023
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Überörtliche Gemeinschaftspraxis für Chirurgie, Unfallchirurgie, Anästhesie und Endoskopie
Meissen, 01662
About this study
Official title: Prospective Study to Evaluate the Continued Safety and Effectiveness of the QuickFix Small Staple to Correct Hallux Valgus Interphalangeus
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
- Being tested
- QuickFix Small Staple (Arthrex)
- Keywords
- Staple
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| QuickFix Small Staple | The QuickFix Small Staple will be used for an Akin osteotomy to correct hallux valgus interphalangeus. Receives: Device: QuickFix Small Staple (Arthrex) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Visual Analogue Scale (VAS)
Measuring pain in the affected foot. Range 0-10 (0=best, 10=worst).
Measured: 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)
Measured: 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)
Measured: 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)
Measured: preoperatively, 6 months and 12 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2021
- Study start25 May 2021
- Primary completion29 Jun 2023
- Study completion29 Jun 2023
Why it stopped: it was difficult to obtain subjects' consent
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hallux Valgus InterphalangeusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Arthrex GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tilo Schreiter, MD, Principal investigator, Überörtliche Gemeinschaftspraxis für Chirurgie, Unfallchirurgie, Anästhesie und Endoskopie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04776356
- Sponsor's protocol ID
- AIRR-0012
- Status last verified
- Aug 2023
- First submitted
- 23 Feb 2021
- Last updated
- 28 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study to Evaluate the Continued Safety and Effectiveness of the QuickFix Small Staple to Correct Hallux Valgus Interphalangeus
- ClinicalTrials.gov ID
- NCT04776356
- Acronym / sponsor ID
- AIRR-0012
- Conditions
- Hallux Valgus Interphalangeus
- Keywords
- Staple
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: it was difficult to obtain subjects' consent
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Arthrex GmbHIndustry (pharma, biotech, devices)
- Study start
- 25 May 2021 (actual)
- Primary completion
- 29 Jun 2023 (actual)
- Study completion
- 29 Jun 2023 (actual)
- First posted
- 1 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| QuickFix Small Staple | – | Device: QuickFix Small Staple (Arthrex)The QuickFix Small Staple will be used for an Akin osteotomy to correct hallux valgus interphalangeus. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | QuickFix Small Staple |
Primary outcome
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).
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)
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)
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)
Results and safety
The study was stopped early (reason given: it was difficult to obtain subjects' consent). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2023.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tilo Schreiter, MD principal investigator
Überörtliche Gemeinschaftspraxis für Chirurgie, Unfallchirurgie, Anästhesie und Endoskopie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hallux Valgus Interphalangeus, run by Arthrex GmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: it was difficult to obtain subjects' consent). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Visual Analogue Scale (VAS) (time frame: preoperatively, 2 weeks, 6 week, 3 months, 6 months and 12 months postoperative). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2023.