Hyperpronated FootNCT04715139
Evaluate the Continued Safety and Performance of the Foot and Ankle Products
An observational study of Hyperpronated Foot and Reconstruction Surgeries of the Foot, run by Arthrex, Inc. at 7 sites in 3 countries.
Trial summary
The objective of the registry is to evaluate the continued safety and performance of Arthrex foot and ankle products, including the ProStop® implant for hyperpronated foot; Bio-Compression Screw for reconstruction surgeries of the foot; TRIM-IT Drill Pin® system and/or TRIM-IT Spin Pin™ system for fixation of… Read more about this study
- Who is it for?
- Ages 2 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hyperpronated Foot, Reconstruction Surgeries of the Foot, Fixation of Fractures and Fusion (Bunionectomy Osteotomies) of the Foot/Ankle
- What is being tested?
- Products listed in Group/Cohort Description
- Type of treatment
- Medical device
- How many people
- 700 participants
- Where
- 7 sitesin 3 countries
- Study dates
- 1 Dec 2020to 31 Dec 2027
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 2 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Approximately 700 subjects (50 subjects per product/indication pair) will be enrolled. The subject population will be male and female,18 years of age or older, with the exception of ProStop®, which includes subjects aged >2 to 17 years of age. Subjects will be recruited from the surgeon's patient population or referrals from other physicians.
Who may be able to join
- Subject requires surgery using Arthrex foot and ankle products included in the registry.
- Subject is 18 years of age or over (all products except ProStop®).
- Subject age >two to 17 years (ProStop® product only).
- Capable of completing self-administered questionnaires.
- Willing and able to return for all study-related follow-up visits.
- Subject or subject's representative signed informed consent and assent, when applicable, and is willing and able to comply with all study requirements.
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- (ArthroFLEX® subjects only):
- Degenerative or post-traumatic arthritis of the 1st MTP joint with grade 2, 3, or 4.
- Subjects who require surgical intervention or are medically indicated for an arthrodesis or arthroplasty of the 1st MTP.
- DualCompression Hindfoot Nail subjects only:
- The participant must have instability, arthritis, rigid deformity, or severe foot or ankle deformity necessitating tibiotalocalcaneal arthrodesis, commonly referred to as TTC arthrodesis.
- The participant should be undergoing treatment with the Arthrex DualCompression Hindfoot Nail, either as a primary procedure or as a revision surgery, per standard of care
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 (except for ProStop®).
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- Subject is considered from vulnerable population (i.e., child, prisoner, pregnant).
- Subjects who are contraindicated for these devices.
- Subject is currently receiving compensation or benefits due to a work-related injury or illness under any applicable occupational injury or disability program.
- Subject has a planned or scheduled additional surgery on the affected or contralateral lower extremity within the course of the study.
- (® Nitinol Staple Subjects only):
- Subjects who have a comminuted bone surface that would not allow for staple placement as required by the DynaNite® Nitinol Staples directions for use.
- Subjects who have pathologic bone conditions such as osteopenia that would impair the ability to securely fix the implant as required by the DynaNite® Nitinol Staples directions for use.
- (ArthroFLEX® subjects only):
- Additional ipsilateral lower limb pathology that requires active treatment.
- Bilateral degenerative or post-traumatic arthritis of the 1st MTP joints that would require simultaneous treatment of both MTP joints.
- Diagnosis of gout.
- Any significant bone loss, avascular necrosis, and/or large osteochondral cyst (>1cm) of the 1st MTP joint.
- Lesions greater than 10mm in size.
- Hallux varus to any degree, or hallux valgus >20 degrees.
- (DualCompression Hindfoot Nail subjects only):
- Requiring only a tibiotalar or subtalar arthrodesis
- Patient requires bulk allograft or metal spacer implant to fill large bony defect and aid in limb salvage
Trial locations and contacts
7 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
7 sites in 3 countries
United States5 sites, 3 recruiting
- Recruiting
Northwestern University
Chicago, Illinois, 60611
Stacy Ngwa, (312) 503-7955, SponsoredResearch@northwestern.edu
Muhammad Mutawakkil, MD
- Terminated
TOA Research Foundation
Nashville, Tennessee, 37209
- Recruiting
UC Davis Medical Center
Sacramento, California, 95817
Gaby Zumaran
Christopher Kreulen, MD
- Terminated
Barrett Podiatry
San Antonio, Texas, 78258
- Recruiting
Atlantic Orthopaedic Specialists
Virginia Beach, Virginia, 23462
Ashley Suttmiller Coordinator, 757-321-3360, suttmillera@atlanticortho.com
Blake Moore, MD
South Africa1 site
- Terminated
Dr Haroun Mahomed Orthopaedic Practice
Durban, 3629
About this study
Official title: A Multi-Center, Prospective Registry to Evaluate the Continued Safety and Performance of the Foot and Ankle Products
The objective of the registry is to evaluate the continued safety and performance of Arthrex foot and ankle products, including the ProStop® implant for hyperpronated foot; Bio-Compression Screw for reconstruction surgeries of the foot; TRIM-IT Drill Pin® system and/or TRIM-IT Spin Pin™ system for fixation of fractures and fusion (bunionectomy osteotomies) of the foot/ankle; Headless Compression Screws and Compression FT Screws for fixation of small bone fragments of the foot/ankle; DynaNite® nitinol staple for midfoot and hindfoot arthrodeses or osteotomies, first metatarsophalangeal arthrodesis, and mono or bi-cortical osteotomies in the forefoot; BioComposite SutureTak® anchor for medial ankle stabilization; Beveled FT Screws for hallux valgus repair; KreuLock™ screws for ankle fractures; ArthroFLEX® dermal allograft for hallux rigidus arthroplasty; and DualCompression Hindfoot Nail for tibiotalocalcaneal arthrodesis.
Read the detailed description
Device-related adverse events will be continuously assessed and summarized at three months, six months, one year, and two years postoperatively to evaluate safety. A physical exam of the target area will be conducted three months postoperatively to evaluate performance. Range of motion (ROM) will be assessed preoperatively, at three months, six months, and one year postoperatively for the ArthroFLEX® dermal allograft only. Patient-reported outcomes (PROs) will be evaluated for all products at three months, six months, and one year. Additionally, PROs will be assessed at two years postoperatively for ArthroFLEX® dermal allograft and DualCompression Hindfoot Nail only. PROs include the Foot and Ankle Ability Measures (FAAM), Visual Analogue Scale (VAS), Single Assessment Numeric Evaluation (SANE) score, and Veterans Rand 12-Item Health Survey (VR-12). DualCompression X-rays will be evaluated at six months and one year postoperatively for ArthroFLEX® dermal allograft and DualCompression Hindfoot Nail only, and CT scans will be assessed at three months postoperatively for DualCompression Hindfoot Nail only.
- Conditions
- Hyperpronated Foot, Reconstruction Surgeries of the Foot, Fixation of Fractures and Fusion (Bunionectomy Osteotomies) of the Foot/Ankle, Fixation of Small Bone Fragments of the Foot/Ankle, Lisfranc Arthrodesis, Mono or Bi-cortical Osteotomies in the Forefoot
- Being tested
- Products listed in Group/Cohort Description
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Products listed in Group/Cohort DescriptionDevice
Depending on approved indication per product
| Study group | Role | What they receive |
|---|---|---|
| All Products listed in Descriptions | * ProStop
* BioCompression Screw
* TRIM-IT Drill Pin/TRIM-IT Spin Pin
* Headless Compression Screw/Compression FT Screw
* DynaNite Nitinol Staple
* BioComposite SutureTak Anchor
* Beveled Headed FT Screw
* KreuLock Screws
* ArthroFLEX dermal allograft
* DualCompression Hindfoot Nail Receives: Device: Products listed in Group/Cohort Description |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess change in Visual Analogue Scale (VAS) survey
Patient reported pain scale 0-10 point scale (0 min, 10 max)
Measured: preoperatively, 3 months, 6 months and 12 months post operative
To assess changes in Veterans RAND Health (VR-12) survey
Patient reported changes in general health and mental survey. Average score is 50 (negative answers bring scores down, positive answers bring score up)
Measured: preoperatively, 3 months, 6 months and 12 months post operative
To assess changes in Foot and Ankle Ability Measures (FAAM) survey
Patient reported change to physical function for individuals with foot and ankle related impairments. A higher score represents a higher level of physical function
Measured: preoperatively, 3 months, 6 months and 12 months post operative
To assess change in Single Assessment Numeric Evaluation (SANE) survey
Patient reported change to affected body part on a scale from 0 to 100, with 100 representing their normal function.
Measured: preoperatively, 3 months, 6 months and 12 months post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2021
- Study start1 Dec 2020
- Primary completion1 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hyperpronated FootStudies 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
- 700 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Arthrex, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04715139
- Sponsor's protocol ID
- AIRR-0006
- Status last verified
- Jun 2025
- First submitted
- 15 Jan 2021
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Prospective Registry to Evaluate the Continued Safety and Performance of the Foot and Ankle Products
- ClinicalTrials.gov ID
- NCT04715139
- Acronym / sponsor ID
- AIRR-0006
- Conditions
- Hyperpronated Foot, Reconstruction Surgeries of the Foot, Fixation of Fractures and Fusion (Bunionectomy Osteotomies) of the Foot/Ankle, Fixation of Small Bone Fragments of the Foot/Ankle, Lisfranc Arthrodesis, Mono or Bi-cortical Osteotomies in the Forefoot
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Arthrex, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 20 Jan 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 objective of the registry is to evaluate the continued safety and performance of Arthrex foot and ankle products, including the ProStop® implant for hyperpronated foot; Bio-Compression Screw for reconstruction surgeries of the foot; TRIM-IT Drill Pin® system and/or TRIM-IT Spin Pin™ system for fixation of fractures and fusion (bunionectomy osteotomies) of the foot/ankle; Headless Compression Screws and Compression FT Screws for fixation of small bone fragments of the foot/ankle; DynaNite® nitinol staple for midfoot and hindfoot arthrodeses or osteotomies, first metatarsophalangeal arthrodesis, and mono or bi-cortical osteotomies in the forefoot; BioComposite SutureTak® anchor for medial ankle stabilization; Beveled FT Screws for hallux valgus repair; KreuLock™ screws for ankle fractures; ArthroFLEX® dermal allograft for hallux rigidus arthroplasty; and DualCompression Hindfoot Nail for tibiotalocalcaneal arthrodesis.
Detailed description
Device-related adverse events will be continuously assessed and summarized at three months, six months, one year, and two years postoperatively to evaluate safety. A physical exam of the target area will be conducted three months postoperatively to evaluate performance. Range of motion (ROM) will be assessed preoperatively, at three months, six months, and one year postoperatively for the ArthroFLEX® dermal allograft only. Patient-reported outcomes (PROs) will be evaluated for all products at three months, six months, and one year. Additionally, PROs will be assessed at two years postoperatively for ArthroFLEX® dermal allograft and DualCompression Hindfoot Nail only. PROs include the Foot and Ankle Ability Measures (FAAM), Visual Analogue Scale (VAS), Single Assessment Numeric Evaluation (SANE) score, and Veterans Rand 12-Item Health Survey (VR-12). DualCompression X-rays will be evaluated at six months and one year postoperatively for ArthroFLEX® dermal allograft and DualCompression Hindfoot Nail only, and CT scans will be assessed at three months postoperatively for DualCompression Hindfoot Nail only.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Products listed in Descriptions | – | Device: Products listed in Group/Cohort Description* ProStop * BioCompression Screw * TRIM-IT Drill Pin/TRIM-IT Spin Pin * Headless Compression Screw/Compression FT Screw * DynaNite Nitinol Staple * BioComposite SutureTak Anchor * Beveled Headed FT Screw * KreuLock Screws * ArthroFLEX dermal allograft * DualCompression Hindfoot Nail |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Approximately 700 subjects (50 subjects per product/indication pair) will be enrolled. The subject population will be male and female,18 years of age or older, with the exception of ProStop®, which includes subjects aged >2 to 17 years of age. Subjects will be recruited from the surgeon's patient population or referrals from other physicians.
Key inclusion criteria (12 listed)
- Subject requires surgery using Arthrex foot and ankle products included in the registry.
- Subject is 18 years of age or over (all products except ProStop®).
- Subject age >two to 17 years (ProStop® product only).
- Capable of completing self-administered questionnaires.
- Willing and able to return for all study-related follow-up visits.
Key exclusion criteria (23 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 |
|---|---|---|
| Products listed in Group/Cohort DescriptionDepending on approved indication per product | Device | All Products listed in Descriptions |
Primary outcome
To assess change in Visual Analogue Scale (VAS) survey
Time frame: preoperatively, 3 months, 6 months and 12 months post operative
Patient reported pain scale 0-10 point scale (0 min, 10 max)
To assess changes in Veterans RAND Health (VR-12) survey
Time frame: preoperatively, 3 months, 6 months and 12 months post operative
Patient reported changes in general health and mental survey. Average score is 50 (negative answers bring scores down, positive answers bring score up)
To assess changes in Foot and Ankle Ability Measures (FAAM) survey
Time frame: preoperatively, 3 months, 6 months and 12 months post operative
Patient reported change to physical function for individuals with foot and ankle related impairments. A higher score represents a higher level of physical function
To assess change in Single Assessment Numeric Evaluation (SANE) survey
Time frame: preoperatively, 3 months, 6 months and 12 months post operative
Patient reported change to affected body part on a scale from 0 to 100, with 100 representing their normal function.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2026.
- Individual participant dataSharing planned: Undecided
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.
7 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperpronated Foot and Reconstruction Surgeries of the Foot, run by Arthrex, Inc. at 7 sites in 3 countries.
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 12 inclusion and 23 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: looking for participants now, as of the sponsor's last update on 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Germany, South Africa. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Justin Moss, DHSc (770 584 4972, justin.moss@arthrex.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess change in Visual Analogue Scale (VAS) survey (time frame: preoperatively, 3 months, 6 months and 12 months post operative). 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 11 Feb 2026.