Hallux RigidusNCT05518721
Synthetic Cartilage Implant Versus Interposition Arthroplasty in Hallux Rigidus Treatment: A Randomized Clinical Trial
A study testing Hallux Rigidus Treatment in people with Hallux Rigidus, run by John Femino at 1 site in United States.
Trial summary
A minimum of 100 patients with grade III hallux rigidus will be randomized in two parallel groups for surgical care. The first group will be submitted to the insertion of a synthetic cartilage implant at the metatarsophalangeal (MTP) joint. The second group will receive a dermal interposition arthroplasty at the MTP. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hallux Rigidus
- What is being tested?
- Hallux Rigidus Treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jul 2022to 14 Dec 2023
- Phase
- Interventional
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals must be older than 18 and younger than 75 years of age, both genders.
- Participants must be experiencing symptoms related to their baseline condition for at least six months before the surgery.
- Clinical and radiographical clinical diagnosis of hallux rigidus.
- Hallux Rigidus grade III or grade IV.
- Surgical indication after failure of nonoperative treatment (at least six months).
Who cannot join
- Previous hallux metatarsophalangeal fusion.
- Less than 20 degrees of complete range of motion on the hallux metatarsophalangeal joint.
- Patient desire or medical indication for a hallux metatarsophalangeal joint arthrodesis.
- Patient desire or medical indication for other surgical modalities.
- History or documented evidence of autoimmune or peripheral vascular diseases.
- History or documented evidence of peripheral neuropathy (nervous compression syndrome, tarsal tunnel syndrome) or systemic inflammatory disease a (rheumatoid arthritis, seronegative, connective, etc.).
Show all 15Show fewer
- Any condition that represents a contraindication of the proposed therapies.
- Any physical or social limitation that makes the protocol continuation unviable.
- Impossibility or incapacity to sign the informed Consent Form.
- Presence of infectious process (superficial on the skin and cellular tissue, or deep in the bone) in the region to be treated.
- Pregnancy.
- Clinical and imaging diagnosis of untreated osteoporosis.
- Serum vitamin D levels below 20ng/ml.
- Non-palpable anterior or posterior tibial pulse; or abnormal capillary filling.
- Tumor lesions (primary or secondary tumors).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Iowa Hospitals & Clinics
Iowa City, Iowa, 52242
About this study
A minimum of 100 patients with grade III hallux rigidus will be randomized in two parallel groups for surgical care. The first group will be submitted to the insertion of a synthetic cartilage implant at the metatarsophalangeal (MTP) joint. The second group will receive a dermal interposition arthroplasty at the MTP. Both sides will undergo the same post-operative protocol. Pain, complications, and functional results will be evaluated in a minimal of two years of follow-up.
Read the detailed description
A minimum of 100 patients with grade III hallux rigidus will be randomized in two parallel groups for surgical care. The first group will be submitted to the insertion of a synthetic cartilage implant at the metatarsophalangeal (MTP) joint. The second group will receive a dermal interposition arthroplasty at the MTP. Both sides will undergo the same post-operative protocol. Pain, complications, and functional results will be evaluated in a minimal of two years of follow-up.
The synthetic implant begins by performing and dorsal midline approach, from the proximal phalanx diaphysis to the first metatarsal neck. Dissection is carried avoiding injury to the dorsal cutaneous nerves and the extensor hallucis longus tendon. The capsule is open longitudinally, osteophytes removed, and a guidewire inserted through the center of the first metatarsal head. The position of the metallic wire is checked and the tunnel for the implant is drilled. The synthetic cartilage implant (Cartiva™, Stryker Medical®) is introduced through the tunnel, leaving it proud with the head surface by 2mm. The capsule is closed, followed by the other planes and the skin. The patient is banded and placed in a postoperative hard sole shoe for six weeks. Range of motion is encouraged from the third week and the shoe is discontinued after the sixth week. Return to sports activities and normal shoewear occurs by twelve weeks.
The interposition arthroplasty initiates with the same dorsal midline approach, from the proximal phalanx diaphysis to the first metatarsal neck. Dissection is carried avoiding injury to the dorsal cutaneous nerves and the extensor hallucis longus tendon. The capsule is open longitudinally and osteophytes are removed. A guidewire inserted through the center of the first metatarsal head and the center of the proximal phalanx for proper surface preparation. Convex-concaves anatomical drills are used, removing remaining cartilage and opening space for the graft. A decellularized dermal allograft (Arthroflex™, Arthrex®) is placed at the joint and sutured to the head, maintaining the epidermal surface in contact with the phalanx. The graft is trimmed, the capsule is closed, which is followed by the other planes and the skin. The patient is banded and placed in a postoperative hard sole shoe for six weeks. Range of motion is encouraged from the third week and the shoe is discontinued after the sixth week. Return to sports activities and normal shoewear occurs by twelve weeks.
The WBCT is the standard of care for the preoperative and postoperative assessment of patients with hallux rigidus. Some of the complications will also be evaluated through WBCT. No extra WBCT will be performed other than what we normally do for patients.
Randomization will be performed previously at the beginning of the study and will be performed by an outside researcher. Allocation will happen during surgery scheduling.
- Conditions
- Hallux Rigidus
- Being tested
- Hallux Rigidus Treatment
- Medical subject headings
- Hallux Rigidus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hallux Rigidus TreatmentProcedure or surgery
Participants will receive either a synthetic cartilage implant or dermal interposition arthroplasty
| Study group | Role | What they receive |
|---|---|---|
| Synthetic Cartilage Implant | Active comparator | Not described Receives: Procedure: Hallux Rigidus Treatment |
| Dermal Interposition Arthroplasty | Active comparator | Not described Receives: Procedure: Hallux Rigidus Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Reported Outcomes
To compare patient reported outcomes (PROs) of patients undergoing HR treatment using a synthetic implant and utilizing interposition arthroplasty.
Measured: 96 weeks post-surgery
Secondary outcomes (2)
Survival
To compare survival rate (reoperation) between the two techniques.
Measured: 6 months post-surgery
Complications
To compare major and minor complications between the two groups
Measured: 6 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2022
- Study start5 Jul 2022 (estimated)
- Primary completion14 Dec 2023
- Study completion14 Dec 2023
Why it stopped: Original PI left institution and successor has no interest in continuing project.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hallux RigidusStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- John Femino
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, John Femino, University of Iowa
- Investigators
- John Femino, MD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05518721
- Sponsor's protocol ID
- 202010411
- Status last verified
- Dec 2023
- First submitted
- 25 Aug 2022
- Last updated
- 20 Dec 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 20 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Synthetic Cartilage Implant Versus Interposition Arthroplasty in Hallux Rigidus Treatment: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05518721
- Acronym / sponsor ID
- 202010411
- Conditions
- Hallux Rigidus
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Original PI left institution and successor has no interest in continuing project.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- John FeminoUniversity, hospital or other
- Study start
- 5 Jul 2022 (estimated)
- Primary completion
- 14 Dec 2023 (actual)
- Study completion
- 14 Dec 2023 (actual)
- First posted
- 29 Aug 2022 (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.
A minimum of 100 patients with grade III hallux rigidus will be randomized in two parallel groups for surgical care. The first group will be submitted to the insertion of a synthetic cartilage implant at the metatarsophalangeal (MTP) joint. The second group will receive a dermal interposition arthroplasty at the MTP. Both sides will undergo the same post-operative protocol. Pain, complications, and functional results will be evaluated in a minimal of two years of follow-up.
Detailed description
A minimum of 100 patients with grade III hallux rigidus will be randomized in two parallel groups for surgical care. The first group will be submitted to the insertion of a synthetic cartilage implant at the metatarsophalangeal (MTP) joint. The second group will receive a dermal interposition arthroplasty at the MTP. Both sides will undergo the same post-operative protocol. Pain, complications, and functional results will be evaluated in a minimal of two years of follow-up.
The synthetic implant begins by performing and dorsal midline approach, from the proximal phalanx diaphysis to the first metatarsal neck. Dissection is carried avoiding injury to the dorsal cutaneous nerves and the extensor hallucis longus tendon. The capsule is open longitudinally, osteophytes removed, and a guidewire inserted through the center of the first metatarsal head. The position of the metallic wire is checked and the tunnel for the implant is drilled. The synthetic cartilage implant (Cartiva™, Stryker Medical®) is introduced through the tunnel, leaving it proud with the head surface by 2mm. The capsule is closed, followed by the other planes and the skin. The patient is banded and placed in a postoperative hard sole shoe for six weeks. Range of motion is encouraged from the third week and the shoe is discontinued after the sixth week. Return to sports activities and normal shoewear occurs by twelve weeks.
The interposition arthroplasty initiates with the same dorsal midline approach, from the proximal phalanx diaphysis to the first metatarsal neck. Dissection is carried avoiding injury to the dorsal cutaneous nerves and the extensor hallucis longus tendon. The capsule is open longitudinally and osteophytes are removed. A guidewire inserted through the center of the first metatarsal head and the center of the proximal phalanx for proper surface preparation. Convex-concaves anatomical drills are used, removing remaining cartilage and opening space for the graft. A decellularized dermal allograft (Arthroflex™, Arthrex®) is placed at the joint and sutured to the head, maintaining the epidermal surface in contact with the phalanx. The graft is trimmed, the capsule is closed, which is followed by the other planes and the skin. The patient is banded and placed in a postoperative hard sole shoe for six weeks. Range of motion is encouraged from the third week and the shoe is discontinued after the sixth week. Return to sports activities and normal shoewear occurs by twelve weeks.
The WBCT is the standard of care for the preoperative and postoperative assessment of patients with hallux rigidus. Some of the complications will also be evaluated through WBCT. No extra WBCT will be performed other than what we normally do for patients.
Randomization will be performed previously at the beginning of the study and will be performed by an outside researcher. Allocation will happen during surgery scheduling.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Synthetic Cartilage Implant | Active comparator | Procedure: Hallux Rigidus Treatment |
| Dermal Interposition Arthroplasty | Active comparator | Procedure: Hallux Rigidus Treatment |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Individuals must be older than 18 and younger than 75 years of age, both genders.
- Participants must be experiencing symptoms related to their baseline condition for at least six months before the surgery.
- Clinical and radiographical clinical diagnosis of hallux rigidus.
- Hallux Rigidus grade III or grade IV.
- Surgical indication after failure of nonoperative treatment (at least six months).
Key exclusion criteria (15 listed)
- Previous hallux metatarsophalangeal fusion.
- Less than 20 degrees of complete range of motion on the hallux metatarsophalangeal joint.
- Patient desire or medical indication for a hallux metatarsophalangeal joint arthrodesis.
- Patient desire or medical indication for other surgical modalities.
- History or documented evidence of autoimmune or peripheral vascular diseases.
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 |
|---|---|---|
| Hallux Rigidus TreatmentParticipants will receive either a synthetic cartilage implant or dermal interposition arthroplasty | Procedure or surgery | Dermal Interposition Arthroplasty, Synthetic Cartilage Implant |
Primary outcome
Patient Reported Outcomes
Time frame: 96 weeks post-surgery
To compare patient reported outcomes (PROs) of patients undergoing HR treatment using a synthetic implant and utilizing interposition arthroplasty.
2 secondary outcomes
Survival
Time frame: 6 months post-surgery
Complications
Time frame: 6 months post-surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2023.
- Individual participant dataSharing planned: No
Related trials for Hallux Rigidus
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Return to Cross Country Skiing and Other Physical Activities After Arthrodesis of the First Metatarsophalangeal Joint
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Performance and Safety Evaluation of Inion CompressOn Screw in Foot and Ankle Surgeries. PMCF Investigation
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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.
John Femino, MD principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hallux Rigidus Treatment in people with Hallux Rigidus, run by John Femino at 1 site in United States.
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 5 inclusion and 15 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: withdrawn, as of the sponsor's last update on 20 Dec 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 United States. 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 withdrawn before enrolling participants, so there are no results.
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?
Patient Reported Outcomes (time frame: 96 weeks post-surgery). 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 20 Dec 2023.