Synthetic Cartilage Implant vs Osteochondral Autograft Transfer for Advanced 1st Metatarsal Phalangeal Joint Arthritis

Study Overview
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Brief Summary
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This is a prospective, randomized, controlled clinical trial comparing synthetic cartilage implantation versus osteochondral autograft transfer for treatment of first metatarsophalangeal (MTP) arthritis. This data will allow for accurate comparisons between the two groups in regards to functional outcome, clinical outcome, pain relief, and complications.

Detailed Description
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First MTP joint arthritis or hallux rigidus is the most common arthritic condition of the foot. Historically, there have been several options to treat this condition surgically, but the current standard for advanced hallux rigidus is first MTP anthrodesis. Newer joint preserving procedures offer patients effective relief of pain and improving functional outcomes as well as maintaining, and potentially improving, range of motion for the first MTP joint. Osteochondral autograft transfer has been shown to be an effective treatment for hallux rigidus, and involves harvesting a small cylindrical osteochondral graft from a site remote of the first MTP joint and transferring the graft to the head of the first metatarsal. A new synthetic cartilage implant, Cartiva, has been shown to have equivalent functional outcomes, pain scores, and complications to anthrodesis, but the first MTP range of motion in the Cartiva group was maintained or even improved in some patients. This is a prospective, randomized, controlled clinical trial comparing synthetic cartilage implantation versus osteochondral autograft transfer for treatment of first metatarsophalangeal (MTP) arthritis. The hypothesis is that clinical range of motion, pain scores, subjective clinical outcomes, and complications will not be clinically inferior with the synthetic cartilage implant group compared to the osteochondral autograft transfer group.

Official Title
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Comparison of Synthetic Cartilage Implant Versus Osteochondral Autologous Transfer for Advanced Hallux Rigidus, A Prospective Randomized Controlled Clinical Trial

Conditions
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Metatarsophalangeal Joint Arthritis

Intervention / Treatment
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* Device: Synthetic Cartilage Implant
* Procedure: Osteochondral Autograft Transfer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Between the ages of 18 and 80 years old Grade 2 or 3 hallux rigidus based on Coughlin and Shurnas classification Presence of good bone stock as determined on pre-operative x-rays not requiring bone grafting Capable of consenting for self Exclusion Criteria: Patients <18 years of age Grade 1 or 4 hallux rigidus based on Coughlin and Shurnas classification Active bacterial infection of the foot Previous bilateral total knee arthroplasty Previous fracture or significant trauma to the ipsilateral knee Inflammatory anthropathy Gout Inadequate bone stock Previous anthrodesis or arthroplasty performed on the ipsilateral first MTP

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Upon eligibility verification and informed consent, computer-based randomization will allot patients into one of the two treatment groups, either synthetic cartilage implant or osteochondral autograft transfer.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Synthetic Cartilage Implant<br>Participants receive the synthetic cartilage implant. The synthetic cartilage implant that will be used is the Cartiva implant. | Device: Synthetic Cartilage Implant<br>* The Synthetic Cartilage Implant will be implanted in to the first metatarsal head according to the manufacturer's recommendations.<br>* Other names: Cartiva;|
| Active Comparator: Osteochondral Autograft Transfer<br>Participants receive the current standard osteochondral autograft transfer procedure. | Procedure: Osteochondral Autograft Transfer<br>* The osteochondral autograft transfer will be harvested from the ipsilateral lateral femoral condyle (or contralateral if a previous ipsilateral total knee anthroplasty or trauma) and the graft will be transferred to the first metatarsal head.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Range of Motion | Pre-operative and post-operative clinical range of motion of the first MTP joint | 2 years | 
| Patient's Pain Level | Pre-operative and post-operative visual analog pain scale | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient's Quality of Life | Foot and Ankle Ability Measure (FAAM) sports score uses patient-report to determine function | 2 years | 
| Clinically-Assessed Foot and Ankle Function | American Orthopedic Foot and Ankle Score (AOFAS) Hallux Metatarsophalangeal-Interphalangeal Scale | 2 years | 
| Health Status | 12-item short form health survey, use of concomitant medications, and changes in health status | 2 years | 
| Surgical Complications | Fractures, nerve injuries, blood loss, infection, etc. | 2 years | 
| Implant Failure | Failure of the Cartiva Synthetic Cartilage Implant | 2 years | 
| Secondary Surgical Intervention | Additional subsequent procedures, including removal, reoperation, revision, or supplemental fixation | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metatarsophalangeal Joint, Arthritis, Synthetic Cartilage Implant, Cartiva, Osteochondral Autograft Transfer