Metatarsophalangeal Joint Arthritis
Conditions
Keywords
Metatarsophalangeal Joint, Arthritis, Synthetic Cartilage Implant, Cartiva, Osteochondral Autograft Transfer
Brief summary
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
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.
Interventions
DEVICESynthetic Cartilage Implant
The Synthetic Cartilage Implant will be implanted in to the first metatarsal head according to the manufacturer's recommendations.
PROCEDUREOsteochondral Autograft Transfer
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.
Sponsors
University of Oklahoma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
The computer-based randomization sequence will be concealed from investigators using REDCap.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Range of Motion | 2 years | Pre-operative and post-operative clinical range of motion of the first MTP joint |
| Patient's Pain Level | 2 years | Pre-operative and post-operative visual analog pain scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Health Status | 2 years | 12-item short form health survey, use of concomitant medications, and changes in health status |
| Surgical Complications | 2 years | Fractures, nerve injuries, blood loss, infection, etc. |
| Patient's Quality of Life | 2 years | Foot and Ankle Ability Measure (FAAM) sports score uses patient-report to determine function |
| Secondary Surgical Intervention | 2 years | Additional subsequent procedures, including removal, reoperation, revision, or supplemental fixation |
| Implant Failure | 2 years | Failure of the Cartiva Synthetic Cartilage Implant |
| Clinically-Assessed Foot and Ankle Function | 2 years | American Orthopedic Foot and Ankle Score (AOFAS) Hallux Metatarsophalangeal-Interphalangeal Scale |
Outcome results
None listed