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Lack of patient enrollment.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Synthetic Cartilage Implant | Experimental | Participants receive the synthetic cartilage implant. The synthetic cartilage implant that will be used is the Cartiva implant. |
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| Osteochondral Autograft Transfer | Active Comparator | Participants receive the current standard osteochondral autograft transfer procedure. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Synthetic Cartilage Implant | Device | The Synthetic Cartilage Implant will be implanted in to the first metatarsal head according to the manufacturer's recommendations. |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amgad Amin, MD | Department of Orthopedic Surgery and Rehabilitation | Principal Investigator |
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| ID | Term |
|---|---|
| D001168 | Arthritis |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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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.
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The computer-based randomization sequence will be concealed from investigators using REDCap.
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| Osteochondral Autograft Transfer | Procedure | 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. |
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| 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 |