Metatarsophalangeal Joint Arthritis Clinical Trial
Official title:
Comparison of Synthetic Cartilage Implant Versus Osteochondral Autologous Transfer for Advanced Hallux Rigidus, A Prospective Randomized Controlled Clinical Trial
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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