NCT03489876

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

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Oklahoma · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metatarsophalangeal Joint Arthritis

Interventions

Type	Name	Description
DEVICE	Synthetic Cartilage Implant	The Synthetic Cartilage Implant will be implanted in to the first metatarsal head according to the manufacturer's recommendations.
PROCEDURE	Osteochondral 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.

Timeline

• Start date: 2019-01-01
• Primary completion: 2023-12-01
• Completion: 2025-12-01
• First posted: 2018-04-06
• Last updated: 2020-03-05

Regulatory

• FDA-regulated device study