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

University of Oklahoma (OU)

Status: Withdrawn

Conditions: Metatarsophalangeal Joint Arthritis

Treatments: Device: Synthetic Cartilage Implant; Procedure: Osteochondral Autograft Transfer

Study type: Interventional

Funder types: Other

Identifiers

NCT03489876

SynCartImp_Amin

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Synthetic Cartilage Implant

Experimental group

Description:

Participants receive the synthetic cartilage implant. The synthetic cartilage implant that will be used is the Cartiva implant.

Treatment:

Device: Synthetic Cartilage Implant

Osteochondral Autograft Transfer

Active Comparator group

Description:

Participants receive the current standard osteochondral autograft transfer procedure.

Treatment:

Procedure: Osteochondral Autograft Transfer