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

NCT ID: NCT03489876

Last Updated: 2020-03-05

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2025-12-31

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.

Conditions

Metatarsophalangeal Joint Arthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Synthetic Cartilage Implant

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

Group Type: EXPERIMENTAL

Synthetic Cartilage Implant

Intervention Type: DEVICE

The Synthetic Cartilage Implant will be implanted in to the first metatarsal head according to the manufacturer's recommendations.

Osteochondral Autograft Transfer

Participants receive the current standard osteochondral autograft transfer procedure.

Group Type: ACTIVE_COMPARATOR

Osteochondral Autograft Transfer

Intervention Type: 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.

Interventions

Synthetic Cartilage Implant

The Synthetic Cartilage Implant will be implanted in to the first metatarsal head according to the manufacturer's recommendations.

Intervention Type: DEVICE

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.

Intervention Type: PROCEDURE

Other Intervention Names

Cartiva

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Oklahoma

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amgad Amin, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Orthopedic Surgery and Rehabilitation

Other Identifiers

SynCartImp_Amin

Identifier Type: -

Identifier Source: org_study_id