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

Not Applicable

Withdrawn

• Conditions: Metatarsophalangeal Joint Arthritis
• Interventions: Procedure: Osteochondral Autograft Transfer; Device: Synthetic Cartilage Implant

• Registration Number: NCT03489876
• Lead Sponsor: University of Oklahoma

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.

Study Timeline

• Study First Submitted: 2018-03-19
• Study First Submitted QC: 2018-03-29
• Study First Posted: 2018-04-06
• Study Start: 2019-01-01
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-03
• Last Update Posted: 2020-03-05
• Primary Completion: 2023-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Osteochondral Autograft Transfer	Osteochondral Autograft Transfer	Participants receive the current standard osteochondral autograft transfer procedure.
Synthetic Cartilage Implant	Synthetic Cartilage Implant	Participants receive the synthetic cartilage implant. The synthetic cartilage implant that will be used is the Cartiva implant.

Primary Outcome Measures

Name	Time	Method
Range of Motion	2 years	Pre-operative and post-operative clinical range of motion of the first MTP joint
Patient's Pain Level	2 years	Pre-operative and post-operative visual analog pain scale

Secondary Outcome Measures

Name	Time	Method
Clinically-Assessed Foot and Ankle Function	2 years	American Orthopedic Foot and Ankle Score (AOFAS) Hallux Metatarsophalangeal-Interphalangeal Scale
Patient's Quality of Life	2 years	Foot and Ankle Ability Measure (FAAM) sports score uses patient-report to determine function
Secondary Surgical Intervention	2 years	Additional subsequent procedures, including removal, reoperation, revision, or supplemental fixation
Health Status	2 years	12-item short form health survey, use of concomitant medications, and changes in health status
Surgical Complications	2 years	Fractures, nerve injuries, blood loss, infection, etc.
Implant Failure	2 years	Failure of the Cartiva Synthetic Cartilage Implant