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

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.

Study Overview

• Status: Withdrawn
• Conditions: Metatarsophalangeal Joint Arthritis
• Intervention / Treatment: Device: Synthetic Cartilage Implant; Procedure: Osteochondral Autograft Transfer

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 Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Synthetic Cartilage Implant; Participants receive the synthetic cartilage implant. The synthetic cartilage implant that will be used is the Cartiva implant.	Device: Synthetic Cartilage Implant; The Synthetic Cartilage Implant will be implanted in to the first metatarsal head according to the manufacturer's recommendations.; Other Names: Cartiva
Active Comparator: Osteochondral Autograft Transfer; Participants receive the current standard osteochondral autograft transfer procedure.	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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Oklahoma
• Investigators: Principal Investigator: Amgad Amin, MD, Department of Orthopedic Surgery and Rehabilitation

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2019
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2025

Study Registration Dates

• First Submitted: March 19, 2018
• First Submitted That Met QC Criteria: March 29, 2018
• First Posted (Actual): April 6, 2018

Study Record Updates

• Last Update Posted (Actual): March 5, 2020
• Last Update Submitted That Met QC Criteria: March 3, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Arthritis; Metatarsophalangeal Joint; Synthetic Cartilage Implant; Cartiva; Osteochondral Autograft Transfer
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Arthritis
• Other Study ID Numbers: SynCartImp_Amin

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes