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

Metatarsophalangeal Joint Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03489876
• Other study ID #: SynCartImp_Amin
• Status: Withdrawn
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: December 2025

Study information

• Verified date: March 2020
• Source: University of Oklahoma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2025
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Metatarsophalangeal Joint Arthritis

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Oklahoma

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Range of Motion	Pre-operative and post-operative clinical range of motion of the first MTP joint	2 years
Primary	Patient's Pain Level	Pre-operative and post-operative visual analog pain scale	2 years
Secondary	Patient's Quality of Life	Foot and Ankle Ability Measure (FAAM) sports score uses patient-report to determine function	2 years
Secondary	Clinically-Assessed Foot and Ankle Function	American Orthopedic Foot and Ankle Score (AOFAS) Hallux Metatarsophalangeal-Interphalangeal Scale	2 years
Secondary	Health Status	12-item short form health survey, use of concomitant medications, and changes in health status	2 years
Secondary	Surgical Complications	Fractures, nerve injuries, blood loss, infection, etc.	2 years
Secondary	Implant Failure	Failure of the Cartiva Synthetic Cartilage Implant	2 years
Secondary	Secondary Surgical Intervention	Additional subsequent procedures, including removal, reoperation, revision, or supplemental fixation	2 years