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

NCT03489876 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2020-03-05

No results posted yet for this study

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.

Conditions

  • Metatarsophalangeal Joint Arthritis

Interventions

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.

Sponsors & Collaborators

  • University of Oklahoma

    lead OTHER

Principal Investigators

  • Amgad Amin, MD · Department of Orthopedic Surgery and Rehabilitation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-01
Primary Completion
2023-12-31
Completion
2025-12-31
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03489876 on ClinicalTrials.gov