Autologous Osteoperiosteal Transplantation for the Treatment of Severe Osteochondral Lesions of the Talus

August 4, 2024 updated by: Peking University Third Hospital

A Multicenter Prospective Cohort Study of Autologous Osteoperiosteal Transplantation for the Treatment of Severe Osteochondral Lesions of the Talus

The goal of this clinical trial is to establish a multicenter prospective cohort of patients with severe osteochondral lesion of the talus (OLT), evaluate the clinical efficacy of autologous osteoperiosteal transplantation and the incidence of postoperative donor-site morbidity. The main questions it aims to answer are:

Does autologous osteoperiosteal transplantation have good clinical outcomes in the treatment of severe OLT? Does autologous osteoperiosteal transplantation treat severe OLT with fewer postoperative complications?

Participants will:

Undergo autologous osteoperiosteal transplantation for OLT Receive clinical follow-up 3, 6, 12, and 24 months after surgery and answer scales of ankle function assessment Take CT and MRI preoperatively and 12 and 24 months after surgery

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Qixian Shen, MD
  • Phone Number: +86 13318038398
  • Email: bjmusqx@163.com

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Peking University Third Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Severe OLT patients undergoing autologous osteoperiosteal transplantation that meet the above criteria

Description

Inclusion Criteria:

  • Chronic ankle pain, diagnosed as Osteochondral Lesions of the Talus (OLT);
  • Hepple V OLT on the medial side of the talus or the diameter of the lesion ≥ 8 mm;
  • Conservative treatment of at least 3 months fails to relieve symptoms;
  • Willingness to voluntarily participate in the trial and to sign informed consent.

Exclusion Criteria:

  • Varus or valgus deformity of the ankle of more than 5 degrees;
  • Grade III injury of the lateral collateral ligament of ankle;
  • Chronic synovitis (rheumatoid arthritis, pigmented villous nodular synovitis, etc.);
  • Joint fibrosis, stiffness, and significantly restricted range of motion;
  • Evidence of moderate to severe knee osteoarthritis on plain radiographs;
  • Failure to complete the rehabilitation protocol as required;
  • Patient medically not fit for surgery, radiographs or MRI;
  • For women, pregnant, planning to be pregnant or lactating.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Foot and Ankle Outcome Score (FAOS)
Time Frame: Pre-surgery and 6 weeks and 3, 6, 12 and 24 months after surgery
The Foot and Ankle Outcome Score (FAOS) is an extensive tool designed to evaluate the patient's perception of their foot and ankle conditions, with 0 indicating the worst possible outcome, and 100 representing the best possible outcome. The scale of FAOS score will be answered by participants during clinic follow-up preoperatively, and 6 weeks 3, 6, 12 and 24 months after surgery.
Pre-surgery and 6 weeks and 3, 6, 12 and 24 months after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complications
Time Frame: Final follow-up (48 months after surgery)
Complications, including infection,hematoma, stiffness, recurrent ankle pain will be continuously followed during clinic follow-up and will be overall collected 24 months after surgery.
Final follow-up (48 months after surgery)
American Orthopedic Foot and Ankle Society Score (AOFAS)
Time Frame: Pre-surgery and 6 weeks and 3, 6, 12 and 24 months after surgery
The AOFAS is a standardized tool used to evaluate the outcomes of treatments for foot and ankle disorders, with 0 indicating severe disability or extreme problems, and 100 indicating no disability or problems.The scale of AOFAS score will be answered by participants during clinic follow-up preoperatively, and 6 weeks 3, 6, 12 and 24 months after surgery.
Pre-surgery and 6 weeks and 3, 6, 12 and 24 months after surgery
Visual Analogue Scale (VAS)
Time Frame: Pre-surgery and 6 weeks and 3, 6, 12 and 24 months after surgery
The Visual Analog Scale (VAS) is a simple and widely used method for assessing the intensity of pain and other subjective experiences, with 0 indicating no pain, and 100 indicating the worst possible pain. The scale of VAS score will be answered by participants during clinic follow-up preoperatively, and 6 weeks 3, 6, 12 and 24 months after surgery.
Pre-surgery and 6 weeks and 3, 6, 12 and 24 months after surgery
Ankle Activity Score (AAS)
Time Frame: Pre-surgery and 6 weeks and 3, 6, 12 and 24 months after surgery
The AAS is a scoring tool to assess sports activity for the ankle joint, with zero point indicating the lowest activity level, and ten points indicating the highest activity level. The scale of AAS score will be answered by participants during clinic follow-up preoperatively, and 6 weeks 3, 6, 12 and 24 months after surgery.
Pre-surgery and 6 weeks and 3, 6, 12 and 24 months after surgery
Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART)
Time Frame: 12 and 24 months after surgery
The Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) score is a grading system used to evaluate the quality of cartilage repair tissue through MRI (Magnetic Resonance Imaging), with 0 indicating poor cartilage repair quality, and 100 indicating excellent cartilage repair quality. MOCART score will be assessed on magnetic resonance imaging 12 and 24 months after surgery.
12 and 24 months after surgery
International Cartilage Repair Society (ICRS)
Time Frame: 12 months after surgery
The International Cartilage Repair Society (ICRS) score is a grading system used to assess the condition of articular cartilage, especially in the context of cartilage repair procedures, with 0 indicating poor cartilage repair quality, and 12 indicating excellent cartilage repair quality. ICRS score will be assessed 12 months
12 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University Third Hospital

Investigators

  • Principal Investigator: Qinwei Guo, MD, Department of Sports Medicine, Peking University Third Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2023

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

July 25, 2024

First Submitted That Met QC Criteria

July 25, 2024

First Posted (Actual)

July 30, 2024

Study Record Updates

Last Update Posted (Actual)

August 6, 2024

Last Update Submitted That Met QC Criteria

August 4, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • M2023418

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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