Autologous Osteo-periosteal Cylinder Graft Transplantation for Hepple V Osteochondral Lesions of the Talus

August 20, 2025 updated by: Guo Qinwei, Peking University Third Hospital

Clinical Study of Autologous Osteo-periosteal Cylinder Graft Transplantation for Hepple V Osteochondral Lesions of the Talus

The trial evaluates the clinical efficacy and safety of autologous osteo-periosteal cylinder graft transplantation for Hepple V osteochondral lesions of the talus. Half of participants will receive autologous osteo-periosteal cylinder graft transplantation, while the other will receive osteochondral graft transplantation as a control group.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

Autologous osteo-periosteal cylinder graft surface is a periosteal structure, with the ability of repairment to cartilage, periosteum is closely connected to the cortical bone, then the deep loose cancellous bone.The objective of the study is to evaluate the clinical efficacy of autologous osteo-periosteal cylinder graft transplantation for Hepple V osteochondral lesions of the talus by randomized controlled trial. 70 patients with clinically diagnosed Hepple V talus osteochondral lesions according to 1: 1 were divided into experimental group and control group. The experimental group will be treated with autologous osteo-periosteal cylinder graft transplantation under arthroscopy. The control group will be treated with autologous osteochondral graft under arthroscopy. The patients will be treated by the same surgeon in this study group. Postoperative MRI MOCART evaluation, clinical AOFAS score, VAS score, Tegner score, and the secondary arthroscopy ICRS score will be selected as the measures of outcome. The incidence of adverse events will be recorded.

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100000
        • Institute of Sports Medicine

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

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 18-50 years old, male or female
  • Chronic pain in the ankle, confirmed by ankle joint MRI as Hepple V osteo-chondral lesions of the talus
  • Using rest/external use/oral non-steroidal anti-inflammatory drugs and other conservative treatment for more than 3 months ineffective
  • Patients voluntarily participated in clinical trials, signed informed consent, with clinical follow-up

Exclusion Criteria:

  • In the last 6 months patients participated in other drug or medical device clinical trials
  • Line of force in ankle is not correct (varus or valgus> 5 degrees)
  • Grade III ankle collateral ligament injury
  • Chronic specific synovitis (rheumatoid, pigmented villonodular synovitis, etc.)
  • Joint fibrosis, ankylosis, activity was significantly limited
  • Moderate and severe osteoarthritis
  • There are MRI contraindications
  • Hemophilia patients
  • The general condition of patients can not tolerate surgery
  • Pregnant or planned pregnant women and lactating women
  • Abnormal mental capacity without autonomy
  • Other conditions in which the doctor can not decide to participate in the trial

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

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: autologous bone-periosteal graft
The patients in experimental group will undergo the surgery of arthroscopic repair Hepple V osteochondral lesions of the talus with autologous osteo-periosteal cylinder graft transplantation.
Procedure: autologous osteo-periosteal cylinder graft transplantation
Autologous osteo-periosteal cylinder graft transplantation is a novel treatment for Hepple V osteochondral lesions of the talus.
Device: autologous osteo-periosteal cylinder graft
Autologous osteo-periosteal cylinder graft is taken from ilium.
Active Comparator: autologous osteochondral graft
The patients in control group will undergo the surgery of arthroscopic repair Hepple V osteochondral lesions of the talus with autologous osteochondral graft transplantation.
Procedure: autologous osteochondral graft transplantation
Autologous osteochondral graft transplantation is the most common treatment for Hepple V osteochondral lesions of the talus.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
American Orthopaedic Foot & Ankle Society(AOFAS) ankle-hindfoot score
Time Frame: 4 years
American Orthopaedic Foot & Ankle Society(AOFAS) ankle-hindfoot score. The higher score represent the better outcome.
4 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
International Cartilage Repair Society(ICRS) score
Time Frame: 4 years
International Cartilage Repair Society(ICRS) score. The higher score represent the better outcome.
4 years
Magnetic Resonance Observation of cartilage repair tissue(MOCART) score
Time Frame: 4 years
Magnetic Resonance Observation of cartilage repair tissue(MOCART) score. The higher score represent the better outcome.
4 years
Tegner activity level score
Time Frame: 4 years
The highest level of activity that you participated in before your injury and the highest level you are able to participate in currently. The higher values represent a better outcome.
4 years
Visual analogue scale
Time Frame: 4 years
The visual analogue scale or visual analog scale (VAS) is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points. From 0 to 10, no pain 0, worst pain imaginable 10. The higher values represent a worse outcome.
4 years

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, Peking University Third Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

January 1, 2018

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

November 15, 2017

First Submitted That Met QC Criteria

November 16, 2017

First Posted (Actual)

November 20, 2017

Study Record Updates

Last Update Posted (Estimated)

August 27, 2025

Last Update Submitted That Met QC Criteria

August 20, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PKU-GUO-01

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

No

product manufactured in and exported from the U.S.

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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