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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Osteochondral; Defect

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

autologous osteo-periosteal cylinder graft transplantation

Intervention Type PROCEDURE

Autologous osteo-periosteal cylinder graft transplantation is a novel treatment for Hepple V osteochondral lesions of the talus.

autologous osteo-periosteal cylinder graft

Intervention Type DEVICE

Autologous osteo-periosteal cylinder graft is taken from ilium.

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.

Group Type ACTIVE_COMPARATOR

autologous osteochondral graft transplantation

Intervention Type PROCEDURE

Autologous osteochondral graft transplantation is the most common treatment for Hepple V osteochondral lesions of the talus.

Interventions

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autologous osteo-periosteal cylinder graft transplantation

Autologous osteo-periosteal cylinder graft transplantation is a novel treatment for Hepple V osteochondral lesions of the talus.

Intervention Type PROCEDURE

autologous osteochondral graft transplantation

Autologous osteochondral graft transplantation is the most common treatment for Hepple V osteochondral lesions of the talus.

Intervention Type PROCEDURE

autologous osteo-periosteal cylinder graft

Autologous osteo-periosteal cylinder graft is taken from ilium.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No