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

N/AEnrolling By InvitationNCT03347877

Peking University Third Hospital70 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Osteochondral; Defect

Interventions

autologous osteo-periosteal cylinder graft transplantationPROCEDURE

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

autologous osteochondral graft transplantationPROCEDURE

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

autologous osteo-periosteal cylinder graftDEVICE

Autologous osteo-periosteal cylinder graft is taken from ilium.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (1)

Institute of Sports Medicine

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

American Orthopaedic Foot & Ankle Society(AOFAS) ankle-hindfoot score

American Orthopaedic Foot \& Ankle Society(AOFAS) ankle-hindfoot score. The higher score represent the better outcome.

Time frame: 4 years

Secondary Outcomes

International Cartilage Repair Society(ICRS) score

International Cartilage Repair Society(ICRS) score. The higher score represent the better outcome.

Time frame: 4 years

Magnetic Resonance Observation of cartilage repair tissue(MOCART) score

Magnetic Resonance Observation of cartilage repair tissue(MOCART) score. The higher score represent the better outcome.

Time frame: 4 years

Tegner activity level score

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.

Time frame: 4 years

Visual analogue scale

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.

Time frame: 4 years

Data from ClinicalTrials.gov

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