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

Study Overview
=================
Brief Summary
-----------------
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.

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.

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

Conditions
-----------------
Osteochondral; Defect

Intervention / Treatment
-----------------
* Procedure: autologous osteo-periosteal cylinder graft transplantation
* Procedure: autologous osteochondral graft transplantation
* Device: autologous osteo-periosteal cylinder graft


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: autologous bone-periosteal graft<br>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<br>* Autologous osteo-periosteal cylinder graft transplantation is a novel treatment for Hepple V osteochondral lesions of the talus.<br>Device: autologous osteo-periosteal cylinder graft<br>* Autologous osteo-periosteal cylinder graft is taken from ilium.<br>|
| Active Comparator: autologous osteochondral graft<br>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<br>* Autologous osteochondral graft transplantation is the most common treatment for Hepple V osteochondral lesions of the talus.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| International Cartilage Repair Society(ICRS) score | International Cartilage Repair Society(ICRS) score. The higher score represent the better outcome. | 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. | 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. | 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. | 4 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
autologous osteo-periosteal cylinder graft, autologous osteochondral graft, randomized controlled trial, Hepple V osteochondral lesions of the talus