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

Not Applicable

Interventions: Procedure: autologous osteo-periosteal cylinder graft transplantation
Procedure: autologous osteochondral graft transplantation
Device: autologous osteo-periosteal cylinder graft

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
autologous bone-periosteal graft	autologous osteo-periosteal cylinder graft transplantation	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.
autologous bone-periosteal graft	autologous osteo-periosteal cylinder 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.
autologous osteochondral graft	autologous osteochondral graft transplantation	The patients in control group will undergo the surgery of arthroscopic repair Hepple V osteochondral lesions of the talus with autologous osteochondral graft transplantation.

Primary Outcome Measures

Name	Time	Method
American Orthopaedic Foot & Ankle Society(AOFAS) ankle-hindfoot score	4 years	American Orthopaedic Foot \& Ankle Society(AOFAS) ankle-hindfoot score. The higher score represent the better outcome.

Secondary Outcome Measures

Name	Time	Method
Tegner activity level score	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.
International Cartilage Repair Society(ICRS) score	4 years	International Cartilage Repair Society(ICRS) score. The higher score represent the better outcome.
Magnetic Resonance Observation of cartilage repair tissue(MOCART) score	4 years	Magnetic Resonance Observation of cartilage repair tissue(MOCART) score. The higher score represent the better outcome.
Visual analogue scale	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.