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

Peking University

Status: Invitation-only

Conditions: Osteochondral; Defect

Treatments: Procedure: autologous osteo-periosteal cylinder graft transplantation; Device: autologous osteo-periosteal cylinder graft; Procedure: autologous osteochondral graft transplantation

Study type: Interventional

Funder types: Other

Identifiers

NCT03347877

PKU-GUO-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

autologous bone-periosteal graft

Experimental group

Description:

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.

Treatment:

Device: autologous osteo-periosteal cylinder graft

Procedure: autologous osteo-periosteal cylinder graft transplantation

autologous osteochondral graft

Active Comparator group

Description:

The patients in control group will undergo the surgery of arthroscopic repair Hepple V osteochondral lesions of the talus with autologous osteochondral graft transplantation.

Treatment:

Procedure: autologous osteochondral graft transplantation