Clinical trial NCT03347877: Autologous Osteo-periosteal Cylinder Graft Transplantation for Hepple V Osteochondral Lesions of the Talus
Official title: Clinical Study of Autologous Osteo-periosteal Cylinder Graft Transplantation for Hepple V Osteochondral Lesions of the Talus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteochondral; Defect
Keywords: autologous osteo-periosteal cylinder graft
autologous osteochondral graft
randomized controlled trial
Hepple V osteochondral lesions of the talus
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2017-11-20
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: American Orthopaedic Foot & Ankle Society(AOFAS) ankle-hindfoot score
timeFrame: 4 years
Secondary outcomes:
measure: International Cartilage Repair Society(ICRS) score
timeFrame: 4 years
measure: Magnetic Resonance Observation of cartilage repair tissue(MOCART) score
timeFrame: 4 years
measure: Tegner activity level score
timeFrame: 4 years
measure: Visual analogue scale
timeFrame: 4 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Institute of Sports Medicine
state: Beijing
Study officials:
affiliation: Peking University Third Hospital
name: Qinwei Guo
role: PRINCIPAL_INVESTIGATOR
References:
citation: Deng E, Shi W, Jiang Y, Guo Q. Comparison of autologous osteoperiosteal cylinder and osteochondral graft transplantation in the treatment of large cystic osteochondral lesions of the talus (OLTs): a protocol for a non-inferiority randomised controlled trial. BMJ Open. 2020 Feb 9;10(2):e033850. doi: 10.1136/bmjopen-2019-033850.