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

NCT03347877 | Enrolling By Invitation

• 1 other identifier: PKU-GUO-01
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteochondral; Defect

Keywords

autologous osteo-periosteal cylinder graft; autologous osteochondral graft; randomized controlled trial; Hepple V osteochondral lesions of the talus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• International Cartilage Repair Society(ICRS) score

  4 years

• Magnetic Resonance Observation of cartilage repair tissue(MOCART) score

  4 years

• Tegner activity level score

  4 years

• Visual analogue scale

  4 years

Study Arms (2)

autologous bone-periosteal graft

EXPERIMENTAL

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; Device: autologous osteo-periosteal cylinder graft

autologous osteochondral graft

ACTIVE COMPARATOR

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

Interventions

autologous osteo-periosteal cylinder graft transplantation PROCEDURE

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

autologous bone-periosteal graft

autologous osteochondral graft transplantation PROCEDURE

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

autologous osteochondral graft

autologous osteo-periosteal cylinder graft DEVICE

Autologous osteo-periosteal cylinder graft is taken from ilium.

autologous bone-periosteal graft

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Institute of Sports Medicine

Beijing, Beijing Municipality, 100000, China

Location

Related Publications (2)

• Yang S, Hu F, Shao Q, Zhang Z, Liu X, Jiang Y, Jiang D, Xie X, Jiao C, Hu Y, Shi W, Guo Q. Autologous Osteoperiosteal Transplantation Versus Autologous Osteochondral Transplantation for Large Cystic Osteochondral Lesions of the Medial Talus: 2-Year Results From a Prospective Randomized Controlled Trial. Am J Sports Med. 2025 Sep;53(11):2642-2651. doi: 10.1177/03635465251361505. Epub 2025 Aug 19.

  PMID: 40828751 DERIVED

• 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.

  PMID: 32041859 DERIVED

Study Officials

• Qinwei Guo

  Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Clinical Associate Professor and Chief Orthopedist of Orthopedic Sports Medicine

Study Record Dates

• First Submitted: November 15, 2017
• First Posted: November 20, 2017
• Study Start: January 1, 2018
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 27, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)