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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Qinwei Guo | Peking University Third Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Sports Medicine | Beijing | Beijing Municipality | 100000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40828751 | Derived | 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. | |
| 32041859 |
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| autologous osteochondral graft transplantation | Procedure | Autologous osteochondral graft transplantation is the most common treatment for Hepple V osteochondral lesions of the talus. |
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| autologous osteo-periosteal cylinder graft | Device | Autologous osteo-periosteal cylinder graft is taken from ilium. |
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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 |
| 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. |