Osteochondral; DefectNCT03347877
Autologous Osteo-periosteal Cylinder Graft Transplantation for Hepple V Osteochondral Lesions of the Talus
A study testing autologous osteo-periosteal cylinder graft transplantation, autologous osteochondral graft transplantation and autologous osteo-periosteal cylinder graft in people with Osteochondral; Defect, run by Peking University Third Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Osteochondral; Defect
- What is being tested?
- autologous osteo-periosteal cylinder graft transplantation, autologous osteochondral graft transplantation and autologous osteo-periosteal cylinder graft
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Clinical Study of Autologous Osteo-periosteal Cylinder Graft Transplantation for Hepple V Osteochondral Lesions of the Talus
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.
Read the 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.
- Conditions
- Osteochondral; Defect
- Being tested
- autologous osteo-periosteal cylinder graft transplantation, autologous osteochondral graft transplantation, autologous osteo-periosteal cylinder graft
- Keywords
- autologous osteo-periosteal cylinder graft, autologous osteochondral graft, randomized controlled trial, Hepple V osteochondral lesions of the talus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autologous osteo-periosteal cylinder graft transplantationProcedure or surgery
Autologous osteo-periosteal cylinder graft transplantation is a novel treatment for Hepple V osteochondral lesions of the talus.
autologous osteochondral graft transplantationProcedure or surgery
Autologous osteochondral graft transplantation is the most common treatment for Hepple V osteochondral lesions of the talus.
autologous osteo-periosteal cylinder graftDevice
Autologous osteo-periosteal cylinder graft is taken from ilium.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: autologous osteochondral graft transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 years
Secondary outcomes (4)
International Cartilage Repair Society(ICRS) score
International Cartilage Repair Society(ICRS) score. The higher score represent the better outcome.
Measured: 4 years
Magnetic Resonance Observation of cartilage repair tissue(MOCART) score
Magnetic Resonance Observation of cartilage repair tissue(MOCART) score. The higher score represent the better outcome.
Measured: 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.
Measured: 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.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2017
- Study start1 Jan 2018
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Osteochondral; DefectStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guo Qinwei, Peking University Third Hospital
- Investigators
- Qinwei Guo, Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03347877
- Sponsor's protocol ID
- PKU-GUO-01
- Status last verified
- Jun 2025
- First submitted
- 15 Nov 2017
- Last updated
- 27 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40828751Deng 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.
PubMed 32041859
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Autologous Osteo-periosteal Cylinder Graft Transplantation for Hepple V Osteochondral Lesions of the Talus
- ClinicalTrials.gov ID
- NCT03347877
- Acronym / sponsor ID
- PKU-GUO-01
- Conditions
- Osteochondral; Defect
- Keywords
- autologous osteo-periosteal cylinder graft, autologous osteochondral graft, randomized controlled trial, Hepple V osteochondral lesions of the talus
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 20 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| autologous bone-periosteal graft | Experimental | Procedure: autologous osteo-periosteal cylinder graft transplantation, Device: autologous osteo-periosteal cylinder graftThe 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 | Active comparator | Procedure: autologous osteochondral graft transplantationThe patients in control group will undergo the surgery of arthroscopic repair Hepple V osteochondral lesions of the talus with autologous osteochondral graft transplantation. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| autologous osteo-periosteal cylinder graft transplantationAutologous osteo-periosteal cylinder graft transplantation is a novel treatment for Hepple V osteochondral lesions of the talus. | Procedure or surgery | autologous bone-periosteal graft |
| autologous osteochondral graft transplantationAutologous osteochondral graft transplantation is the most common treatment for Hepple V osteochondral lesions of the talus. | Procedure or surgery | autologous osteochondral graft |
| autologous osteo-periosteal cylinder graftAutologous osteo-periosteal cylinder graft is taken from ilium. | Device | autologous bone-periosteal graft |
Primary outcome
American Orthopaedic Foot & Ankle Society(AOFAS) ankle-hindfoot score
Time frame: 4 years
American Orthopaedic Foot \& Ankle Society(AOFAS) ankle-hindfoot score. The higher score represent the better outcome.
4 secondary outcomes
International Cartilage Repair Society(ICRS) score
Time frame: 4 years
Magnetic Resonance Observation of cartilage repair tissue(MOCART) score
Time frame: 4 years
Tegner activity level score
Time frame: 4 years
Visual analogue scale
Time frame: 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2025.
- Derived from this study: PubMed 40828751Yang 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.
- Derived from this study: PubMed 32041859Deng 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Qinwei Guo principal investigator
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing autologous osteo-periosteal cylinder graft transplantation, autologous osteochondral graft transplantation and autologous osteo-periosteal cylinder graft in people with Osteochondral; Defect, run by Peking University Third Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 27 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
American Orthopaedic Foot & Ankle Society(AOFAS) ankle-hindfoot score (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03347877, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2025.