Osteochondral Lesion of TalusNCT06527482
Autologous Osteoperiosteal Transplantation for the Treatment of Severe Osteochondral Lesions of the Talus
An observational study of Osteochondral Lesion of Talus and Autologous Osteoperiosteal Transplantation, run by Peking University Third Hospital at 1 site in China.
Trial summary
The goal of this clinical trial is to establish a multicenter prospective cohort of patients with severe osteochondral lesion of the talus (OLT), evaluate the clinical efficacy of autologous osteoperiosteal transplantation and the incidence of postoperative donor-site morbidity. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Osteochondral Lesion of Talus, Autologous Osteoperiosteal Transplantation
- What is being tested?
- Autologous Osteoperiosteal Transplantation
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2023to 1 Sep 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Severe OLT patients undergoing autologous osteoperiosteal transplantation that meet the above criteria
Who may be able to join
- Chronic ankle pain, diagnosed as Osteochondral Lesions of the Talus (OLT);
- Hepple V OLT on the medial side of the talus or the diameter of the lesion ≥ 8 mm;
- Conservative treatment of at least 3 months fails to relieve symptoms;
- Willingness to voluntarily participate in the trial and to sign informed consent.
Who cannot join
- Varus or valgus deformity of the ankle of more than 5 degrees;
- Grade III injury of the lateral collateral ligament of ankle;
- Chronic synovitis (rheumatoid arthritis, pigmented villous nodular synovitis, etc.);
- Joint fibrosis, stiffness, and significantly restricted range of motion;
- Evidence of moderate to severe knee osteoarthritis on plain radiographs;
- Failure to complete the rehabilitation protocol as required;
- Patient medically not fit for surgery, radiographs or MRI;
- For women, pregnant, planning to be pregnant or lactating.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing
Qinwei Guo, MD, 18601129252, guoqinwei@vip.sina.com
About this study
Official title: A Multicenter Prospective Cohort Study of Autologous Osteoperiosteal Transplantation for the Treatment of Severe Osteochondral Lesions of the Talus
The goal of this clinical trial is to establish a multicenter prospective cohort of patients with severe osteochondral lesion of the talus (OLT), evaluate the clinical efficacy of autologous osteoperiosteal transplantation and the incidence of postoperative donor-site morbidity. The main questions it aims to answer are:
Does autologous osteoperiosteal transplantation have good clinical outcomes in the treatment of severe OLT? Does autologous osteoperiosteal transplantation treat severe OLT with fewer postoperative complications?
Read more
Participants will:
Undergo autologous osteoperiosteal transplantation for OLT Receive clinical follow-up 3, 6, 12, and 24 months after surgery and answer scales of ankle function assessment Take CT and MRI preoperatively and 12 and 24 months after surgery
- Being tested
- Autologous Osteoperiosteal Transplantation
- Keywords
- Osteochondral Lesion of Talus, Autologous Osteoperiosteal Transplantation, Arthroscopic Techniques, Clinical Efficacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Osteoperiosteal TransplantationProcedure or surgery
After full exposure of the lesion, the center of the cystic lesion was determined and drilled perpendicularly using a 2-mm pin. Then, a 4.5-mm cannulated bore was used to drill the lesion until the cyst was reached, and a small bone socket was created. A harvester tube matching the diameter of the cyst was used to enlarge the bone socket with care to avoid damage to the adjacent normal cartilage. The cystic lesion was debrided thoroughly, and the sclerotic wall of the cyst was freshened using a curette. The harvester tube with a matched diameter was driven in to a depth of 15 to 20 mm at the 2-cm proximal part of the anterior superior iliac spine perpendicularly without violation of the lateral wall of the crest. When necessary, small pieces of cancellous bone were also harvested from the iliac crest using a bone curette then grafted into the peripheral area of the cyst to fill up the remaining space of the cyst around the bone socket in the talus.
What is being measured
The primary outcome is the main question the study is designed to answer.
Foot and Ankle Outcome Score (FAOS)
The Foot and Ankle Outcome Score (FAOS) is an extensive tool designed to evaluate the patient's perception of their foot and ankle conditions, with 0 indicating the worst possible outcome, and 100 representing the best possible outcome. The scale of FAOS score will be answered by participants during clinic follow-up preoperatively, and 6 weeks 3, 6, 12 and 24 months after surgery.
Measured: Pre-surgery and 6 weeks and 3, 6, 12 and 24 months after surgery
Secondary outcomes (6)
American Orthopedic Foot and Ankle Society Score (AOFAS)
The AOFAS is a standardized tool used to evaluate the outcomes of treatments for foot and ankle disorders, with 0 indicating severe disability or extreme problems, and 100 indicating no disability or problems.The scale of AOFAS score will be answered by participants during clinic follow-up preoperatively, and 6 weeks 3, 6, 12 and 24 months after surgery.
Measured: Pre-surgery and 6 weeks and 3, 6, 12 and 24 months after surgery
Visual Analogue Scale (VAS)
The Visual Analog Scale (VAS) is a simple and widely used method for assessing the intensity of pain and other subjective experiences, with 0 indicating no pain, and 100 indicating the worst possible pain. The scale of VAS score will be answered by participants during clinic follow-up preoperatively, and 6 weeks 3, 6, 12 and 24 months after surgery.
Measured: Pre-surgery and 6 weeks and 3, 6, 12 and 24 months after surgery
Ankle Activity Score (AAS)
The AAS is a scoring tool to assess sports activity for the ankle joint, with zero point indicating the lowest activity level, and ten points indicating the highest activity level. The scale of AAS score will be answered by participants during clinic follow-up preoperatively, and 6 weeks 3, 6, 12 and 24 months after surgery.
Measured: Pre-surgery and 6 weeks and 3, 6, 12 and 24 months after surgery
Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART)
The Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) score is a grading system used to evaluate the quality of cartilage repair tissue through MRI (Magnetic Resonance Imaging), with 0 indicating poor cartilage repair quality, and 100 indicating excellent cartilage repair quality. MOCART score will be assessed on magnetic resonance imaging 12 and 24 months after surgery.
Measured: 12 and 24 months after surgery
International Cartilage Repair Society (ICRS)
The International Cartilage Repair Society (ICRS) score is a grading system used to assess the condition of articular cartilage, especially in the context of cartilage repair procedures, with 0 indicating poor cartilage repair quality, and 12 indicating excellent cartilage repair quality. ICRS score will be assessed 12 months
Measured: 12 months after surgery
Complications
Complications, including infection,hematoma, stiffness, recurrent ankle pain will be continuously followed during clinic follow-up and will be overall collected 24 months after surgery.
Measured: Final follow-up (48 months after surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2024
- Study start1 Sep 2023
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteochondral Lesion of TalusStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Qinwei Guo, MD, Principal investigator, Department of Sports Medicine, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06527482
- Sponsor's protocol ID
- M2023418
- Status last verified
- Jun 2024
- First submitted
- 25 Jul 2024
- Last updated
- 6 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Prospective Cohort Study of Autologous Osteoperiosteal Transplantation for the Treatment of Severe Osteochondral Lesions of the Talus
- ClinicalTrials.gov ID
- NCT06527482
- Acronym / sponsor ID
- M2023418
- Keywords
- Osteochondral Lesion of Talus, Autologous Osteoperiosteal Transplantation, Arthroscopic Techniques, Clinical Efficacy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 30 Jul 2024 (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 goal of this clinical trial is to establish a multicenter prospective cohort of patients with severe osteochondral lesion of the talus (OLT), evaluate the clinical efficacy of autologous osteoperiosteal transplantation and the incidence of postoperative donor-site morbidity. The main questions it aims to answer are:
Does autologous osteoperiosteal transplantation have good clinical outcomes in the treatment of severe OLT? Does autologous osteoperiosteal transplantation treat severe OLT with fewer postoperative complications?
Participants will:
Undergo autologous osteoperiosteal transplantation for OLT Receive clinical follow-up 3, 6, 12, and 24 months after surgery and answer scales of ankle function assessment Take CT and MRI preoperatively and 12 and 24 months after surgery
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Severe OLT patients undergoing autologous osteoperiosteal transplantation that meet the above criteria
Key inclusion criteria (4 listed)
- Chronic ankle pain, diagnosed as Osteochondral Lesions of the Talus (OLT);
- Hepple V OLT on the medial side of the talus or the diameter of the lesion ≥ 8 mm;
- Conservative treatment of at least 3 months fails to relieve symptoms;
- Willingness to voluntarily participate in the trial and to sign informed consent.
Key exclusion criteria (8 listed)
- Varus or valgus deformity of the ankle of more than 5 degrees;
- Grade III injury of the lateral collateral ligament of ankle;
- Chronic synovitis (rheumatoid arthritis, pigmented villous nodular synovitis, etc.);
- Joint fibrosis, stiffness, and significantly restricted range of motion;
- Evidence of moderate to severe knee osteoarthritis on plain radiographs;
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 Osteoperiosteal TransplantationAfter full exposure of the lesion, the center of the cystic lesion was determined and drilled perpendicularly using a 2-mm pin. Then, a 4.5-mm cannulated bore was used to drill the lesion until the cyst was reached, and a small bone socket was created. A harvester tube matching the diameter of the cyst was used to enlarge the bone socket with care to avoid damage to the adjacent normal cartilage. The cystic lesion was debrided thoroughly, and the sclerotic wall of the cyst was freshened using a curette. The harvester tube with a matched diameter was driven in to a depth of 15 to 20 mm at the 2-cm proximal part of the anterior superior iliac spine perpendicularly without violation of the lateral wall of the crest. When necessary, small pieces of cancellous bone were also harvested from the iliac crest using a bone curette then grafted into the peripheral area of the cyst to fill up the remaining space of the cyst around the bone socket in the talus. | Procedure or surgery | – |
Primary outcome
Foot and Ankle Outcome Score (FAOS)
Time frame: Pre-surgery and 6 weeks and 3, 6, 12 and 24 months after surgery
The Foot and Ankle Outcome Score (FAOS) is an extensive tool designed to evaluate the patient's perception of their foot and ankle conditions, with 0 indicating the worst possible outcome, and 100 representing the best possible outcome. The scale of FAOS score will be answered by participants during clinic follow-up preoperatively, and 6 weeks 3, 6, 12 and 24 months after surgery.
6 secondary outcomes
American Orthopedic Foot and Ankle Society Score (AOFAS)
Time frame: Pre-surgery and 6 weeks and 3, 6, 12 and 24 months after surgery
Visual Analogue Scale (VAS)
Time frame: Pre-surgery and 6 weeks and 3, 6, 12 and 24 months after surgery
Ankle Activity Score (AAS)
Time frame: Pre-surgery and 6 weeks and 3, 6, 12 and 24 months after surgery
Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART)
Time frame: 12 and 24 months after surgery
International Cartilage Repair Society (ICRS)
Time frame: 12 months after surgery
Complications
Time frame: Final follow-up (48 months after surgery)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
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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. This study is not recruiting at the moment.
Qinwei Guo, MD principal investigator
Department of Sports Medicine, 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?
An observational study of Osteochondral Lesion of Talus and Autologous Osteoperiosteal Transplantation, 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 8 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: status not confirmed, as of the sponsor's last update on 6 Aug 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qinwei Guo, MD (+86 18601129252, guoqinwei@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Foot and Ankle Outcome Score (FAOS) (time frame: Pre-surgery and 6 weeks and 3, 6, 12 and 24 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Aug 2024.