Osteochondral Lesion of TalusNCT06358807
Microfracture With Platelet Rich Plasma Gel Injection for Osteochondral Lesion of the Talus
A study testing Arthroscopic microfracture with intraoperative local PRP gel injection and Isolated microfracture in people with Osteochondral Lesion of Talus and Microfractures, run by Peking University Third Hospital at 1 site in China.
Trial summary
The goal of this clinical trial is to learn if combined local injection of platelet rich plasma (PRP) gel adds clinical efficacy to isolated arthroscopic microfracture in treatment of osteochondral lesion of the talus (OLT). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Osteochondral Lesion of Talus, Microfractures, Platelet Rich Plasma
- What is being tested?
- Arthroscopic microfracture with intraoperative local PRP gel injection and Isolated microfracture
- Type of treatment
- Injection or infusion, 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 2024to 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
- Chronic ankle pain, diagnosed as osteochondral lesion of the talus;
- Lesion size ≤ 1.5 cm2 or the diameter of the lesion ≤ 1.5 cm;
- 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. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing
Guo Qinwei
About this study
Official title: Clinical Efficacy of Arthroscopic Microfracture Combined With Local Injection of Platelet Rich Plasma Gel in Treatment of Osteochondral Lesion of the Talus: A Randomized Control Trial
The goal of this clinical trial is to learn if combined local injection of platelet rich plasma (PRP) gel adds clinical efficacy to isolated arthroscopic microfracture in treatment of osteochondral lesion of the talus (OLT). The interface integration of the injured area will also be assessed via radiographic follow-up. The main questions it aims to answer are:
- Does arthroscopic microfracture combined with PRP gel injection improve ankle function of participants based on American Orthopedic Foot and Ankle Society (AOFAS) Score?
- Does arthroscopic microfracture combined with PRP gel injection improve interface integration of the injured cartilage on magnetic resonance imaging (MRI)? Researchers will compare arthroscopic microfracture with concomitant local injection of PRP gel to isolated microfracture to see if intraoperative PRP gel injection adds clinical efficacy to isolated arthroscopic microfracture in treatment of OLT.
Read more
Participants will:
- Undergo either isolated arthroscopic microfracture or microfracture with intraoperative injection of PRP gel
- Receive clinical follow-up 3, 6, 12, and 24 months after surgery and answer scales of ankle function assessment
- Take MRI preoperatively and 6, 12 and 24 months after surgery
- Being tested
- Arthroscopic microfracture with intraoperative local PRP gel injection, Isolated microfracture
- Keywords
- Osteochondral Lesion of Talus, Microfractures, Platelet Rich Plasma, Arthroscopic Techniques, Clinical Efficacy
- Medical subject headings
- Fractures, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arthroscopic microfracture with intraoperative local PRP gel injectionProcedure or surgery
Arthroscopic microfracture:
An anteromedial portal and an anterolateral portal are routinely established. A diagnostic arthroscopy is performed. Defects of superficial cartilage, cystic components, and necrotic bone are debrided arthroscopically with curette and shaver to a stable circumferential rim. Microfracture awls are introduced and subchondral channels to 4-6 mm in depth are created, spacing the channels 3 to 5 mm apart across the entire surface of the lesion.
PRP preparation and local injection:
PRP is harvested using a PRP preparation kit via centrifugation. Fifty milliliters of autologous venous blood are drawn from the patient and processed. Platelet count is measured for quality control. On average 4 ml of (range 3-6) PRP is obtained and mixed with thrombin calcium agent in preparation for PRP gel. PRP gel is administered to the injured area using a blunt and long-tip injector, with direct visualization under arthroscope.
Isolated microfractureProcedure or surgery
Arthroscopic microfracture:
An anteromedial portal and an anterolateral portal are routinely established. A diagnostic arthroscopy is performed. Defects of superficial cartilage, cystic components, and necrotic bone are debrided arthroscopically with curette and shaver to a stable circumferential rim. Microfracture awls are introduced and subchondral channels to 4-6 mm in depth are created, spacing the channels 3 to 5 mm apart across the entire surface of the lesion.
| Study group | Role | What they receive |
|---|---|---|
| Microfracture with PRP | Experimental | Arthroscopic microfracture:
An anteromedial portal and an anterolateral portal are routinely established. A diagnostic arthroscopy is performed. Defects of superficial cartilage, cystic components, and necrotic bone are debrided arthroscopically with curette and shaver to a stable circumferential rim. Microfracture awls are introduced and subchondral channels to 4-6 mm in depth are created, spacing the channels 3 to 5 mm apart across the entire surface of the lesion.
PRP preparation and local injection:
PRP is harvested using a PRP preparation kit via centrifugation. Fifty milliliters of autologous venous blood are drawn from the patient and processed. Platelet count is measured for quality control. On average 4 ml of (range 3-6) PRP is obtained and mixed with thrombin calcium agent in preparation for PRP gel. PRP gel is administered to the injured area using a blunt and long-tip injector, with direct visualization under arthroscope. Receives: Procedure: Arthroscopic microfracture with intraoperative local PRP gel injection |
| Isolated microfracture | Active comparator | Arthroscopic microfracture:
An anteromedial portal and an anterolateral portal are routinely established. A diagnostic arthroscopy is performed. Defects of superficial cartilage, cystic components, and necrotic bone are debrided arthroscopically with curette and shaver to a stable circumferential rim. Microfracture awls are introduced and subchondral channels to 4-6 mm in depth are created, spacing the channels 3 to 5 mm apart across the entire surface of the lesion. Receives: Procedure: Isolated microfracture |
What is being measured
The primary outcome is the main question the study is designed to answer.
American Orthopedic Foot and Ankle Society Score (AOFAS)
The scale of AOFAS score will be answered by participants during clinic follow-up preoperatively, and 3, 6, 12 and 24 months after surgery. The primary outcome measure will be the AOFAS collected 24 months post-surgery.
Measured: Pre-surgery and 3, 6, 12 and 24 months after surgery
Secondary outcomes (7)
Foot and Ankle Outcome Score (FAOS)
The scale of FAOS score will be answered by participants during clinic follow-up preoperatively, and 3, 6, 12 and 24 months after surgery.
Measured: Pre-surgery and 3, 6, 12 and 24 months after surgery
Ankle Activity Score (AAS)
The scale of AAS score will be answered by participants during clinic follow-up preoperatively, and 3, 6, 12 and 24 months after surgery.
Measured: Pre-surgery and 3, 6, 12 and 24 months after surgery
Visual Analogue Scale (VAS)
The scale of VAS score will be answered by participants during clinic follow-up preoperatively, and 3, 6, 12 and 24 months after surgery.
Measured: Pre-surgery and 3, 6, 12 and 24 months after surgery
Patient Satisfaction
Patient satisfaction will be graded as 0-10 and collected 24 months after surgery.
Measured: Final follow-up (24 months after surgery)
Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART)
MOCART score will be assessed on magnetic resonance imaging 12 and 24 months after surgery.
Measured: Twelve and 24 months after surgery
Return-to-Sport Rate
The rate and time point of participants returning to sports will be continuously followed during clinic follow-up and will be overall collected 24 months after surgery.
Measured: Final follow-up (24 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 (24 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 posted11 Apr 2024
- Study start1 Jan 2024
- Primary completion1 Jan 2025 (estimated)
- Study completion31 Dec 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 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
- NCT06358807
- Sponsor's protocol ID
- M2023438
- Status last verified
- Mar 2024
- First submitted
- 7 Apr 2024
- Last updated
- 20 May 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 20 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy of Arthroscopic Microfracture Combined With Local Injection of Platelet Rich Plasma Gel in Treatment of Osteochondral Lesion of the Talus: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT06358807
- Acronym / sponsor ID
- M2023438
- Keywords
- Osteochondral Lesion of Talus, Microfractures, Platelet Rich Plasma, Arthroscopic Techniques, Clinical Efficacy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 11 Apr 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 learn if combined local injection of platelet rich plasma (PRP) gel adds clinical efficacy to isolated arthroscopic microfracture in treatment of osteochondral lesion of the talus (OLT). The interface integration of the injured area will also be assessed via radiographic follow-up. The main questions it aims to answer are:
- Does arthroscopic microfracture combined with PRP gel injection improve ankle function of participants based on American Orthopedic Foot and Ankle Society (AOFAS) Score?
- Does arthroscopic microfracture combined with PRP gel injection improve interface integration of the injured cartilage on magnetic resonance imaging (MRI)? Researchers will compare arthroscopic microfracture with concomitant local injection of PRP gel to isolated microfracture to see if intraoperative PRP gel injection adds clinical efficacy to isolated arthroscopic microfracture in treatment of OLT.
Participants will:
- Undergo either isolated arthroscopic microfracture or microfracture with intraoperative injection of PRP gel
- Receive clinical follow-up 3, 6, 12, and 24 months after surgery and answer scales of ankle function assessment
- Take MRI preoperatively and 6, 12 and 24 months after surgery
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Microfracture with PRP | Experimental | Procedure: Arthroscopic microfracture with intraoperative local PRP gel injectionArthroscopic microfracture: An anteromedial portal and an anterolateral portal are routinely established. A diagnostic arthroscopy is performed. Defects of superficial cartilage, cystic components, and necrotic bone are debrided arthroscopically with curette and shaver to a stable circumferential rim. Microfracture awls are introduced and subchondral channels to 4-6 mm in depth are created, spacing the channels 3 to 5 mm apart across the entire surface of the lesion. PRP preparation and local injection: PRP is harvested using a PRP preparation kit via centrifugation. Fifty milliliters of autologous venous blood are drawn from the patient and processed. Platelet count is measured for quality control. On average 4 ml of (range 3-6) PRP is obtained and mixed with thrombin calcium agent in preparation for PRP gel. PRP gel is administered to the injured area using a blunt and long-tip injector, with direct visualization under arthroscope. |
| Isolated microfracture | Active comparator | Procedure: Isolated microfractureArthroscopic microfracture: An anteromedial portal and an anterolateral portal are routinely established. A diagnostic arthroscopy is performed. Defects of superficial cartilage, cystic components, and necrotic bone are debrided arthroscopically with curette and shaver to a stable circumferential rim. Microfracture awls are introduced and subchondral channels to 4-6 mm in depth are created, spacing the channels 3 to 5 mm apart across the entire surface of the lesion. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Chronic ankle pain, diagnosed as osteochondral lesion of the talus;
- Lesion size ≤ 1.5 cm2 or the diameter of the lesion ≤ 1.5 cm;
- 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 |
|---|---|---|
| Arthroscopic microfracture with intraoperative local PRP gel injectionArthroscopic microfracture: An anteromedial portal and an anterolateral portal are routinely established. A diagnostic arthroscopy is performed. Defects of superficial cartilage, cystic components, and necrotic bone are debrided arthroscopically with curette and shaver to a stable circumferential rim. Microfracture awls are introduced and subchondral channels to 4-6 mm in depth are created, spacing the channels 3 to 5 mm apart across the entire surface of the lesion. PRP preparation and local injection: PRP is harvested using a PRP preparation kit via centrifugation. Fifty milliliters of autologous venous blood are drawn from the patient and processed. Platelet count is measured for quality control. On average 4 ml of (range 3-6) PRP is obtained and mixed with thrombin calcium agent in preparation for PRP gel. PRP gel is administered to the injured area using a blunt and long-tip injector, with direct visualization under arthroscope. | Procedure or surgery | Microfracture with PRP |
| Isolated microfractureArthroscopic microfracture: An anteromedial portal and an anterolateral portal are routinely established. A diagnostic arthroscopy is performed. Defects of superficial cartilage, cystic components, and necrotic bone are debrided arthroscopically with curette and shaver to a stable circumferential rim. Microfracture awls are introduced and subchondral channels to 4-6 mm in depth are created, spacing the channels 3 to 5 mm apart across the entire surface of the lesion. | Procedure or surgery | Isolated microfracture |
Primary outcome
American Orthopedic Foot and Ankle Society Score (AOFAS)
Time frame: Pre-surgery and 3, 6, 12 and 24 months after surgery
The scale of AOFAS score will be answered by participants during clinic follow-up preoperatively, and 3, 6, 12 and 24 months after surgery. The primary outcome measure will be the AOFAS collected 24 months post-surgery.
7 secondary outcomes
Foot and Ankle Outcome Score (FAOS)
Time frame: Pre-surgery and 3, 6, 12 and 24 months after surgery
Ankle Activity Score (AAS)
Time frame: Pre-surgery and 3, 6, 12 and 24 months after surgery
Visual Analogue Scale (VAS)
Time frame: Pre-surgery and 3, 6, 12 and 24 months after surgery
Patient Satisfaction
Time frame: Final follow-up (24 months after surgery)
Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART)
Time frame: Twelve and 24 months after surgery
Return-to-Sport Rate
Time frame: Final follow-up (24 months after surgery)
Complications
Time frame: Final follow-up (24 months after surgery)
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 20 May 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.
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?
A study testing Arthroscopic microfracture with intraoperative local PRP gel injection and Isolated microfracture in people with Osteochondral Lesion of Talus and Microfractures, 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: looking for participants now, as of the sponsor's last update on 20 May 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?
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?
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?
American Orthopedic Foot and Ankle Society Score (AOFAS) (time frame: Pre-surgery 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 20 May 2024.