Osteochondral Lesions of the TalusNCT04950335
Comparison of AOCT and AOPT for the Treatment of Medial Large Cystic OLT
An observational study of Osteochondral Lesions of the Talus, run by Peking University Third Hospital.
Trial summary
Autologous osteoperiosteal transplantation using tissue harvested from the iliac crest is used to treat large cystic osteochondral lesions of the talus. This study is to compare clinical and radiological outcomes between patients undergoing AOPT and those undergoing AOCT for large cystic OLTs. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteochondral Lesions of the Talus
- What is being tested?
- AOPT and AOCT
- Type of treatment
- Surgery or procedure
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2014to 10 Nov 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with symptomatic OLTs who underwent AOPT or AOCTvat our sports medicine institute between March, 2015 and March, 2018
Who may be able to join
- presence of medial large cystic OLTs (>10 mm in diameter) confirmed by preoperative magnetic resonance imaging (MRI)
- patients who underwent either primary AOPT or AOCT
Who cannot join
- small cystic OLTs
- ankle osteoarthritis
- ankle pigmented villonodular synovitis
- prior surgery on the ipsilateral ankle
- injuries or relevant trauma to the affected ankle after surgery
About this study
Official title: Comparison of Autologous Osteoperiosteal and Osteochondral Transplantation for the Treatment of Medial Large Cystic Osteochondral Lesions of the Talus
Autologous osteoperiosteal transplantation using tissue harvested from the iliac crest is used to treat large cystic osteochondral lesions of the talus. This study is to compare clinical and radiological outcomes between patients undergoing AOPT and those undergoing AOCT for large cystic OLTs.
Read the detailed description
From March 2015 to March 2018, 23 patients who underwent AOPT and 23 patients who underwent AOCT to treat large cystic OLTs (>10mm) were retrospectively evaluated. For comparability, the two groups were matched based on their demographics, including sex, age, body mass index, side of injury, follow-up period, and the preoperative cyst volume. Clinical outcomes were assessed using the visual analog scale (VAS), the American Orthopaedic Foot \& Ankle Society (AOFAS) score, and the Tegner score. Donor-site morbidity was recorded according to the symptoms, including pain, stiffness, swelling and discomfort. Radiological outcomes were evaluated using the Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) score, and the International Cartilage Repair Society (ICRS) score was obtained during second-look surgery.
- Conditions
- Osteochondral Lesions of the Talus
- Being tested
- AOPT, AOCT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AOPTProcedure or surgery
The Osteochondral Autograft Transplant System (Arthrex) was used to create donor plugs. Osteoperiosteal grafts were harvested from the ipsilateral anterior superior iliac spine.
AOCTProcedure or surgery
Osteochondral grafts were harvested from the non-weight-bearing zone of the ipsilateral anterolateral distal femur.
| Study group | Role | What they receive |
|---|---|---|
| AOPT | patients underwent AOPT to treat large cystic OLTs (>10mm) Receives: Procedure: AOPT | |
| AOCT | patients underwent AOCT to treat large cystic OLTs (>10mm) Receives: Procedure: AOCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
MOCART
the Magnetic Resonance Observation of Cartilage Repair Tissue score
Measured: two years after sugery
Secondary outcomes (4)
VAS
the visual analog scale
Measured: pre-surgery, two years after sugery
Tegner
the Tegner score
Measured: pre-surgery, two years after sugery
AOFAS
American Orthopaedic Foot \& Ankle Society score
Measured: pre-surgery, two years after sugery
ICRS
the International Cartilage Repair Society score
Measured: one year after sugery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2021
- Study start1 Mar 2014
- Primary completion30 Nov 2017
- Study completion10 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteochondral Lesions of the 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
- Retrospective
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Qinwei Guo, MD, Study chair, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04950335
- Sponsor's protocol ID
- M2021055
- Status last verified
- Jun 2021
- First submitted
- 25 Jun 2021
- Last updated
- 6 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Autologous Osteoperiosteal and Osteochondral Transplantation for the Treatment of Medial Large Cystic Osteochondral Lesions of the Talus
- ClinicalTrials.gov ID
- NCT04950335
- Acronym / sponsor ID
- M2021055
- Conditions
- Osteochondral Lesions of the Talus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Mar 2014 (actual)
- Primary completion
- 30 Nov 2017 (actual)
- Study completion
- 10 Nov 2020 (actual)
- First posted
- 6 Jul 2021 (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.
Autologous osteoperiosteal transplantation using tissue harvested from the iliac crest is used to treat large cystic osteochondral lesions of the talus. This study is to compare clinical and radiological outcomes between patients undergoing AOPT and those undergoing AOCT for large cystic OLTs.
Detailed description
From March 2015 to March 2018, 23 patients who underwent AOPT and 23 patients who underwent AOCT to treat large cystic OLTs (>10mm) were retrospectively evaluated. For comparability, the two groups were matched based on their demographics, including sex, age, body mass index, side of injury, follow-up period, and the preoperative cyst volume. Clinical outcomes were assessed using the visual analog scale (VAS), the American Orthopaedic Foot \& Ankle Society (AOFAS) score, and the Tegner score. Donor-site morbidity was recorded according to the symptoms, including pain, stiffness, swelling and discomfort. Radiological outcomes were evaluated using the Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) score, and the International Cartilage Repair Society (ICRS) score was obtained during second-look surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AOPT | – | Procedure: AOPTpatients underwent AOPT to treat large cystic OLTs (>10mm) |
| AOCT | – | Procedure: AOCTpatients underwent AOCT to treat large cystic OLTs (>10mm) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with symptomatic OLTs who underwent AOPT or AOCTvat our sports medicine institute between March, 2015 and March, 2018
Key inclusion criteria (2 listed)
- presence of medial large cystic OLTs (>10 mm in diameter) confirmed by preoperative magnetic resonance imaging (MRI)
- patients who underwent either primary AOPT or AOCT
Key exclusion criteria (5 listed)
- small cystic OLTs
- ankle osteoarthritis
- ankle pigmented villonodular synovitis
- prior surgery on the ipsilateral ankle
- injuries or relevant trauma to the affected ankle after surgery
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 |
|---|---|---|
| AOPTThe Osteochondral Autograft Transplant System (Arthrex) was used to create donor plugs. Osteoperiosteal grafts were harvested from the ipsilateral anterior superior iliac spine. | Procedure or surgery | AOPT |
| AOCTOsteochondral grafts were harvested from the non-weight-bearing zone of the ipsilateral anterolateral distal femur. | Procedure or surgery | AOCT |
Primary outcome
MOCART
Time frame: two years after sugery
the Magnetic Resonance Observation of Cartilage Repair Tissue score
4 secondary outcomes
VAS
Time frame: pre-surgery, two years after sugery
Tegner
Time frame: pre-surgery, two years after sugery
AOFAS
Time frame: pre-surgery, two years after sugery
ICRS
Time frame: one year after sugery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2021.
- Individual participant dataSharing planned: No
Related trials for Osteochondral Lesions of the Talus
RecruitingPhase 3
A Study of MACI in Patients Aged 17 to 65 Years With Symptomatic Chondral or Osteochondral Defects of the Ankle
Chondral Defect, Articular Cartilage Defect
Active, not recruiting
Clinical Outcome After Episealer Talus Implant in Treatment of Osteochondral Lesion of the Talus
Osteochondral Defect
Active, not recruitingObservational study
Ten Years Follow-up After the Arthroscopic Repair of Osteochondral Lesions of the Talus Via Autologous Matrix-induced Chondrogenesis (AMIC)
Osteochondral Defect of Talus
Enrolling by invitation
Autologous Osteo-periosteal Cylinder Graft Transplantation for Hepple V Osteochondral Lesions of the Talus
Osteochondral; Defect
Recruiting
Microfracture With Platelet Rich Plasma Gel Injection for Osteochondral Lesion of the Talus
Osteochondral Lesion of Talus, Microfractures
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 study chair
Peking University Third Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Osteochondral Lesions of the Talus, run by Peking University Third Hospital.
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 2 inclusion and 5 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: finished, as of the sponsor's last update on 6 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
MOCART (time frame: two years after sugery). 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 Jul 2021.