Articular Cartilage DefectNCT05942430
Autologous Costal Osteochondral Transplantation for Talar Osteochondral Lesions
A study testing Autologous costal osteochondral transplantation and Autologous iliac osteoperiosteal transplantation in people with Articular Cartilage Defect, run by The Third Affiliated Hospital of Southern Medical University at 1 site in China.
Trial summary
The goal of this clinical trial is to evaluate the effectiveness and safety of autologous costal osteochondral transplantation in the treatment of Hepple Stage V talar osteochondral lesions, compared with autologous osteoperiosteal transplantation. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Articular Cartilage Defect
- What is being tested?
- Autologous costal osteochondral transplantation and Autologous iliac osteoperiosteal transplantation
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2023to Feb 2028
- 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
- Symptomatic Hepple stage V talar osteochondral lesions with a lesion depth ≥5 mm and an AOFAS score ≤80 points;
- Failed conservative treatment for at least 6 months;
- Unilateral talar osteochondral lesions without corresponding lesions on the tibial side;
- Willingness to participate in this clinical trial and signing an informed consent form.
Who cannot join
- Combined with lower limb deformity.
- Combined with hip or knee joint diseases.
- Combined with ipsilateral ankle arthritis with joint space narrowing .
- Diagnosis of gouty arthritis of the ankle joint.
- Combined with osteoporosis (T score <-2.5).
- Other conditions considered inappropriate for participation in this clinical trial by the researchers.
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
The Third Affiliated Hospital of Southern Medical University
Guangzhou, Guangdong, 510630
Junyan Li, 00-86-20-62784067
About this study
Official title: Evaluation of the Effectiveness and Safety of Autologous Costal Osteochondral Transplantation in the Treatment of Talar Osteochondral Lesions: a Randomized Controlled Clinical Trial
The goal of this clinical trial is to evaluate the effectiveness and safety of autologous costal osteochondral transplantation in the treatment of Hepple Stage V talar osteochondral lesions, compared with autologous osteoperiosteal transplantation. The main question it aims to answer is:
- Whether autologous costal osteochondral transplantation can achieve better clinical outcomes and cartilage repair quality with lower donor site morbidity than autologous osteoperiosteal transplantation in the treatment of Hepple Stage V talar osteochondral lesions.
Participants will be randomly assigned to the intervention group (undergoing autologous costal osteochondral transplantation) or the control group (undergoing autologous osteoperiosteal transplantation). Both groups of participants will receive the same postoperative rehabilitation process and follow-up evaluation.
- Conditions
- Articular Cartilage Defect
- Being tested
- Autologous costal osteochondral transplantation, Autologous iliac osteoperiosteal transplantation
- Keywords
- costa, autologous osteochondral transplantation, autologous osteoperiosteal transplantation, osteochondral lesion of the talus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous costal osteochondral transplantationProcedure or surgery
Operating steps:
- Arthroscopic examination of the size and location of the talar osteochondral lesion;
- Make a transverse incision (approximately 4 cm long) at the osteochondral junction of the fifth or sixth rib, and harvest an osteochondral column from the rib;
- Thoroughly remove the talar osteochonral lesion through arthrotomy or Chevron osteotomy of the medial malleolus;
- Trim the autograft according to the size of the lesion;
- Fill the peri-lesion cavity with cancellous bone, and finally embed the costal osteochondral autograft into the talar defect, ensuring that the cartilage surface of the transplant to be flush with the normal talar cartilage around it;
- Suture the joint capsule or reduct and fix the medial malleolus, and close the incision layer by layer.
Autologous iliac osteoperiosteal transplantationProcedure or surgery
Operating steps:
- Arthroscopic examination of the size and location of the talar osteochondral lesion;
- Make an incision along the anterior iliac crest. At the time of exposure, pay attention not to damage the periosteum. Obtain a cylindrical osteoperiosteal column by an appropriate-sized harvester tube.
- Thoroughly remove the talar osteochonral lesion through arthrotomy or Chevron osteotomy of the medial malleolus;
- Fill the peri-lesion cavity with cancellous bone, and finally embed the iliac osteoperiosteal autograft into the talar defect, ensuring that the periosteum surface of the transplant to be flush with the normal talar cartilage around it;
- Suture the joint capsule or reduct and fix the medial malleolus, and close the incision layer by layer.
| Study group | Role | What they receive |
|---|---|---|
| The costa group | Experimental | Autologous costal osteochondral transplantation Receives: Procedure: Autologous costal osteochondral transplantation |
| The ilium group | Active comparator | Autologous iliac osteoperiosteal transplantation Receives: Procedure: Autologous iliac osteoperiosteal transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
American Orthopedic Foot and Ankle Society (AOFAS) ankle-hindfoot scale score
0-100
Measured: 24 months after surgery
Secondary outcomes (11)
American Orthopedic Foot and Ankle Society (AOFAS) ankle-hindfoot scale score
0-100
Measured: 3, 6, 12 months after surgery
International Cartilage Repair Society (ICRS) score
0-12; based on arthroscopic examination
Measured: 12 months after surgery
Numeric Rating Scale (NRS) for ankle pain during walking
0-10
Measured: 3, 6, 12 and 24 months after surgery
Foot and Ankle Ability Measure (FAAM) ADL subscale
0-100
Measured: 12 and 24 months after surgery
Foot and Ankle Ability Measure (FAAM) Sports subscale
0-100
Measured: 12 and 24 months after surgery
Tegner score
0-10
Measured: 12 and 24 months after surgery
Patients' satisfaction degree
0-10
Measured: 24 months after surgery
Bone union
Based on computed tomography scan
Measured: 3 months after surgery or later
Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) score
0-100; based on magnetic resonance imaging
Measured: 12 and 24 months after surgery
Numeric Rating Scale (NRS) for donor-site pain
0-10
Measured: 1, 2, 3, 6, 12 and 24 months after surgery
Any other complications
Any other complications
Measured: 1, 2, 3, 6, 12 and 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 posted12 Jul 2023
- Study start1 Sep 2023
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Articular Cartilage DefectStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Third Affiliated Hospital of Southern Medical University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Canjun Zeng, The Third Affiliated Hospital of Southern Medical University
- Investigators
- Canjun Zeng, PhD, Principal investigator, The Third Affiliated Hospital of Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05942430
- Sponsor's protocol ID
- 2023-Lunshen-017
- Other IDs
- YL202203
- Status last verified
- Sep 2023
- First submitted
- 18 Jun 2023
- Last updated
- 6 Sep 2023
- Results posted
- 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 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness and Safety of Autologous Costal Osteochondral Transplantation in the Treatment of Talar Osteochondral Lesions: a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05942430
- Acronym / sponsor ID
- 2023-Lunshen-017
- Conditions
- Articular Cartilage Defect
- Keywords
- costa, autologous osteochondral transplantation, autologous osteoperiosteal transplantation, osteochondral lesion of the talus
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- The Third Affiliated Hospital of Southern Medical UniversityOther government
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 12 Jul 2023 (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 evaluate the effectiveness and safety of autologous costal osteochondral transplantation in the treatment of Hepple Stage V talar osteochondral lesions, compared with autologous osteoperiosteal transplantation. The main question it aims to answer is:
- Whether autologous costal osteochondral transplantation can achieve better clinical outcomes and cartilage repair quality with lower donor site morbidity than autologous osteoperiosteal transplantation in the treatment of Hepple Stage V talar osteochondral lesions.
Participants will be randomly assigned to the intervention group (undergoing autologous costal osteochondral transplantation) or the control group (undergoing autologous osteoperiosteal transplantation). Both groups of participants will receive the same postoperative rehabilitation process and follow-up evaluation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The costa group | Experimental | Procedure: Autologous costal osteochondral transplantationAutologous costal osteochondral transplantation |
| The ilium group | Active comparator | Procedure: Autologous iliac osteoperiosteal transplantationAutologous iliac osteoperiosteal transplantation |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Symptomatic Hepple stage V talar osteochondral lesions with a lesion depth ≥5 mm and an AOFAS score ≤80 points;
- Failed conservative treatment for at least 6 months;
- Unilateral talar osteochondral lesions without corresponding lesions on the tibial side;
- Willingness to participate in this clinical trial and signing an informed consent form.
Key exclusion criteria (6 listed)
- Combined with lower limb deformity.
- Combined with hip or knee joint diseases.
- Combined with ipsilateral ankle arthritis with joint space narrowing .
- Diagnosis of gouty arthritis of the ankle joint.
- Combined with osteoporosis (T score <-2.5).
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 costal osteochondral transplantationOperating steps: 1. Arthroscopic examination of the size and location of the talar osteochondral lesion; 2. Make a transverse incision (approximately 4 cm long) at the osteochondral junction of the fifth or sixth rib, and harvest an osteochondral column from the rib; 3. Thoroughly remove the talar osteochonral lesion through arthrotomy or Chevron osteotomy of the medial malleolus; 4. Trim the autograft according to the size of the lesion; 5. Fill the peri-lesion cavity with cancellous bone, and finally embed the costal osteochondral autograft into the talar defect, ensuring that the cartilage surface of the transplant to be flush with the normal talar cartilage around it; 6. Suture the joint capsule or reduct and fix the medial malleolus, and close the incision layer by layer. | Procedure or surgery | The costa group |
| Autologous iliac osteoperiosteal transplantationOperating steps: 1. Arthroscopic examination of the size and location of the talar osteochondral lesion; 2. Make an incision along the anterior iliac crest. At the time of exposure, pay attention not to damage the periosteum. Obtain a cylindrical osteoperiosteal column by an appropriate-sized harvester tube. 3. Thoroughly remove the talar osteochonral lesion through arthrotomy or Chevron osteotomy of the medial malleolus; 4. Fill the peri-lesion cavity with cancellous bone, and finally embed the iliac osteoperiosteal autograft into the talar defect, ensuring that the periosteum surface of the transplant to be flush with the normal talar cartilage around it; 5. Suture the joint capsule or reduct and fix the medial malleolus, and close the incision layer by layer. | Procedure or surgery | The ilium group |
Primary outcome
American Orthopedic Foot and Ankle Society (AOFAS) ankle-hindfoot scale score
Time frame: 24 months after surgery
0-100
11 secondary outcomes
American Orthopedic Foot and Ankle Society (AOFAS) ankle-hindfoot scale score
Time frame: 3, 6, 12 months after surgery
International Cartilage Repair Society (ICRS) score
Time frame: 12 months after surgery
Numeric Rating Scale (NRS) for ankle pain during walking
Time frame: 3, 6, 12 and 24 months after surgery
Foot and Ankle Ability Measure (FAAM) ADL subscale
Time frame: 12 and 24 months after surgery
Foot and Ankle Ability Measure (FAAM) Sports subscale
Time frame: 12 and 24 months after surgery
Tegner score
Time frame: 12 and 24 months after surgery
Patients' satisfaction degree
Time frame: 24 months after surgery
Bone union
Time frame: 3 months after surgery or later
Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) score
Time frame: 12 and 24 months after surgery
Numeric Rating Scale (NRS) for donor-site pain
Time frame: 1, 2, 3, 6, 12 and 24 months after surgery
Any other complications
Time frame: 1, 2, 3, 6, 12 and 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 6 Sep 2023.
- 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.
Canjun Zeng, PhD principal investigator
The Third Affiliated Hospital of Southern Medical University
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 costal osteochondral transplantation and Autologous iliac osteoperiosteal transplantation in people with Articular Cartilage Defect, run by The Third Affiliated Hospital of Southern Medical University 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 6 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 6 Sep 2023. 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 Hao Guo, MD (+8617612003968, 416363977@qq.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 (AOFAS) ankle-hindfoot scale score (time frame: 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 Sep 2023.