The Third Affiliated Hospital of Southern Medical University
Guangzhou, Guangdong, 510630, China
Location status: Recruiting
Recruiting
NCT Number: NCT05942430
Autologous Costal Osteochondral Transplantation for Talar Osteochondral Lesions
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year–60 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Treatment and study plan
Autologous costal osteochondral transplantation
ProcedureOperating 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 transplantation
ProcedureOperating 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.
Primary outcomes
-
American Orthopedic Foot and Ankle Society (AOFAS) ankle-hindfoot scale score
Time frame: 24 months after surgery
0-100
Secondary outcomes
-
American Orthopedic Foot and Ankle Society (AOFAS) ankle-hindfoot scale score
Time frame: 3, 6, 12 months after surgery
0-100
-
International Cartilage Repair Society (ICRS) score
Time frame: 12 months after surgery
0-12; based on arthroscopic examination
-
Numeric Rating Scale (NRS) for ankle pain during walking
Time frame: 3, 6, 12 and 24 months after surgery
0-10
-
Foot and Ankle Ability Measure (FAAM) ADL subscale
Time frame: 12 and 24 months after surgery
0-100
-
Foot and Ankle Ability Measure (FAAM) Sports subscale
Time frame: 12 and 24 months after surgery
0-100
-
Tegner score
Time frame: 12 and 24 months after surgery
0-10
-
Patients' satisfaction degree
Time frame: 24 months after surgery
0-10
-
Bone union
Time frame: 3 months after surgery or later
Based on computed tomography scan
-
Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) score
Time frame: 12 and 24 months after surgery
0-100; based on magnetic resonance imaging
-
Numeric Rating Scale (NRS) for donor-site pain
Time frame: 1, 2, 3, 6, 12 and 24 months after surgery
0-10
-
Any other complications
Time frame: 1, 2, 3, 6, 12 and 24 months after surgery
Any other complications
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
The Third Affiliated Hospital of Southern Medical University
Other Gov
Registry information
Official study title
Evaluation of the Effectiveness and Safety of Autologous Costal Osteochondral Transplantation in the Treatment of Talar Osteochondral Lesions: a Randomized Controlled Clinical Trial
Important dates
- Study start
- 2023
- Primary completion
- 2028
- Study completion
- 2028
- First posted
- Jul 12, 2023
- Registry last updated
- Sep 6, 2023
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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