Clinical trial NCT05942430: Autologous Costal Osteochondral Transplantation for Talar Osteochondral Lesions
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Articular Cartilage Defect
Keywords: costa
autologous osteochondral transplantation
autologous osteoperiosteal transplantation
osteochondral lesion of the talus
Lead sponsor: The Third Affiliated Hospital of Southern Medical University
Sponsor class: OTHER_GOV
First posted: 2023-07-12
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: 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.

Primary outcomes:
measure: American Orthopedic Foot and Ankle Society (AOFAS) ankle-hindfoot scale score
timeFrame: 24 months after surgery
Secondary outcomes:
measure: American Orthopedic Foot and Ankle Society (AOFAS) ankle-hindfoot scale score
timeFrame: 3, 6, 12 months after surgery
measure: International Cartilage Repair Society (ICRS) score
timeFrame: 12 months after surgery
measure: Numeric Rating Scale (NRS) for ankle pain during walking
timeFrame: 3, 6, 12 and 24 months after surgery
measure: Foot and Ankle Ability Measure (FAAM) ADL subscale
timeFrame: 12 and 24 months after surgery
measure: Foot and Ankle Ability Measure (FAAM) Sports subscale
timeFrame: 12 and 24 months after surgery
measure: Tegner score
timeFrame: 12 and 24 months after surgery
measure: Patients' satisfaction degree
timeFrame: 24 months after surgery
measure: Bone union
timeFrame: 3 months after surgery or later
measure: Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) score
timeFrame: 12 and 24 months after surgery
measure: Numeric Rating Scale (NRS) for donor-site pain
timeFrame: 1, 2, 3, 6, 12 and 24 months after surgery
measure: Any other complications
timeFrame: 1, 2, 3, 6, 12 and 24 months after surgery
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The Third Affiliated Hospital of Southern Medical University
state: Guangdong
Study officials:
affiliation: The Third Affiliated Hospital of Southern Medical University
name: Canjun Zeng, PhD
role: PRINCIPAL_INVESTIGATOR
References: