Autologous Costal Osteochondral Transplantation for Talar Osteochondral Lesions

Articular Cartilage Defect Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05942430
• Other study ID #: 2023-Lunshen-017
• Secondary ID: YL202203
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: February 2028

Study information

• Verified date: September 2023
• Source: The Third Affiliated Hospital of Southern Medical University
• Contact: Hao Guo, MD
• Phone: +8617612003968
• Email: 416363977[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: February 2028
• Est. primary completion date: February 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Articular Cartilage Defect

Intervention

Procedure:
• Autologous costal osteochondral transplantation
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 transplantation
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.

Locations

Country	Name	City	State
China	The Third Affiliated Hospital of Southern Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
The Third Affiliated Hospital of Southern Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	American Orthopedic Foot and Ankle Society (AOFAS) ankle-hindfoot scale score	0-100	24 months after surgery
Secondary	American Orthopedic Foot and Ankle Society (AOFAS) ankle-hindfoot scale score	0-100	3, 6, 12 months after surgery
Secondary	International Cartilage Repair Society (ICRS) score	0-12; based on arthroscopic examination	12 months after surgery
Secondary	Numeric Rating Scale (NRS) for ankle pain during walking	0-10	3, 6, 12 and 24 months after surgery
Secondary	Foot and Ankle Ability Measure (FAAM) ADL subscale	0-100	12 and 24 months after surgery
Secondary	Foot and Ankle Ability Measure (FAAM) Sports subscale	0-100	12 and 24 months after surgery
Secondary	Tegner score	0-10	12 and 24 months after surgery
Secondary	Patients' satisfaction degree	0-10	24 months after surgery
Secondary	Bone union	Based on computed tomography scan	3 months after surgery or later
Secondary	Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) score	0-100; based on magnetic resonance imaging	12 and 24 months after surgery
Secondary	Numeric Rating Scale (NRS) for donor-site pain	0-10	1, 2, 3, 6, 12 and 24 months after surgery
Secondary	Any other complications	Any other complications	1, 2, 3, 6, 12 and 24 months after surgery