Autologous Costal Osteochondral Transplantation for Talar Osteochondral Lesions

NCT ID: NCT05942430

Last Updated: 2023-09-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-01
• Study Completion Date: 2028-02-29

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.

Conditions

Articular Cartilage Defect

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

The costa group

Autologous costal osteochondral transplantation

Group Type: EXPERIMENTAL

Autologous costal osteochondral transplantation

Intervention Type: PROCEDURE

Operating 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.

The ilium group

Autologous iliac osteoperiosteal transplantation

Group Type: ACTIVE_COMPARATOR

Autologous iliac osteoperiosteal transplantation

Intervention Type: PROCEDURE

Operating 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.

Interventions

Autologous costal osteochondral transplantation

Operating 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.

Intervention Type: PROCEDURE

Autologous iliac osteoperiosteal transplantation

Operating 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.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Third Affiliated Hospital of Southern Medical University

OTHER_GOV

Sponsor Role: lead

Responsible Party

Canjun Zeng

Director of the Department of Foot and Ankle Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Canjun Zeng, PhD

Role: PRINCIPAL_INVESTIGATOR

The Third Affiliated Hospital of Southern Medical University

Locations

The Third Affiliated Hospital of Southern Medical University

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Hao Guo, MD

Role: CONTACT

416363977@qq.com

+8617612003968

Facility Contacts

Junyan Li

Role: primary

00-86-20-62784067

Other Identifiers

YL202203

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2023-Lunshen-017

Identifier Type: -

Identifier Source: org_study_id