Autologous Costal Osteochondral Transplantation for Talar Osteochondral Lesions

NCT05942430 | Recruiting

• 2 other identifiers: 2023-Lunshen-017YL202203
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Keywords

costa; autologous osteochondral transplantation; autologous osteoperiosteal transplantation; osteochondral lesion of the talus

Outcome Measures

Primary Outcomes (1)

• American Orthopedic Foot and Ankle Society (AOFAS) ankle-hindfoot scale score

  0-100

  24 months after surgery

Secondary Outcomes (11)

• American Orthopedic Foot and Ankle Society (AOFAS) ankle-hindfoot scale score

  3, 6, 12 months after surgery

• International Cartilage Repair Society (ICRS) score

  12 months after surgery

• Numeric Rating Scale (NRS) for ankle pain during walking

  3, 6, 12 and 24 months after surgery

• Foot and Ankle Ability Measure (FAAM) ADL subscale

  12 and 24 months after surgery

• Foot and Ankle Ability Measure (FAAM) Sports subscale

  12 and 24 months after surgery

Study Arms (2)

The costa group

EXPERIMENTAL

Autologous costal osteochondral transplantation

Procedure: Autologous costal osteochondral transplantation

The ilium group

ACTIVE COMPARATOR

Autologous iliac osteoperiosteal transplantation

Procedure: Autologous iliac osteoperiosteal transplantation

Interventions

Autologous costal osteochondral transplantation 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 costa group

Autologous iliac osteoperiosteal transplantation 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.

The ilium group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Third Affiliated Hospital of Southern Medical University: lead

Study Sites (1)

The Third Affiliated Hospital of Southern Medical University

Guangzhou, Guangdong, 510630, China

RECRUITING

Study Officials

• Canjun Zeng, PhD

  The Third Affiliated Hospital of Southern Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hao Guo, MD

CONTACT

+8617612003968; 416363977@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Department of Foot and Ankle Surgery

Study Record Dates

• First Submitted: June 18, 2023
• First Posted: July 12, 2023
• Study Start: September 1, 2023
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028
• Last Updated: September 6, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)