Autologous Costal Osteochondral Transplantation for Talar Osteochondral Lesions

Evaluation of the Effectiveness and Safety of Autologous Costal Osteochondral Transplantation in the Treatment of Talar Osteochondral Lesions: a Randomized Controlled Clinical Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Articular Cartilage Defect
• Intervention / Treatment: Procedure: Autologous costal osteochondral transplantation; Procedure: Autologous iliac osteoperiosteal transplantation

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hao Guo, MD; Phone Number: +8617612003968; Email: 416363977@qq.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510630
      • Recruiting
      • The Third Affiliated Hospital of Southern Medical University
      • Contact: Junyan Li; Phone Number: 00-86-20-62784067

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: The costa group; Autologous costal osteochondral transplantation	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.
Active Comparator: The ilium group; Autologous iliac osteoperiosteal transplantation	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
American Orthopedic Foot and Ankle Society (AOFAS) ankle-hindfoot scale score	0-100	24 months after surgery

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: The Third Affiliated Hospital of Southern Medical University
• Investigators: Principal Investigator: Canjun Zeng, PhD, The Third Affiliated Hospital of Southern Medical University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028

Study Registration Dates

• First Submitted: June 18, 2023
• First Submitted That Met QC Criteria: July 3, 2023
• First Posted (Actual): July 12, 2023

Study Record Updates

• Last Update Posted (Actual): September 6, 2023
• Last Update Submitted That Met QC Criteria: September 4, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: costa; autologous osteochondral transplantation; autologous osteoperiosteal transplantation; osteochondral lesion of the talus
• Other Study ID Numbers: 2023-Lunshen-017; YL202203 (Other Grant/Funding Number: The Dean's Fund)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No