Autologous Costal Osteochondral Transplantation for Talar Osteochondral Lesions

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorThe Third Affiliated Hospital of Southern Medical University

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Autologous costal osteochondral transplantation

    Procedure/Surgery

    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.

  • Autologous iliac osteoperiosteal transplantation

    Procedure/Surgery

    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.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: The costa groupExperimental treatment 1 intervention
Group B: The ilium groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

0-100

Time frame
24 months after surgery

Secondary outcomes

1

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

0-100

Time frame
3, 6, 12 months after surgery
2

International Cartilage Repair Society (ICRS) score

0-12; based on arthroscopic examination

Time frame
12 months after surgery
3

Numeric Rating Scale (NRS) for ankle pain during walking

0-10

Time frame
3, 6, 12 and 24 months after surgery
4

Foot and Ankle Ability Measure (FAAM) ADL subscale

0-100

Time frame
12 and 24 months after surgery

Other outcomes

Sponsors and contacts

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