Menu
Recruiting NCT05942430

Autologous Costal Osteochondral Transplantation for Talar Osteochondral Lesions

No phase Interventional Articular Cartilage Defect

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Autologous costal osteochondral transplantation, Autologous iliac osteoperiosteal transplantation.
Who it may be relevant to
Registry conditions: Articular Cartilage Defect. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Procedure 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
  • 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 th

Primary outcome measures

  • American Orthopedic Foot and Ankle Society (AOFAS) ankle-hindfoot scale score [Time frame: 24 months after surgery]
Secondary outcome measures (11)
  • American Orthopedic Foot and Ankle Society (AOFAS) ankle-hindfoot scale score [Time frame: 3, 6, 12 months after surgery]
  • International Cartilage Repair Society (ICRS) score [Time frame: 12 months after surgery]
  • Numeric Rating Scale (NRS) for ankle pain during walking [Time frame: 3, 6, 12 and 24 months after surgery]
  • Foot and Ankle Ability Measure (FAAM) ADL subscale [Time frame: 12 and 24 months after surgery]
  • Foot and Ankle Ability Measure (FAAM) Sports subscale [Time frame: 12 and 24 months after surgery]
  • Tegner score [Time frame: 12 and 24 months after surgery]
  • Patients' satisfaction degree [Time frame: 24 months after surgery]
  • Bone union [Time frame: 3 months after surgery or later]
  • Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) score [Time frame: 12 and 24 months after surgery]
  • Numeric Rating Scale (NRS) for donor-site pain [Time frame: 1, 2, 3, 6, 12 and 24 months after surgery]
  • Any other complications [Time frame: 1, 2, 3, 6, 12 and 24 months after surgery]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

China · 1 center
  • The Third Affiliated Hospital of Southern Medical University — Guangzhou

Identifiers

NCT: NCT05942430 · 2023-Lunshen-017 · YL202203

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗