Autologous Osteoperiosteal Transplantation for the Treatment of Severe Osteochondral Lesions of the Talus

NCT06527482 | Recruiting

• 1 other identifier: M2023418
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to establish a multicenter prospective cohort of patients with severe osteochondral lesion of the talus (OLT), evaluate the clinical efficacy of autologous osteoperiosteal transplantation and the incidence of postoperative donor-site morbidity. The main questions it aims to answer are: Does autologous osteoperiosteal transplantation have good clinical outcomes in the treatment of severe OLT? Does autologous osteoperiosteal transplantation treat severe OLT with fewer postoperative complications? Participants will: Undergo autologous osteoperiosteal transplantation for OLT Receive clinical follow-up 3, 6, 12, and 24 months after surgery and answer scales of ankle function assessment Take CT and MRI preoperatively and 12 and 24 months after surgery

Conditions

Osteochondral Lesion of Talus; Autologous Osteoperiosteal Transplantation

Keywords

Osteochondral Lesion of Talus; Autologous Osteoperiosteal Transplantation; Arthroscopic Techniques; Clinical Efficacy

Outcome Measures

Primary Outcomes (1)

• Foot and Ankle Outcome Score (FAOS)

  The Foot and Ankle Outcome Score (FAOS) is an extensive tool designed to evaluate the patient's perception of their foot and ankle conditions, with 0 indicating the worst possible outcome, and 100 representing the best possible outcome. The scale of FAOS score will be answered by participants during clinic follow-up preoperatively, and 6 weeks 3, 6, 12 and 24 months after surgery.

  Pre-surgery and 6 weeks and 3, 6, 12 and 24 months after surgery

Secondary Outcomes (6)

• American Orthopedic Foot and Ankle Society Score (AOFAS)

  Pre-surgery and 6 weeks and 3, 6, 12 and 24 months after surgery

• Visual Analogue Scale (VAS)

  Pre-surgery and 6 weeks and 3, 6, 12 and 24 months after surgery

• Ankle Activity Score (AAS)

  Pre-surgery and 6 weeks and 3, 6, 12 and 24 months after surgery

• Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART)

  12 and 24 months after surgery

• International Cartilage Repair Society (ICRS)

  12 months after surgery

Interventions

Autologous Osteoperiosteal Transplantation PROCEDURE

After full exposure of the lesion, the center of the cystic lesion was determined and drilled perpendicularly using a 2-mm pin. Then, a 4.5-mm cannulated bore was used to drill the lesion until the cyst was reached, and a small bone socket was created. A harvester tube matching the diameter of the cyst was used to enlarge the bone socket with care to avoid damage to the adjacent normal cartilage. The cystic lesion was debrided thoroughly, and the sclerotic wall of the cyst was freshened using a curette. The harvester tube with a matched diameter was driven in to a depth of 15 to 20 mm at the 2-cm proximal part of the anterior superior iliac spine perpendicularly without violation of the lateral wall of the crest. When necessary, small pieces of cancellous bone were also harvested from the iliac crest using a bone curette then grafted into the peripheral area of the cyst to fill up the remaining space of the cyst around the bone socket in the talus.

Eligibility Criteria

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

Study Population

Severe OLT patients undergoing autologous osteoperiosteal transplantation that meet the above criteria

You may qualify if:

• Chronic ankle pain, diagnosed as Osteochondral Lesions of the Talus (OLT);
• Hepple V OLT on the medial side of the talus or the diameter of the lesion ≥ 8 mm;
• Conservative treatment of at least 3 months fails to relieve symptoms;
• Willingness to voluntarily participate in the trial and to sign informed consent.

You may not qualify if:

• Varus or valgus deformity of the ankle of more than 5 degrees;
• Grade III injury of the lateral collateral ligament of ankle;
• Chronic synovitis (rheumatoid arthritis, pigmented villous nodular synovitis, etc.);
• Joint fibrosis, stiffness, and significantly restricted range of motion;
• Evidence of moderate to severe knee osteoarthritis on plain radiographs;
• Failure to complete the rehabilitation protocol as required;
• Patient medically not fit for surgery, radiographs or MRI;
• For women, pregnant, planning to be pregnant or lactating.

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, China

RECRUITING

Study Officials

• Qinwei Guo, MD

  Department of Sports Medicine, Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qinwei Guo, MD

CONTACT

+86 18601129252; guoqinwei@vip.sina.com

Qixian Shen, MD

CONTACT

+86 13318038398; bjmusqx@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2024
• First Posted: July 30, 2024
• Study Start: September 1, 2023
• Primary Completion: January 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: August 6, 2024

Record last verified: 2024-06

Locations

CN (1)