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

NCT ID: NCT06527482

Last Updated: 2024-08-06

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-09-01
• Study Completion Date: 2026-09-01

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Autologous Osteoperiosteal Transplantation

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University Third Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Qinwei Guo, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Sports Medicine, Peking University Third Hospital

Locations

Peking University Third Hospital

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Qinwei Guo, MD

Role: CONTACT

guoqinwei@vip.sina.com

+86 18601129252

Qixian Shen, MD

Role: CONTACT

bjmusqx@163.com

+86 13318038398

Facility Contacts

Qinwei Guo, MD

Role: primary

guoqinwei@vip.sina.com

18601129252

Other Identifiers

M2023418

Identifier Type: -

Identifier Source: org_study_id