Clinical trial NCT06527482: Autologous Osteoperiosteal Transplantation for the Treatment of Severe Osteochondral Lesions of the Talus
Official title: A Multicenter Prospective Cohort Study of Autologous Osteoperiosteal Transplantation for the Treatment of Severe Osteochondral Lesions of the Talus
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Osteochondral Lesion of Talus
Autologous Osteoperiosteal Transplantation
Keywords: Osteochondral Lesion of Talus
Autologous Osteoperiosteal Transplantation
Arthroscopic Techniques
Clinical Efficacy
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2024-07-30
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Severe OLT patients undergoing autologous osteoperiosteal transplantation that meet the above criteria

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


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.

Primary outcomes:
measure: Foot and Ankle Outcome Score (FAOS)
timeFrame: Pre-surgery and 6 weeks and 3, 6, 12 and 24 months after surgery
Secondary outcomes:
measure: American Orthopedic Foot and Ankle Society Score (AOFAS)
timeFrame: Pre-surgery and 6 weeks and 3, 6, 12 and 24 months after surgery
measure: Visual Analogue Scale (VAS)
timeFrame: Pre-surgery and 6 weeks and 3, 6, 12 and 24 months after surgery
measure: Ankle Activity Score (AAS)
timeFrame: Pre-surgery and 6 weeks and 3, 6, 12 and 24 months after surgery
measure: Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART)
timeFrame: 12 and 24 months after surgery
measure: International Cartilage Repair Society (ICRS)
timeFrame: 12 months after surgery
measure: Complications
timeFrame: Final follow-up (48 months after surgery)
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
Study officials:
affiliation: Department of Sports Medicine, Peking University Third Hospital
name: Qinwei Guo, MD
role: PRINCIPAL_INVESTIGATOR
References: