Introduction:
This prospective clinical study aims to investigate the effectiveness of heparin-conjugated gel in treating patients with ankle joint cartilage lesions and to compare its outcomes with the traditional method of microfracture. The study aims to provide valuable insights into novel treatment options for cartilage repair.
Study Design and Participants:
The study plans to enroll 40 male and female patients aged 18 to 65 years with localized defects in the articular cartilage of the talus bone (Outerbridge II-IV) within the ankle joint. Participants will be evenly divided into two groups: the main group and the control group, each comprising 20 participants.
Interventions:
Main Group:
In the main group, participants will undergo a comprehensive two-stage treatment approach:
Stage 1 - Biocomposite Hydrogel Preparation:
Subcutaneous adipose tissue will be collected from patients with signs of ankle joint osteoarthritis through lipoaspiration. The extracted tissue will be transferred to the Kazakh National Center of Biotechnology (Astana, Kazakhstan) for the isolation and cultivation of mesenchymal stromal cells (MSCs). A biocomposite hydrogel, containing MSCs and growth factors (TGF-β1 and BMP-4), will be obtained.
Stage 2 - Arthroscopic Cartilage Therapy:
Participants will undergo arthroscopy of the ankle joint. A heparin-conjugated fibrin hydrogel enriched with MSCs and growth factors will be applied to treat cartilage pathology.
Control Group:
The control group will receive the standard microfracture procedure for ankle cartilage lesion under arthroscopic control.
Follow-Up and Safety Assessment:
A 12-month follow-up period will be implemented to assess short-term and potential mid-term effects. Safety assessment of the heparin-conjugated hydrogel will be based on clinical wound healing assessment, local joint changes, and laboratory data (ESR, white blood cell count, C-reactive protein) 5-7 days post-surgery.
Clinical Evaluation:
The therapeutic efficacy of the heparin-conjugated hydrogel will be evaluated using clinical scales and questionnaires, including the American Orthopedic Foot and Ankle Score (AOFAS) and Visual Analogue Scale (VAS) for joint function and quality of life assessment.
Imaging and Rehabilitation:
Prior to surgery, patients will undergo magnetic resonance imaging (MRI) for defect confirmation and dimension assessment using The Magnetic Resonance Observation of Cartage Repair Tissue (MOCART) scale. Postoperative rehabilitation will be tailored individually based on defect characteristics and patient progress. Axial load on the operated limb will be limited for 6 weeks. Gradual weight-bearing will occur from the 6th to the 12th week.
Postoperative Monitoring:
Cartilage condition and joint health will be monitored postoperatively. Hydrogel survival and cartilage defect closure will be observed using MRI at 6 and 12 months.
Data Analysis:
Statistical analysis will use Microsoft Excel and Statistica 13.0. Descriptive statistics methods will calculate means (M) for parametric indicators, medians (Me) and interquartile ranges (Q25-Q75) for non-parametric indicators, and standard deviations (SD). The Mann-Whitney and Wilcoxon T criteria will assess quantitative differences. The χ2 criterion will assess qualitative parameters. Significance will be considered at p\<0.05.
Conclusion:
This study's rigorous design aims to contribute to understanding the effectiveness of heparin-conjugated gel for ankle cartilage repair, offering potential improvements over traditional microfracture. Insights gained from this study may lead to enhanced treatment options for patients with cartilage lesions in the ankle joint.
