Ankle Osteoarthritis Clinical Trial
Official title:
Development of Biomedical Technology for the Treatment of Ankle Cartilage Using Injectable Biocomposite Hydrogel
This study aims to evaluate the effectiveness of heparin-conjugated gel for treating ankle joint cartilage lesions compared to the conventional microfracture method. It involves 40 participants aged 18 to 65 with localized cartilage defects (Outerbridge II-IV) in the ankle's talus bone. Participants will be divided into two groups: the main group and the control group. The main group will undergo a two-stage process. Initially, adipose tissue will be collected via lipoaspiration from osteoarthritis patients. This tissue will be used to isolate mesenchymal stem cells (MSCs) and extract growth factors, resulting in a biocomposite hydrogel. In the second stage, arthroscopy will be performed to apply the hydrogel for cartilage treatment. The control group will undergo standard microfracture surgery, a known cartilage repair method. The study's main objective is to compare heparin-conjugated gel treatment to microfracture in terms of cartilage repair and patient outcomes. A 12-month follow-up will assess short-term and potential mid-term effects. Data will be analyzed using Microsoft Excel and Statistica 13.0 for descriptive and comprehensive statistical analysis. Quantitative indicators will be assessed using appropriate tests (Mann-Whitney, Wilcoxon T, χ2) to determine significant differences between groups. The study addresses key questions: Does heparin-conjugated gel offer better cartilage repair, functional improvement, and pain reduction than microfracture? Does the hydrogel approach better preserve joint integrity and slow degeneration? Are there complications with either method? This study combines cellular and surgical components to explore innovative cartilage lesion treatments. Comparing with microfracture and using a thorough follow-up, it aims to enhance cartilage repair techniques and patient outcomes.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | November 1, 2025 |
Est. primary completion date | October 29, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - patients with a local defect of articular cartilage of the talus bone (Outerbridge II-IV) of the ankle joint; - an area of no more than 3 cm2 for a single defect or 20 cm2 for multiple defects of the cartilaginous tissue of the talus bone of the ankle joint; - voluntary consent to participate in the study. Exclusion Criteria: - age 18< and >65 - progressive osteoarthritis of the ankle joint in the late stages; - synovitis of the ankle joint; - instability of the ankle joint; - BMI<29.9; - presence of non-sanitized foci of chronic infection; - severe mental illnesses (schizophrenia, psycho-organic syndrome); - hormonal osteopathy; - hemiparesis on the side of the proposed operation; - neoplasms of other localizations with or without metastases; - absence (refusal) of voluntary consent to participate in the study. |
Country | Name | City | State |
---|---|---|---|
Kazakhstan | Center of National Scientific center Of Traumatology and Orthopedics named after academician N.D. Batpenov | Astana |
Lead Sponsor | Collaborator |
---|---|
National Scientific Center of Traumatology and Orthopedics named after academician N.D. Batpenov |
Kazakhstan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The American Orthopedic Foot and Ankle Score | The American Orthopedic Foot and Ankle Score (AOFAS) is a widely used outcome measure designed to assess the functional status and pain levels of patients with foot and ankle disorders. It provides a standardized way to quantify the impact of musculoskeletal conditions on patients' daily lives. The AOFAS score involves a questionnaire that includes various domains related to pain, function, and alignment of the foot and ankle. The scale includes nine items that can be divided into three subscales (pain, function and alignment). Pain consists of one item with a maximal score of 40 points, indicating no pain. Function consists of seven items with a maximal score of 50 points, indicating full function. Alignment consists of one item with a maximal score of 10 points, indicating good alignment. The maximal score is 100 points, indicating no symptoms or impairments. | 6; 12 months after surgery | |
Primary | Visual Analogue Scale | The Visual Analog Scale (VAS) is a reliable subjective tool used to assess both acute and chronic pain. Individuals express their pain levels by placing a mark on a 10-centimeter line, visually representing a spectrum ranging from "no pain" to "worst pain". Ratings are derived from self-reported symptoms, where individuals use a single handwritten mark on a 10-centimeter line. This line signifies a spectrum between "no pain" at the left end (0 cm) and the utmost level of pain at the right end (10 cm). | 6; 12 months after surgery | |
Secondary | Magnetic resonance imaging of ankle | To confirm the presence of a cartilage tissue defect, determine its localization and preliminary dimensions, and interpret the results according to The Magnetic Resonance Observation of Cartage Repair Tissue (MOCART) scale. The MOCART classification stands out as one of the commonly employed magnetic resonance scores for assessing postoperative cartilage repair tissue. This score, comprising 9 categories and 29 items, yields a comprehensive evaluation, ultimately generating a cartilage repair tissue score ranging from 0 to 100 points. In this scale, 0 points signify the poorest possible score, while 100 points indicate the most favorable score imaginable. | 6; 12 months after surgery | |
Secondary | Complete Blood Count | A Complete Blood Count (CBC) is a comprehensive blood test that evaluates various components of blood, including red blood cells, white blood cells, and platelets. It provides essential information about the health and composition of the blood. In your case, you're particularly interested in assessing the level of erythrocyte sedimentation rate (ESR) and white blood cell count. The ESR measures the rate at which red blood cells settle in a tube of blood and is often used as a marker of inflammation. The white blood cell count measures the number of white blood cells in a given volume of blood and can indicate immune system function and potential infections. By including these specific parameters in the CBC, you aim to gain insights into inflammation levels and immune responses in the body | 5 days after surgery | |
Secondary | C-reactive protein | C-reactive protein (CRP) test plays a crucial role in monitoring the body's response to the surgical procedure. CRP is a protein produced by the liver in response to inflammation. After surgery, the body's immune system reacts to the surgical trauma, causing inflammation at the surgical site. Elevated CRP levels suggest that inflammation is present, which is a normal part of the healing process following surgery. However, extremely high or prolonged CRP levels could indicate excessive or prolonged inflammation, which might raise concerns about potential complications such as infection or poor wound healing. | 5 days after surgery |
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