Development of Biomedical Technology for the Treatment of Ankle Cartilage Using Injectable Biocomposite Hydrogel
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|ClinicalTrials.gov Identifier: NCT06028763|
Recruitment Status : Recruiting
First Posted : September 8, 2023
Last Update Posted : November 29, 2023
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.
|Condition or disease||Intervention/treatment||Phase|
|Ankle Osteoarthritis||Procedure: Injection of biocomposite hydrogel into ankle's cartilage lesion under arthroscopic control Procedure: Microfracture of ankle's cartilage lesion under arthroscopic control||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||
40 participants will divide into 2 groups main and control. Main group (n=20): implantation of heparin-conjugated fibrin hydrogel with autologous MSCs and growth factors (TGF-β1 and BMP-4) into the cartilage defect during arthroscopy.
Control group (n=20): arthroscopic debridement of the joint with microfracturing (traditional method of treatment).
|Masking:||None (Open Label)|
|Official Title:||Development of Biomedical Technology for the Treatment of Ankle Cartilage Using Injectable Biocomposite Hydrogel|
|Actual Study Start Date :||July 1, 2023|
|Estimated Primary Completion Date :||October 29, 2024|
|Estimated Study Completion Date :||November 1, 2025|
Experimental: Group 1 (main)
Treatment consists of 2 stages. 1 stage starts with lipoaspiration of subcutaneous adipose tissue from patients. This tissue will then undergo Mesenchymal Stem Cells (MSC) isolation, cultivation and become a biocomposite hydrogel with growth factors. The 2 stage involves ankle joint arthroscopy using the hydrogel for cartilage therapy. To ensure proper hydrogel fixation, we'll clean cartilage remnants, remove fibrous tissue, and create 10mm deep, 2.5mm diameter microperforations. Cartilage donor site prep during arthroscopy will remove non-viable tissue and establish communication with underlying bone marrow. After stopping bleeding, heparin-conjugated fibrin hydrogel with MSCs and growth factors (TGF-β1 and BMP-4) will be implanted using epinephrine-soaked gauze. Hydrogel gels in 3-5 mins. Ankle joint movement tests will confirm successful implantation. Joint stability, articular congruence, and joint condition will be inspected.
Procedure: Injection of biocomposite hydrogel into ankle's cartilage lesion under arthroscopic control
Surgical treatment involves the use of an injectable biocomposite hydrogel containing autologous mesenchymal stem cells (MSCs), adipose tissue-derived cells, and chondroinductive growth factors (TGF-β1 and BMP-4) under arthroscopic control
Active Comparator: Group 2 (control)
Patients from control group will undergo arthroscopic debridement of the joint with microfracturing (traditional method of treatment).
Procedure: Microfracture of ankle's cartilage lesion under arthroscopic control
Microfracture involves creating tiny perforations in the damaged cartilage, exposing the underlying bone. This encourages the formation of a healing response, where blood and bone marrow cells fill the holes, forming a repair tissue known as fibrocartilage. This newly formed tissue aims to improve joint function and alleviate symptoms associated with cartilage damage. The procedure is performed under arthroscopic guidance, allowing for precise targeting of the lesion while minimizing trauma to the surrounding tissues.
- The American Orthopedic Foot and Ankle Score [ Time Frame: 6; 12 months after surgery ]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.
- Visual Analogue Scale [ Time Frame: 6; 12 months after surgery ]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).
- Magnetic resonance imaging of ankle [ Time Frame: 6; 12 months after surgery ]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.
- Complete Blood Count [ Time Frame: 5 days after surgery ]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
- C-reactive protein [ Time Frame: 5 days after surgery ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06028763
|Contact: Dina Saginova, PhDfirstname.lastname@example.org|
|Contact: Meruyert Makhmetova, PhD Studentemail@example.com|
|Center of National Scientific center Of Traumatology and Orthopedics named after academician N.D. Batpenov||Recruiting|
|Astana, Kazakhstan, Z00P5Y5|
|Contact: Olzhas Bekarissov, PhD +77172547717 firstname.lastname@example.org|