Development of Biomedical Technology for the Treatment of Ankle Cartilage Using Injectable Biocomposite Hydrogel
NCT ID: NCT06028763
Last Updated: 2023-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2023-07-01
2025-11-01
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
Control group (n=20): arthroscopic debridement of the joint with microfracturing (traditional method of treatment).
TREATMENT
NONE
Study Groups
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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.
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
Group 2 (control)
Patients from control group will undergo arthroscopic debridement of the joint with microfracturing (traditional method of treatment).
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.
Interventions
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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
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
65 Years
ALL
No
Sponsors
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National Scientific Center of Traumatology and Orthopedics named after academician N.D. Batpenov
OTHER_GOV
Responsible Party
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Locations
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Center of National Scientific center Of Traumatology and Orthopedics named after academician N.D. Batpenov
Astana, , Kazakhstan
Countries
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Central Contacts
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Facility Contacts
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Olzhas Bekarissov, PhD
Role: primary
Other Identifiers
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AP19679620
Identifier Type: -
Identifier Source: org_study_id