Development of Biomedical Technology for the Treatment of Ankle Cartilage Using Injectable Biocomposite Hydrogel

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Kazakhstan
Center of National Scientific center Of Traumatology and Orthopedics named after academician N.D. Batpenov
RECRUITING
Astana
Contact Information
Primary
Dina Saginova, PhD
sa_dina@mail.ru
+77015998758
Backup
Meruyert Makhmetova, PhD Student
meruert1995@mail.ru
+77011675975
Time Frame
Start Date: 2023-07-01
Estimated Completion Date: 2025-11-01
Participants
Target number of participants: 40
Treatments
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.
Active_comparator: Group 2 (control)
Patients from control group will undergo arthroscopic debridement of the joint with microfracturing (traditional method of treatment).
Related Therapeutic Areas
Sponsors
Leads: National Scientific Center of Traumatology and Orthopedics named after academician N.D. Batpenov

This content was sourced from clinicaltrials.gov