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

NCT06028763 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2023-11-29

No results posted yet for this study

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.

Conditions

  • Ankle Osteoarthritis

Interventions

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

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.

Sponsors & Collaborators

  • National Scientific Center of Traumatology and Orthopedics named after academician N.D. Batpenov

    lead OTHER_GOV

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-01
Primary Completion
2024-10-29
Completion
2025-11-01

Countries

  • Kazakhstan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06028763 on ClinicalTrials.gov