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

NCT06028763 | Unknown

• 1 other identifier: AP19679620
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Cartilage lesions; Osteoarthritis; Mesenchymal stem cells; Ankle arthroscopy

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

• Magnetic resonance imaging of ankle

  6; 12 months after surgery

• Complete Blood Count

  5 days after surgery

• C-reactive protein

  5 days after surgery

Study Arms (2)

Group 1 (main)

EXPERIMENTAL

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

Group 2 (control)

ACTIVE COMPARATOR

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

Interventions

Injection of biocomposite hydrogel into ankle's cartilage lesion under arthroscopic control PROCEDURE

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 1 (main)

Microfracture of ankle's cartilage lesion under arthroscopic control PROCEDURE

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.

Group 2 (control)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

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

Astana, Z00P5Y5, Kazakhstan

RECRUITING

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Central Study Contacts

Dina Saginova, PhD

CONTACT

+77015998758; sa_dina@mail.ru

Meruyert Makhmetova, PhD Student

CONTACT

+77011675975; meruert1995@mail.ru

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: August 31, 2023
• First Posted: September 8, 2023
• Study Start: July 1, 2023
• Primary Completion: October 29, 2024
• Study Completion: November 1, 2025
• Last Updated: November 29, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

KA (1)