MedTrace Logo

New Treatment of Knee Osteoarthritis

NCT06611098 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 134

Last updated 2025-02-26

No results posted yet for this study

Summary

Osteoarthritis (OA) is a chronic degenerative joint disease characterized macroscopically by progressive damage of articular cartilage, joint space narrowing, subchondral bone remodelling, joint marginal osteophyte formation and synovitis. It is also characterized by a decrease of the concentration and molecular weight of the hyaluronic acid in the synovial fluid which ultimately leads to poor viscoelastic properties of synovial fluid and induction of proinflammatory pathways.

The intra-articular injection of viscosupplementation gel (mainly exogenous hyaluronic acid) represents one of the most used therapeutic strategies to treat osteoarthritis symptoms.

Several studies on knee Osteoarthritis, have shown that one or more weekly injection of viscosupplementation gel significantly relieves articular pain and ameliorates mobility and joint function for at least 6 months and more. Repeated courses of intra-articular injections are an effective and safe treatment for knee osteoarthritis symptoms.

Based on studies conducted on intra-articular viscosupplementation gels, the most common side effects expected are local transient and short-lived adverse events such as pain, swelling and arthralgia in the site of administration, which are fully reversible in the days following the injection. Furthermore, such local effects may occur in a minority of cases and are usually treated conservatively with ice, non-steroidal anti-inflammatory drugs, and relative rest.

Conditions

  • Knee Osteoarthristis

Interventions

DEVICE

Viscosupplements

intra-articular injection

Sponsors & Collaborators

  • Symatese

    lead INDUSTRY

Principal Investigators

  • Kristaps KNOHENFELDS · Veselibas Centrs ZIN

  • Kalvis KRASTINS · Kalvja Krastina private practice

  • Manaa Zodelava · JSC "Evex Hospitals" Caraps Medline

  • Nano Emukhvari · LLC Israel-Georgian Medical Research Clinic Healthycore

  • Luba Lagvilava · Consilium Medulla Multiprofile Clinic

  • Ketevan Tsintsadze · LTD HEALTH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-21
Primary Completion
2025-09-30
Completion
2026-03-31

Countries

  • Georgia
  • Latvia

Study Locations

More Related Trials

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 NCT06611098 on ClinicalTrials.gov