The Impact of Genicular Nerves Chemical Neurolysis on the Quality of Life of Patients with Advanced Knee Osteoarthritis.

NCT ID: NCT06087601

Last Updated: 2025-01-21

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-17

Study Completion Date

2025-01-14

Brief Summary

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Genicular nerves chemical neurolysis in advanced osteoarthritis of the knee joint.

Detailed Description

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The study aims to assess the safety and effectiveness of regional pain treatment methods and their impact on the quality of life of patients with advanced osteoarthritis of the knee joint.

Conditions

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Osteo Arthritis Knee Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Group 1: sham blocks Group 2: genicular nerve neurolysis
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Sham blocks

US-guided Bilateral genicular nerve block with 0,9% NaCl

Group Type ACTIVE_COMPARATOR

0.9% Sodium chloride

Intervention Type DRUG

us-guided bilateral genicular nerves sham block with 0,5ml 0,9% normal saline

Genicular nerve neurolysis

US-guided Bilateral genicular nerve neurolysis with 0,5ml 95% ethanol

Group Type ACTIVE_COMPARATOR

95% ethanol

Intervention Type DRUG

us-guided bilateral genicular nerves neurolysis with 0,5ml 95% ethanol

Interventions

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0.9% Sodium chloride

us-guided bilateral genicular nerves sham block with 0,5ml 0,9% normal saline

Intervention Type DRUG

95% ethanol

us-guided bilateral genicular nerves neurolysis with 0,5ml 95% ethanol

Intervention Type DRUG

Other Intervention Names

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Sham block neurolisis

Eligibility Criteria

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Inclusion Criteria

* Patients of the Pain Treatment Clinic of the Transfiguration of Jesus Clinical Hospital of the Medical University of Poznań will be qualified for the study
* patients with gonarthrosis who failed to achieve satisfactory pain control (NRS\>3) despite the use of NSAIDs, Paracetamol, and co-analgesics
* Age of patients: from 18 to 110 years of age.
* Caucasian patients can give informed, complete, written consent.

Exclusion Criteria

* suspected or diagnosed opioid dependence syndrome
* active cancer
* dementia
Minimum Eligible Age

18 Years

Maximum Eligible Age

110 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Poznan University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Katarzyna Wieczorowska-Tobis, Prof.dr hab

Role: STUDY_DIRECTOR

Poznań University of Medical Sciences

Locations

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Poznan University of Medical Sciences

Poznan, Poznań, Poland

Site Status

Countries

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Poland

Other Identifiers

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6/2023

Identifier Type: -

Identifier Source: org_study_id

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