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

NCT06087601 | Completed Phase 4

• 1 other identifier: 6/2023
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Osteo Arthritis Knee; Osteoarthritis

Outcome Measures

Primary Outcomes (4)

• NRS

  The numeric rating scale (NRS) is a pain screening tool, commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable"

  7 days after procedure

• NRS

  The numeric rating scale (NRS) is a pain screening tool, commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable"

  30 days after procedure

• NRS

  The numeric rating scale (NRS) is a pain screening tool, commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable"

  3 months after procedure

• NRS

  The numeric rating scale (NRS) is a pain screening tool, commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable"

  6 months after procedure

Secondary Outcomes (12)

• Health Questionnaire (EQ-5D-5L)

  7 days after surgery

• Health Questionnaire (EQ-5D-5L)

  30 days after surgery

• Health Questionnaire (EQ-5D-5L)

  3 months after surgery

• Health Questionnaire (EQ-5D-5L)

  6 months after surgery

• neurological deficits

  7 days after procedures

Study Arms (2)

Sham blocks

ACTIVE COMPARATOR

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

Drug: 0.9% Sodium chloride

Genicular nerve neurolysis

ACTIVE COMPARATOR

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

Drug: 95% ethanol

Interventions

0.9% Sodium chloride DRUG

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

Also known as: Sham block

Sham blocks

95% ethanol DRUG

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

Also known as: neurolisis

Genicular nerve neurolysis

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• suspected or diagnosed opioid dependence syndrome
• active cancer
• dementia

Sponsors & Collaborators

• Poznan University of Medical Sciences: lead

Study Sites (1)

Poznan University of Medical Sciences

Poznan, Poznań, 61-701, Poland

Location

MeSH Terms

Conditions

Osteoarthritis

Interventions

Sodium Chloride; Ethanol

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Alcohols; Organic Chemicals

Study Officials

• Katarzyna Wieczorowska-Tobis, Prof.dr hab

  Poznań University of Medical Sciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Group 1: sham blocks Group 2: genicular nerve neurolysis

Study Record Dates

• First Submitted: July 5, 2023
• First Posted: October 18, 2023
• Study Start: October 17, 2023
• Primary Completion: January 10, 2025
• Study Completion: January 14, 2025
• Last Updated: January 21, 2025

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)