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Outcome Measures

Primary Outcomes (1)

Reduction in Knee Pain
This measure assesses the change in knee pain as reported by participants using the Visual Analog Scale (VAS). A lower score indicates less pain, signifying an improvement.
3 months post-procedure

Secondary Outcomes (3)

Improvement in Knee Function
Assessed at baseline, 1 month, 3 months, and 6 months post-procedure
Incidence of Procedure-Related Adverse Events
From the time of procedure up to 6 months
Patient Satisfaction with the Procedure
3 months post-procedure

Study Arms (2)

CT-Guided Genicular Nerve Ablation

EXPERIMENTAL

Participants in this arm will undergo genicular nerve ablation using computed tomography (CT) guidance. The procedure involves precise needle placement based on CT imaging to effectively target the genicular nerves responsible for transmitting pain signals from the knee.

Procedure: CT-Guided Genicular Nerve Ablation

Fluoroscopic-Guided Genicular Nerve Ablation

ACTIVE COMPARATOR

Participants in this arm will receive genicular nerve ablation using fluoroscopic guidance. The procedure utilizes real-time fluoroscopy to guide needle placement for the ablation of the genicular nerves.

Procedure: Fluoroscopic-Guided Genicular Nerve Ablation

Interventions

CT-Guided Genicular Nerve AblationProcedure

This procedure involves using computed tomography (CT) imaging to guide the precise placement of a needle for the ablation of genicular nerves in the knee. The goal is to disrupt the pain signals caused by osteoarthritis, providing long-term pain relief. The intervention is performed under local anesthesia and is aimed at patients who have not responded adequately to conservative pain management strategies.

CT-Guided Genicular Nerve Ablation

Fluoroscopic-Guided Genicular Nerve AblationProcedure

MeSH Terms

Conditions

Osteoarthritis, KneeAgnosiaPatient Satisfaction

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesPerceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsTreatment Adherence and Compliance

Study Design

Study Type

interventional

Phase

not applicable

Allocation

RANDOMIZED

Masking

SINGLE

Who Masked

OUTCOMES ASSESSOR

Masking Details

In this randomized controlled trial, a partial blinding strategy is employed where only the outcomes assessors are blinded to intervention group assignments. Given the distinct nature of the CT-guided and fluoroscopic-guided procedures, it is impractical to blind participants and care providers. Operators performing the ablation and participants will be aware of the imaging technique used. However, to ensure unbiased evaluation of clinical outcomes, outcomes assessors will not know participants' group assignments. This measure is crucial for preventing observer bias in assessing primary and secondary outcomes such as pain relief, functional improvement, and patient satisfaction.

Purpose

TREATMENT

Intervention Model

PARALLEL

Sponsor Type

OTHER GOV

Responsible Party

PRINCIPAL INVESTIGATOR

PI Title

Assistant Professor of Diagnostic and Interventional Radiology

Comparative Study of CT and Fluoroscopic Guided Genicular Nerve Ablation in the Treatment of Knee Osteoarthritis

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (2)

CT-Guided Genicular Nerve Ablation

Fluoroscopic-Guided Genicular Nerve Ablation

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (2)

CT-Guided Genicular Nerve Ablation

Fluoroscopic-Guided Genicular Nerve Ablation

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations