Comparison of Conventional and Cooled Radiofrequency Ablation in Knee Osteoarthritis

NCT ID: NCT06863181

Last Updated: 2025-03-07

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

RECRUITING

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-01

Study Completion Date

2025-08-01

Brief Summary

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The aim of this study was to examine and compare the effects of conventional and cooled radiofrequency ablation on pain and disability levels in patients with knee pain resistant to other treatments due to knee osteoarthritis.

Detailed Description

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Conditions

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Knee Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Conventional Radiofrequency Ablation

Conventional radiofrequency ablation with fluoroscopy

Group Type ACTIVE_COMPARATOR

Radiofrequency ablation

Intervention Type DEVICE

Genicular nerve neurolysis with heat

Cooled Radiofrequency Ablation

Cooled radiofrequency ablation with ultrasound

Group Type EXPERIMENTAL

Radiofrequency ablation

Intervention Type DEVICE

Genicular nerve neurolysis with heat

Interventions

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Radiofrequency ablation

Genicular nerve neurolysis with heat

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Knee pain lasting more than 6 months
* Age between 50 and 80
* Diagnosis of radiographically proven grade III or IV knee osteoarthritis according to the Kellgren-Lawrence Grading Scale, marked narrowing of the medial compartment of the tibiofemoral joint space
* Presence of pain resistant to conservative treatment

* Exercise
* Physical therapy agents
* Use of oral anti-inflammatory agents

Exclusion Criteria

* History of trauma to the knee area
* History of knee surgery
* Presence of systemic inflammatory disease affecting the knee joint
* Presence of peripheral neuropathy or radiculopathy
* Pregnancy
* Hemodynamic instability
* Presence of skin or soft tissue infection at the injection site
* Refusal to participate in the study
* Presence of acute knee pain with accompanying inflammatory findings
* Presence of a serious psychiatric disorder or neurological disease Having received an intra-articular injection within the last 3 months
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ayse Naz Kalem

specialist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Gaziler Physical Medicine and Rehabilitation Training and Research Hospital

Ankara, Çankaya, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Ayşe Naz Kalem Özgen, Specialist

Role: CONTACT

03122911000

Facility Contacts

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Ayşe Naz Kalem Özgen, Asist. Dr.

Role: primary

03122911000

Other Identifiers

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AEŞH-EK-2025-064

Identifier Type: -

Identifier Source: org_study_id

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