NCT04112264

Brief Summary

Radiofrequency ablation of the genicular nerves using ultrasound is safe and effective for treating intractable knee osteoarthritis pain by using either monopolar or bipolar radiofrequency ablation. This technique is based on anatomical studies demonstrating that genicular nerves are accompanied by genicular arteries. Ultrasound-guided RF genicular ablation yielded both significant reductions in knee pain and improvements in functional capacity.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 25, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 2, 2019

Completed
1 year until next milestone

Study Start

First participant enrolled

October 4, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

October 8, 2020

Status Verified

October 1, 2020

Enrollment Period

6 months

First QC Date

September 25, 2019

Last Update Submit

October 7, 2020

Conditions

Chronic Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

  • Osteoarthritis pain

    The mean changes from baseline levels of osteoarthritis pain using visual analogue scale used to measure pain intensity. It is 10 cm scale where 0 cm represent no pain and 10 cm represent the worst pain ever

    basal value, at 1, 4, 12, 24 weeks post procedure

Secondary Outcomes (8)

  • Oxford Knee Score

    basal value, at 1, 4, 12, 24 weeks post procedure

  • The procedure time

    from the start of advancement of the cannula to end of procedure.

  • Patient satisfaction score

    up to 24 weeks post procedure

  • Changes in doses of rescue analgesics

    up to 24 weeks post procedure

  • The incidence of numbness

    up to 24 weeks post procedure

  • +3 more secondary outcomes

Study Arms (2)

Monopolar radiofrequency ablation

EXPERIMENTAL

Patients will receive ultrasound-guided monopolar radiofrequency ablation

Procedure: Monopolar radiofrequency ablation

Bipolar radiofrequency ablation

ACTIVE COMPARATOR

Patients will receive ultrasound-guided bipolar radiofrequency ablation

Procedure: Bipolar radiofrequency ablation

Interventions

Monopolar radiofrequency ablationPROCEDURE

a radiofrequency cannula is advanced under USG guidance towards the nerve. The final position will be confirmed by using nerve stimulator with elicitation of paraesthesia along the area of knee joint supplied by that respected genicular nerve by stimulation at 50 Hz current of \<0.5 mV. The motor stimulation will be negative at all instances. For each genicular nerve, two conventional RF lesions are done for 120s at 80° of temperature using the Neurotherm 1100 RF generator.

Monopolar radiofrequency ablation
Bipolar radiofrequency ablationPROCEDURE

Two radiofrequency cannula are advanced under USG guidance towards the nerve. The final position will be confirmed by using nerve stimulator with elicitation of paraesthesia by stimulation at 50 Hz current of \<0.5 mV. The motor stimulation will be negative at all instances. For each genicular nerve, two conventional RF lesions are done for 120s at 80° of temperature using the Neurotherm 1100 RF generator.

Bipolar radiofrequency ablation

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Radiologic tibiofemoral Osteoarthritis (Kellgren-Lawrence grade 2-4).
  • Patients not responding to other treatments as physiotherapy, oral analgesics, and intraarticular injection with hyaluronic acids or steroids.
  • Patients refused surgery.

You may not qualify if:

  • Patient refusal.
  • Prior knee surgery.
  • Acute knee pain.
  • Intra-articular knee corticosteroid or hyaluronic acid injection in the past 3 months.
  • Connective tissue diseases that affected the knee.
  • Anticoagulant medication use.
  • Local skin infection and sepsis at the site of intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura University

Al Mansurah, DK, 050, Egypt

RECRUITING

Study Officials

  • Sherif A Mousa, MD

    Professor of Anesthesia and Surgical Intensive Care

    STUDY CHAIR

Central Study Contacts

Sherif A Mousa, MD

CONTACT

00201001637298S_abdomousa@yahoo.com

Ola T Abd El-Dayem, MD

CONTACT

00201202811110Olataha2007@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 25, 2019

First Posted

October 2, 2019

Study Start

October 4, 2020

Primary Completion

April 1, 2021

Study Completion

June 1, 2021

Last Updated

October 8, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will share

study protocol Statistical analysis plan Informed consent form

Time Frame
data will be available at the end of study
Access Criteria
data access requests will be reviewed by an external independent review panel. Requestors will be required to sign a data access agreement

Locations

EG(1)