NCT07381062

Brief Summary

The aim of this study is to compare between conventional Total Knee Arthroplasty (TKA) and Total Knee Arthroplasty (TKA) combined with intra-operative Genicular Nerve Radio-Frequency Ablation (GNRFA), concerning post-operative functional outcome and pain scores in patients with advanced knee osteoarthritis

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

February 22, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 4, 2024

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

January 24, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 2, 2026

Completed
Last Updated

February 11, 2026

Status Verified

February 1, 2026

Enrollment Period

2 years

First QC Date

January 24, 2026

Last Update Submit

February 8, 2026

Conditions

Post Operative PainFunctional Outcome

Keywords

Radio-Frequency AblationTotal Knee ArthroplastyGenicular nerveTotal knee arthroplasty functional outcome

Outcome Measures

Primary Outcomes (2)

  • Post operative pain

    pain assessment using Visual analogue scale, minimum value is 0 meaning no pain and maximum value is 10 meaning the worst pain, higher score means worse outcome

    6 months post operative

  • Post operative knee functional outcome

    measuring the knee functional outcome post operative using oxford knee score, minimum score is 0 meaning the worse outcome and maximum is 48 meaning the best outcome. higher score means better outcome

    6 months

Study Arms (2)

Control

ACTIVE COMPARATOR

underwent Total knee arthroplasty only

Procedure: Total knee arthroplasty

Genicular nerve radio-frequency ablation

EXPERIMENTAL

underwent Total knee arthroplasty with genicular nerve radio-frequency ablation

Procedure: Total knee arthroplastyProcedure: Genicular nerve radiofrequency ablation

Interventions

Total knee arthroplastyPROCEDURE

Conventional Total knee arthroplasty operation performed

Also known as: knee joint replacement
ControlGenicular nerve radio-frequency ablation
Genicular nerve radiofrequency ablationPROCEDURE

Genicular nerve radiofrequency ablation done with no modifications except being performed with total knee arthroplasty in the same setting

Genicular nerve radio-frequency ablation

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with advanced knee osteoarthritis
  • Both sexes
  • Age from 50-80 years old

You may not qualify if:

  • Patients underwent previous GNRFA
  • Patients underwent previous knee surgery
  • patients requiring constrained knee arthroplasty prosthesis (with extreme deformities)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University

Cairo, Abbassia, 00202, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Arthroplasty, Replacement, Knee

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Arthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Study Officials

  • Assem Mohamed Mahmoud Ahmed, MD

    Ain Shams University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2026

First Posted

February 2, 2026

Study Start

February 22, 2022

Primary Completion

March 4, 2024

Study Completion

October 1, 2024

Last Updated

February 11, 2026

Record last verified: 2026-02

Locations

EG(1)