- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07381062
Total Knee Arthroplasty in Conjunction With Intra-operative Genicular Nerve Radio-Frequency Ablation
Total Knee Arthroplasty in Conjunction With Intra-operative Genicular Nerve Radio-Frequency Ablation, A Randomized Controlled Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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
Including 70 knees randomized using a computer-generated sequence into two groups, the first group underwent TKA combined with GNRFA, and the other group underwent TKA only. All the TKA surgeries were performed by a single surgeon including patients aged from fifty to eighty years with advanced primary knee osteoarthritis from both sexes
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Abbassia
-
Cairo, Abbassia, Egypt, 00202
- Ain shams university
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients with advanced knee osteoarthritis
- Both sexes
- Age from 50-80 years old
Exclusion Criteria:
- Patients underwent previous GNRFA
- Patients underwent previous knee surgery
- patients requiring constrained knee arthroplasty prosthesis (with extreme deformities)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Control
underwent Total knee arthroplasty only
|
Conventional Total knee arthroplasty operation performed
Other Names:
|
|
Experimental: Genicular nerve radio-frequency ablation
underwent Total knee arthroplasty with genicular nerve radio-frequency ablation
|
Conventional Total knee arthroplasty operation performed
Other Names:
Genicular nerve radiofrequency ablation done with no modifications except being performed with total knee arthroplasty in the same setting
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Post operative pain
Time Frame: 6 months post operative
|
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
Time Frame: 6 months
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Assem Mohamed Mahmoud Ahmed, MD, Ain shams university
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Postoperative Complications
- Pathologic Processes
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Pain, Postoperative
- Surgical Procedures, Operative
- Arthroplasty, Replacement
- Arthroplasty
- Orthopedic Procedures
- Plastic Surgery Procedures
- Prosthesis Implantation
- Arthroplasty, Replacement, Knee
Other Study ID Numbers
- FMASU MD39/2022
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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