Total Knee Arthroplasty in Conjunction With Intra-operative Genicular Nerve Radio-Frequency Ablation, A Randomized Controlled Clinical Trial
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Ain Shams University
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- Post operative pain
Overview
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
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 50 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
Control
underwent Total knee arthroplasty only
Intervention: Total knee arthroplasty (Procedure)
Genicular nerve radio-frequency ablation
underwent Total knee arthroplasty with genicular nerve radio-frequency ablation
Intervention: Total knee arthroplasty (Procedure)
Genicular nerve radio-frequency ablation
underwent Total knee arthroplasty with genicular nerve radio-frequency ablation
Intervention: Genicular nerve radiofrequency ablation (Procedure)
Outcomes
Primary Outcomes
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
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
Secondary Outcomes
No secondary outcomes reported