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Clinical Trials/NCT06239649
NCT06239649
Recruiting
Not Applicable

The Effect of RF Genicular Nerve Block Applied in the Preoperative Period on Fast-track Total Knee Arthroplasty

Pamukkale University1 site in 1 country60 target enrollmentOctober 19, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Knee Osteoarthritis
Sponsor
Pamukkale University
Enrollment
60
Locations
1
Primary Endpoint
Performance-based activity limitations-preoperative 1
Status
Recruiting
Last Updated
11 months ago

Overview

Brief Summary

In our study, investigators plan to compare the preoperative RF and genicular nerve ablation approach in patients who underwent TKA(Total Knee Arthroplasty) using the Fast-Track protocol in terms of meeting postoperative pain, function and early discharge criteria.

Detailed Description

One of the most important components of surgery using Fast-Track is the application of effective and well-monitored pain treatment. Post-surgical pain negatively affects the patient's early mobilization. Reduction in pain after TKA(Total Knee Arthroplasty) may not only increase short-term functional results but also increase the patient's overall satisfaction. Genicular Nerve Radiofrequency Ablation (GNRFA) is a non-surgical treatment increasingly used in patients with advanced knee osteoarthritis. Previous studies have shown this to be an effective and safe method to reduce pain and improve functionality in this patient population. Neurolysis of genicular nerves with radiofrequency (RF) may be useful to relieve pain and improve both function and quality of life in patients with post-TKA pain. Investigators thought that reducing the pain of patients who underwent TKA with Fast-track in the postoperative period would contribute to early mobilization and therefore rapid functional recovery. As a result of previous studies, investigators know that genicular nerve neurolysis with RF Ablation in the preoperative period provides a reduction in postoperative pain. Investigators routinely apply TKA applications in clinic with Fast-Track. In investigators hospital's algology outpatient clinic, genicular nerve RF ablation is routinely performed under USG or fluoroscopy guidance. In investigators study, investigators plan to compare the preoperative RF and genicular nerve ablation approach in patients who underwent TKA using the Fast-Track protocol in terms of meeting postoperative pain, function and early discharge criteria

Registry
clinicaltrials.gov
Start Date
October 19, 2023
End Date
June 1, 2025
Last Updated
11 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Harun Resit Gungor

Prof. Dr

Pamukkale University

Eligibility Criteria

Inclusion Criteria

  • Being between the ages of 40 and 85,
  • Being able to understand verbal and written information given in Turkish,
  • Being able to speak and understand Turkish,
  • Being subjected to unilateral TKA surgery due to the diagnosis of Primary Knee osteoarthritis

Exclusion Criteria

  • Patients planned for revision knee prosthesis surgery,
  • Patients previously diagnosed with psychiatric disorders,
  • Patients who have undergone major surgery on the extremity where TKA will be applied,
  • Patients with comorbid diseases such as rheumatoid arthritis or cancer,
  • Patients with a score above 3 according to the American Society of Anesthesiologists (ASA) scoring,
  • Patients with neurological diseases that cause functional disability,
  • Patients with flexion limitation of more than 45 degrees and extension limitation of more than 20 degrees,
  • Patients who have to use hypnotic or anxiolytic drugs regularly,
  • Patients with alcohol or drug addiction,
  • Patients with bleeding disorders

Outcomes

Primary Outcomes

Performance-based activity limitations-preoperative 1

Time Frame: at postoperative sixth weeks

30-sec chair-stand test and stair-climb test are used

Quality of life-preoperative

Time Frame: Baseline (preoperatively)

Short Form-36 (SF-36) is used

Knee Range of Motion preoperative

Time Frame: Baseline (preoperatively)

Digital goniometer used to assess knee range of motion

Performance-based activity limitations-preoperative 2

Time Frame: at postoperative twelfth week

30-sec chair-stand test and stair-climb test are used

Pain preoperative

Time Frame: Baseline (preoperatively)

Visual Analog Scale used to assess pain

Knee Range of Motion postoperative 2

Time Frame: at postoperative twelfth week

Digital goniometer used to assess knee range of motion

Quadriceps muscle strength postoperative 2

Time Frame: at postoperative twelfth week

Quadriceps muscle strength is measured (unit=newton(N)) with hand-held dynamometer

Quality of life-preoperative 2

Time Frame: at postoperative twelfth week

Short Form-36 (SF-36) is used

Length of hospital stay

Time Frame: through study completion, an average of 1 year

Length of hospital stay is measured beginning from the hospitalization of the patient and ending at discharge of the patients (unit-hours)

Knee Range of Motion postoperative 1

Time Frame: at postoperative sixth week

Digital goniometer used to assess knee range of motion

Quadriceps muscle strength postoperative 1

Time Frame: at postoperative sixth weeks

Quadriceps muscle strength is measured (unit=newton(N)) with hand-held dynamometer

Patient-reported activity limitations preoperative 2

Time Frame: at postoperative twelfth week

The Western Ontario and McMaster Universities Arthritis Index and Knee injury and Osteoarthritis Outcome Score are used

Performance-based activity limitations-preoperative

Time Frame: Baseline (preoperatively)

30-sec chair-stand test and stair-climb test are used

Pain postoperative 1

Time Frame: at postoperative sixth weeks

Visual Analog Scale used to assess pain

Pain postoperative 2

Time Frame: at postoperative twelfth weeks

Visual Analog Scale used to assess pain

Quadriceps muscle strength preoperative

Time Frame: Baseline (preoperatively)

Quadriceps muscle strength is measured (unit=newton(N)) with hand-held dynamometer

Patient-reported activity limitations preoperative

Time Frame: Baseline (preoperatively)

The Western Ontario and McMaster Universities Arthritis Index and Knee injury and Osteoarthritis Outcome Score are used

Patient-reported activity limitations preoperative 1

Time Frame: at postoperative sixth weeks

The Western Ontario and McMaster Universities Arthritis Index and Knee injury and Osteoarthritis Outcome Score are used

Quality of life-preoperative 1

Time Frame: at postoperative sixth weeks

Short Form-36 (SF-36) is used

Secondary Outcomes

  • Length of operation time(the surgery)
  • Amount of blood loss(through study completion, an average of 1 year)
  • postoperative component alignments(through study completion, an average of 1 year)

Study Sites (1)

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