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NCT Number: NCT06239649

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

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.

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Key information

Age range

40 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Pamukkale University

Denizli, Pamukkale, 20100, Turkey (Türkiye)

Location status: Recruiting

Location contact

Harun Reşit Güngör

CONTACT

[email protected]

532-234-3770 ext. +90

MURAT I KIRBAS, MD

CONTACT

[email protected]

506-783-0083 ext. +90

Murat İbrahim Kırbaş, MD

PRINCIPAL_INVESTIGATOR

Seher İlhan, Ass. Prof.

SUB_INVESTIGATOR

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • Patients with uncontrolled diabetes

Treatment and study plan

Genicular nerve Radiofrequency Ablation block

Procedure

Genicular nerve Radiofrequency Ablation block

Primary outcomes

  1. Pain preoperative

    Time frame: Baseline (preoperatively)

    Visual Analog Scale used to assess pain

  2. Pain postoperative 1

    Time frame: at postoperative sixth weeks

    Visual Analog Scale used to assess pain

  3. Pain postoperative 2

    Time frame: at postoperative twelfth weeks

    Visual Analog Scale used to assess pain

  4. Knee Range of Motion preoperative

    Time frame: Baseline (preoperatively)

    Digital goniometer used to assess knee range of motion

  5. Knee Range of Motion postoperative 1

    Time frame: at postoperative sixth week

    Digital goniometer used to assess knee range of motion

  6. Knee Range of Motion postoperative 2

    Time frame: at postoperative twelfth week

    Digital goniometer used to assess knee range of motion

  7. Quadriceps muscle strength preoperative

    Time frame: Baseline (preoperatively)

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

  8. Quadriceps muscle strength postoperative 1

    Time frame: at postoperative sixth weeks

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

  9. Quadriceps muscle strength postoperative 2

    Time frame: at postoperative twelfth week

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

  10. 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

  11. 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

  12. 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

  13. Performance-based activity limitations-preoperative

    Time frame: Baseline (preoperatively)

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

  14. Performance-based activity limitations-preoperative 1

    Time frame: at postoperative sixth weeks

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

  15. Performance-based activity limitations-preoperative 2

    Time frame: at postoperative twelfth week

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

  16. Quality of life-preoperative

    Time frame: Baseline (preoperatively)

    Short Form-36 (SF-36) is used

  17. Quality of life-preoperative 1

    Time frame: at postoperative sixth weeks

    Short Form-36 (SF-36) is used

  18. Quality of life-preoperative 2

    Time frame: at postoperative twelfth week

    Short Form-36 (SF-36) is used

  19. 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)

Secondary outcomes

  1. Length of operation time

    Time frame: the surgery

    Length of operation time is measured in minutes during the surgery

  2. Amount of blood loss

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

    Amount of blood loss is measured from the suction drainage (unit-milliliters)

  3. postoperative component alignments

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

    Long leg radiographs of the patients are evaluated postoperatively by using a digital orthopedic templating software-Materialise OrthoView (OrthoView version 7, Materialise HQ, Technologielaan 15 3001 Leuven, Belgium).

Study contacts

Contact information is provided by the study sponsor or research team.

HARUN R GUNGOR, MD

CONTACT

[email protected]

258-296-5690 ext. +90

MURAT I KIRBAS, MD

CONTACT

[email protected]

506-783-0083 ext. +90

Sponsors and collaborators

Lead sponsor

Pamukkale University

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Feb 2, 2024
Registry last updated
Jun 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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