Recruiting

RF TKA

Sponsor:

McGill University Health Centre/Research Institute of the McGill University Health Centre

Code:

NCT03758300

Conditions

Knee Osteoarthritis

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

Radiofrequency

Study Details

Brief summary:

The purpose of this study is to compare the effects of the radiofrequency applied to the sensory innervation of the knee, with respect to a control group (standard therapy), in a prehabilitation program aiming to improve the functional recovery of patients undergoing TKA.

In the present study, the investigators hypothesize that participants treated with radiofrequency 4-6 weeks before the surgery, should be able to effectively accomplish the prehabilitation program and, therefore, have a faster recovery of their functional status in the post operative period , compared with the control group (That use the present state of the art approach)

Conditions

Knee Osteoarthritis

Study ID

NCT03758300

Start date

Dec 1, 2017

Status verified date

Aug, 2018

Completion date

Dec 31, 2018

Anticipated

Primary completion date

Dec 31, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Chronic knee pain, with Dynamic VAS ≥ 5
  • Scheduled for elective total knee arthroplasty
  • Functional impairment due to pain because of knee osteoarthritis
  • Taking medications to control the pain.
  • Ability to perform the 6 MWT.

Exclusion Criteria:

  • ASA physical status > 3
  • Morbid obesity (BMI >40)
  • Revision of total knee arthroplasty
  • Mayor neuropsychiatric disease
  • Mayor cardiac, renal or hepatic failure
  • Anemia (hematocrit <30%)
  • Immunosuppression
  • Rheumatoid arthritis
  • Allergy to opioids, to local anesthetics or other medications used in the study,
  • Chronic regular use of large doses of opioids (>20mg equivalent of morphine/day) or sedatives
  • Unwillingness to have spinal anesthesia
  • History of recent drug abuse
  • Contraindication to receive regional anesthesia (e.g. coagulation defect)
  • Inability to walk before the surgery
  • Inability to perform physical tasks
  • Contraindications to physical exercise and training
  • Prior mayor knee surgery
  • Connective tissue diseases affecting the knee
  • Serious neurologic disorders
  • Injection with steroids or hyaluronic acids during the previous 3 months
  • Active sciatic pain
  • Anticoagulant medications

Study Design

Enrollment

48 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Radiofrequency group

In this group patients will receive in a sterile fashion continuous radiofrequency for 4 minutes to the 3 genicular nerves in the operative knee as well as Pulsed Radiofrequency at 42 degrees celsius, for 4 minutes (60-70 volts) to the saphenous nerve and the nerve to the Vastus Medialis, at the level of the adductor canal. The procedure is done under local anesthesia on an ambulatory basis. After the radiofrequency, Ropivacaine 0.5% 5 ml is injected to each one of the nerves, along with 5 milligrams of Methylprednisolone to each nerve. Once the procedure is completed (takes about 20 minutes), patients will be observed in the preoperative program facility for 30 minutes and then discharged home.

sham comparator: Control (Sham Radiofrequency) group

In this group patients will receive injections of the local anesthetic and steroids in the same anatomical locations, without activating the radiofrequency generator.

Interventions

Radiofrequency

See previous page

Primary outcome measure

  • change of 15% of the total distance walked during a 6MWT [ Time Frame: 18 weeks ]

Central Contacts and Locations

Locations

Montreal General Hospital

Recruiting

Montreal, Quebec, Canada, H3A 1A1

Contacts

JF Asenjo, MD

514) 934-1934jfasenjog@yahoo.com

Principal Investigator:

JF Asenjo, MD

More Information

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Last update posted

Nov 29, 2018

Last verified

Aug, 2018

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McGill University Health Centre/Research Institute of the McGill University Health Centre on 2018-11-29.