NCT03758300

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)

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
48

participants targeted

Target at P25-P50 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Dec 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2017

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 20, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

November 29, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

November 29, 2018

Status Verified

August 1, 2018

Enrollment Period

1.1 years

First QC Date

August 20, 2018

Last Update Submit

November 28, 2018

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

  • change of 15% of the total distance walked during a 6MWT

    change of 15% or more in total distance in six minute walk test from baseline

    18 weeks

Secondary Outcomes (4)

  • Change in WOMAC score

    Baseline and 18 weeks

  • Change in knee pain levels assessed by VAS (Dynamic/Static)

    Baseline and 18 weeks

  • Change in amount of daily pain relief medication consumption

    Baseline and 18 weeks

  • Change in total time of the time up and go (TUG) test

    Baseline and 18 weeks

Study Arms (2)

Radiofrequency group

EXPERIMENTAL

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.

Other: Radiofrequency

Control (Sham Radiofrequency) group

SHAM COMPARATOR

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

Other: Radiofrequency

Interventions

RadiofrequencyOTHER

See previous page

Control (Sham Radiofrequency) groupRadiofrequency group

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Montreal General Hospital

Montreal, Quebec, H3A 1A1, Canada

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 20, 2018

First Posted

November 29, 2018

Study Start

December 1, 2017

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

November 29, 2018

Record last verified: 2018-08

Locations

CA(1)