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Trial registered on ANZCTR


Registration number
ACTRN12619000970145
Ethics application status
Approved
Date submitted
19/06/2019
Date registered
9/07/2019
Date last updated
21/08/2020
Date data sharing statement initially provided
9/07/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Novel Application of Cooled Radiofrequency Ablation for Pain Management after Total Knee Arthroplasty.
Scientific title
Novel Application of Cooled Radiofrequency Ablation for Pain Management after Total Knee Arthroplasty.
Secondary ID [1] 298486 0
Nil known
Universal Trial Number (UTN)
U1111-1235-2551
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis 313268 0
Condition category
Condition code
Musculoskeletal 311712 311712 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
TKR surgery will be carried out according to the investigating surgeon's standard protocol, described below. After the patient is anesthetised, the skin is cleaned with antiseptic solution and covered with sterile drapes. An incision is made down the middle of the knee of about 20cm in length. The knee joint is then visible and is cut and the patella is pushed to one side. The ends of the femur and tibia are cut using a bone saw. In some cases, the underside of the knee cap is removed. Using measuring devices, the new artificial knee joints (made of tantalum) are fitted into position and once the surgeon is satisfied with the positioning and movements of the knee, the tissue and skin are closed in layers with dissolvable sutures. These sutures do not need to be removed but the wound remains covered until healing is complete (around 10-14 days).
Prior to wound closure, the intervention will be administered which involves additional treatment with the Avanos Coolief Cooled Radiofrequency System. This involves the use of a radiofrequency generator that transmits a small current of radiofrequency energy through an insulated electrode that is placed within the tissues. Due to the friction of charged molecules, heating occurs and thermally deactivates the nerves responsible for sending pain signals to the brain. Radiofrequency energy is delivered through water-cooled electrodes, enabling more energy to be safely delivered to the target areas. The frequency of the system is 460khz which delivers an attenuated charge. The amplitude is a factor of impedance and ramp time to get to the 60degree set point. This lower intensity technique makes the risk of permanent or irreversible damage to the tissues very unlikely.
The application of the Coolief Cooled Radiofrequency System will add 5-10 minutes to the surgery time. Wounds will be closed in the standard fashion described above and standard post-operative care will be given. Patients are monitored closely in hospital for 3-5 days by nursing and medical staff before returning home. Patients are able to weight-bear, mobilise and commence rehabilitation immediately after surgery. In addition to standard hospital care, standard post-operative care is given by the investigating surgeon and his direct staff. This involves monitoring of pain levels and opioid intake daily for the first 3-5 days and then weekly until the 6 week mark. These are recorded in the patient’s hospital notes and confidential file which ensures close monitoring of the patients safety at all times.
The additional treatment will be delivered by the investigating surgeon; a highly skilled orthopaedic surgeon with over 30 years’ experience. All procedures will be conducted at the Mater Hospital Sydney in conjunction with North Sydney Orthopaedic and Sports Medicine Centre.
Intervention code [1] 314771 0
Treatment: Surgery
Intervention code [2] 314772 0
Treatment: Devices
Comparator / control treatment
Patient reported pain scores and opioid use of the intervention group in the first 6 weeks after surgery will be compared to those of an historic control group who received standard treatment under the care of the investigating surgeon at the Mater Hospital. The historic control group received standard post-operative care which involves initially daily (and subsequently weekly) follow-up by the investigating surgeon's support staff about pain levels and opioid intake until the 6 week post-operative mark. The data for the control group was collected between January and June 2019.
Control group
Historical

Outcomes
Primary outcome [1] 320456 0
Patient reported pain scores using the 0-10 Visual Analogue Scale for Pain (VAS Pain)
Timepoint [1] 320456 0
First 6 weeks after TKR surgery. The frequency of assessment will be daily post surgery for 3-5 days and then weekly until the 6 week post-operative mark.
Primary outcome [2] 320554 0
Opioid (morphine) use. A researcher will record the opioid intake from the previous 24 hours at the same time each day for the first 3-5 days after surgery. This will be documented in the patients medication chart. Morphine equivalent dosing will be calculated to determine the cumulative intake of opioid drug use for the previous 24 hours. Participants will also be asked to record their opioid intake in a pain medication table each week after surgery until the 6 week post-operative mark and this information will be recorded in the patients electronic file.
Timepoint [2] 320554 0
First 6 weeks after TKR surgery. The frequency of assessment will be daily post surgery for 3-5 days and then weekly until the 6 week post-operative mark.
Secondary outcome [1] 371649 0
Patient reported rehabilitation experience using standard subjective questionnaires.
Timepoint [1] 371649 0
Assessed at the 6 month and 12 month post-operative time points. All patients are sent a questionnaire via email or post and are asked to take 5-10 minutes to complete it themselves and send it back to the researchers. Patient's are asked to indicate on a 5 point scale (very satisfied, satisfied, neutral, dissatisfied, very dissatisfied) how they rate their rehabilitation experience and are asked if they would partake in the same rehabilitation protocol if they were to have surgery again. This data is entered into a database which allows the rehabilitation experience to be recorded objectively.
Secondary outcome [2] 372255 0
Patient reported function using standard subjective questionnaires.
Timepoint [2] 372255 0
Assessed at the 6 month and 12 month post-operative time points with the EQ-5D general health score, KOOS Jnr and Oxford Knee Score questionnaires. These are standardised questionnaires that are used widespread in the literature. They are not outcomes themselves but are tools used to assess overall patient reported function after TKR surgery. All patients are sent a questionnaire via email or post and are asked to take 5-10 minutes to complete it themselves and send it back to the researchers. Specific questionnaires all report on function and the data is entered into a database which allows the patient reported function to be recorded objectively.

Eligibility
Key inclusion criteria
- Elective primary unilateral TKR surgery performed by A/Prof Leo Pinczewski
- Age 50-80 years
- Male or female gender
- ASA grade of <4
- Willingness and ability to give informed consent and willingness to participate in and comply with the study
Minimum age
50 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- BMI >35
- Any contraindication to routine analgesic medication (paracetamol, meloxicam, opiates)
- Neuropathic pain pre-operatively
- Subjects taking steroid or opiate mediation pre-operatively
- Subjects with a coagulopathy or taking anti-coagulate medication pre-operatively
- History of neurological, sensory or motor deficit to the operated lower limb
- Cardiac pacemaker
- Failed previous spinal anaesthetic
- Previous major knee surgery (such as osteotomy)
- Bilateral TKR surgery

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Prospective pilot trial.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Statistical analysis will be performed using SPSS for Windows software. The mean daily pain scores and morphine equivalent dosing will be compared using t-tests between the group who received the Coolief treatment and historic control group. Statistical significance will be sat at a p<0.05.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
26/06/2019
Date of last participant enrolment
Anticipated
26/09/2019
Actual
19/02/2020
Date of last data collection
Anticipated
26/09/2020
Actual
1/04/2020
Sample size
Target
12
Accrual to date
Final
12
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 14012 0
Mater Sydney - North Sydney
Recruitment postcode(s) [1] 26797 0
2060 - North Sydney

Funding & Sponsors
Funding source category [1] 303031 0
Self funded/Unfunded
Name [1] 303031 0
A/Prof Leo Pinczewski
Country [1] 303031 0
Australia
Primary sponsor type
Other Collaborative groups
Name
North Sydney Orthopaedic and Sports Medicine Centre
Address
Suite 2, 3 Gilles St, Wollstonecraft, Sydney, NSW, 2065
Country
Australia
Secondary sponsor category [1] 303054 0
None
Name [1] 303054 0
Address [1] 303054 0
Country [1] 303054 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303584 0
St Vincent's Hospital Human Research Ethics Committee
Ethics committee address [1] 303584 0
St Vincent’s Hospital Sydney Research Office, St Vincent’s Health Network
Translational Research Centre, 97-105 Boundary Stree, Darlinghurst, NSW, 2010
Ethics committee country [1] 303584 0
Australia
Date submitted for ethics approval [1] 303584 0
01/04/2019
Approval date [1] 303584 0
30/05/2019
Ethics approval number [1] 303584 0

Summary
Brief summary
All patients booked for elective TKR surgery under the care of the investigating surgeon who meet the inclusion criteria will be invited to participate and informed consent will be obtained. Prior to surgery, all patients will complete standradr pre-operative testing and questionniares as is usual practice. A pre-operative pain score (average over 7 days prior to surgery) and pre-operative opioid use will be recorded in the patients electronic file.
TKR surgery will be carried out according to standard protocol. Prior to wound closure, additional treatment will be given with the Avanos Coolief Cooled Radiofrequency System. This involves the use of a radiofrequency generator that transmits a small current of radiofrequency energy through an insulated electrode that is placed within the tissues. Due to the friction of charged molecules, heating occurs and thermally deactivates the nerves responsible for sending pain signals to the brain. Radiofrequency energy is delivered through water-cooled electrodes, enabling more energy to be safely delivered to the target areas. This lower intensity technique makes the risk of permanent or irreversible damage to the tissues very unlikely.
The application of the Coolief Cooled Radiofrequency System will add 5-10 minutes to the surgery time. Wounds will be closed in the standard fashion and standard post-operative care will be given. Standard post-operative care involves initially daily (and subsequently weekly) follow-up about pain levels and opioid intake until the 6 week post-operative mark.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 94158 0
A/Prof Leo Pinczewski
Address 94158 0
North Sydney Orthopaedic and Sports Medicine Centre
Suite 2, 3 Gilles St, Wollstonecraft, Sydney, NSW, 2065
Country 94158 0
Australia
Phone 94158 0
+61 294375999
Fax 94158 0
+61 294379595
Email 94158 0
[email protected]
Contact person for public queries
Name 94159 0
Claire Monk
Address 94159 0
North Sydney Orthopaedic and Sports Medicine Centre
Suite 2, 3 Gilles St, Wollstonecraft, Sydney, NSW, 2065
Country 94159 0
Australia
Phone 94159 0
+61 294090530
Fax 94159 0
+61 294379595
Email 94159 0
[email protected]
Contact person for scientific queries
Name 94160 0
Claire Monk
Address 94160 0
North Sydney Orthopaedic and Sports Medicine Centre
Suite 2, 3 Gilles St, Wollstonecraft, Sydney, NSW, 2065
Country 94160 0
Australia
Phone 94160 0
+61 294090530
Fax 94160 0
+61 294379595
Email 94160 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.