Arthroplasty, Replacement, KneeNCT02746874
Does Radiofrequency Ablation of the Articular Nerves of the Knee Prior to Total Knee Replacement Improve Pain Outcomes
A study testing Radiofrequency Ablation (RFA) and Simulated Radiofrequency Ablation (RFA) in people with Arthroplasty, Replacement, Knee, run by Northwestern University at 1 site in United States.
Trial summary
More than 300,000 total knee joint replacement surgeries are performed per year in the United States and safe, effective management of post-operative pain in these patients, often elderly, deconditioned, obese, or with co-morbid diseases like sleep apnea, can be challenging and often require a multidisciplinary… Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Arthroplasty, Replacement, Knee
- What is being tested?
- Radiofrequency Ablation (RFA) and Simulated Radiofrequency Ablation (RFA)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2016to 31 Dec 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- osteoarthritis of the knee scheduled to undergo their first unilateral knee joint replacement
- willingness to undergo fluoroscopy-guided C-RFA or sham treatment
Who cannot join
- pregnancy,
- severe cardiac/pulmonary compromise,
- acute illness/infection,
- coagulopathy
- bleeding disorder,
- allergic reactions,
- contraindications to a local anesthetic
Trial locations and contacts
1 site in 1 country.
United States1 site
Anesthesiology Pain Medicine Center
Chicago, Illinois, 60611
About this study
Official title: Does Radiofrequency Ablation of the Articular Nerves of the Knee Prior to Total Knee Replacement Improve Pain Outcomes? A Prospective Randomized Sham-Control Trial With 6 Month Follow Up
More than 300,000 total knee joint replacement surgeries are performed per year in the United States and safe, effective management of post-operative pain in these patients, often elderly, deconditioned, obese, or with co-morbid diseases like sleep apnea, can be challenging and often require a multidisciplinary, multimodal approach. Opiates have been a mainstay of treatment in the post-operative period with varying degrees of success and complications. Inadequately controlled postoperative pain is not uncommon. Poorly controlled pain inhibits early mobilization and hinders post-operative physical therapy.
A new paradigm for treating post-operative pain following total knee replacement may be the use of cooled radiofrequency ablation (C-RFA) of the articular sensory nerve supply of the knee capsule prior to surgery, to desensitize the knee by blocking sensory afferents to the anterior capsule and thereby decrease post-operative pain. There are several publications that have demonstrated the use of RFA in patients with chronic knee pain from osteoarthritis however the use of RFA in the preoperative management of pain in patients undergoing total knee joint replacement has not been investigated.
The aim of this study is to determine if patients undergoing unilateral total knee replacement obtain any post-operative pain relieving benefits from C-RFA of the articular sensory nerve supply when performed prior to surgery, as compared to sham controls who receive only local anesthetic injections of these same nerves without the benefit of ablation treatment.
- Conditions
- Arthroplasty, Replacement, Knee
- Being tested
- Radiofrequency Ablation (RFA), Simulated Radiofrequency Ablation (RFA)
- Keywords
- Total Knee Replacement, Replacement of the knee joint,
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency Ablation (RFA)Procedure or surgery
The radiofrequency generator which will be turned on but will not be in the patient's view. The skin overlying the target sites identified with image guidance will be numb using lidocaine 1%. A needle will be placed through the skin to be optimally positioned according to the three targets. Sensory and motor testing will be performed to confirm appropriate placement. Lidocaine 2% 1-2cc will be injected prior to lesioning.
Simulated Radiofrequency Ablation (RFA)Procedure or surgery
The radiofrequency generator which will be turned on but will not be in the patient's view. The skin overlying the target sites identified with image guidance will be numb using lidocaine 1%. A needle will be placed through the skin to be optimally positioned according to the three targets. Sensory and motor testing will be performed to confirm appropriate placement. Lidocaine 2% 1-2cc will be injected. A simulate sham lesion will be performed at each target site.
| Study group | Role | What they receive |
|---|---|---|
| Active Group | Active comparator | Radiofrequency ablation procedure of the three articular branches of the knee joint. The targets will be thermally lesioned for 2 minutes 30 seconds thereby causing neurolysis. Receives: Procedure: Radiofrequency Ablation (RFA) |
| Placebo Group | Sham comparator | Simulated Radiofrequency Ablation procedure of the three articular branches of the knee joint.The targets will be not be thermally lesioned for 2 minutes 30 seconds therefore not causing neurolysis. Receives: Procedure: Simulated Radiofrequency Ablation (RFA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid Consumption After Surgery
Pain medication will be calculated into oral morphine equivalents (ME) for the first 48 hours after surgery. Morphine equivalents determine a patient's cumulative intake of any drugs in the opioid class.
Measured: 48 hours
Secondary outcomes (6)
Oral Morphine Equivalent Milligrams at Baseline.
The total morphine equivalent (milligrams) reported by the subject at baseline.
Measured: Pre operative
Oral Morphine Equivalents at Baseline Compared to 48 Hours Post-operative.
Total oral morphine equivalents at baseline compared to oral morphine equivalents at 48 hours post-operative.
Measured: 48 hours
Medication Quantification Scale III (MQSIII) Score 48 Hours Post-operative.
Medication Quantification Scale III (MQSIII) is a method of quantifying different pain drug regimens by evaluating the use of 22 distinct drug classes (e.g., nonsteroidal anti-inflammatory drugs [NSAIDs], antidepressants, benzodiazepines, opiates). A single value is calculated based on a patient's pain medication profile, taking into account dosages, and the types of pain medications prescribed. The score is calculated for a given pharmacologic class by taking its detriment weight, as determined by the physician, multiplied by a score given for dosage. The scores for each pharmacologic class prescribed to a patient are then summed to determine the overall score of a given pain medication regimen. The scale ranges from (0 low (good) 500 high (poor).
Measured: 48 hours
Number of Stairs Climbed on Post-operative Day 2.
Number of stairs climbed on post-operative day 2 prior to discharge from the hospital.
Measured: Post operative day 2
Distance Walked on Post-operative Day 2.
Distance in feet walked on post-operative day 2 prior to discharge from the hospital.
Measured: Post operative day 2
Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score 6 Months Post Operative
Western Ontario and McMaster Universities Arthritis Index (WOMAC) score 6 months post operative. The WOMAC score is a survey comprised of 24 items divided into three subscales: Pain (5 items), stiffness (2 items), and physical function (17 items). Subjects are asked a range of questions about their ability to carry out daily activities such as using the stairs, rising from sitting, lying in bed and conducting light or heavy domestic duties. Items are scored on a scale of 0-4 (lower scores indicate lower levels of symptoms or physical disability). Values are summed up for a combined WOMAC score of 0 (low) to 96 (high) Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitation.
Measured: 6 months post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2016 (estimated)
- Study start1 Dec 2016
- Primary completion30 Jun 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Arthroplasty, Replacement, KneeStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Walega, Northwestern University
- Investigators
- David Walega, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02746874
- Sponsor's protocol ID
- STU00200439
- Status last verified
- Jan 2021
- First submitted
- 18 Apr 2016
- Last updated
- 2 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Walega D, McCormick Z, Manning D, Avram M. Radiofrequency ablation of genicular nerves prior to total knee replacement has no effect on postoperative pain outcomes: a prospective randomized sham-controlled trial with 6-month follow-up. Reg Anesth Pain Med. 2019 Apr 25:rapm-2018-100094. doi: 10.1136/rapm-2018-100094. Online ahead of print.
PubMed 31023931
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Radiofrequency Ablation of the Articular Nerves of the Knee Prior to Total Knee Replacement Improve Pain Outcomes? A Prospective Randomized Sham-Control Trial With 6 Month Follow Up
- ClinicalTrials.gov ID
- NCT02746874
- Acronym / sponsor ID
- STU00200439
- Conditions
- Arthroplasty, Replacement, Knee
- Keywords
- Total Knee Replacement, Replacement of the knee joint,
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 21 Apr 2016 (estimated)
- Results
- Posted 2 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
More than 300,000 total knee joint replacement surgeries are performed per year in the United States and safe, effective management of post-operative pain in these patients, often elderly, deconditioned, obese, or with co-morbid diseases like sleep apnea, can be challenging and often require a multidisciplinary, multimodal approach. Opiates have been a mainstay of treatment in the post-operative period with varying degrees of success and complications. Inadequately controlled postoperative pain is not uncommon. Poorly controlled pain inhibits early mobilization and hinders post-operative physical therapy.
A new paradigm for treating post-operative pain following total knee replacement may be the use of cooled radiofrequency ablation (C-RFA) of the articular sensory nerve supply of the knee capsule prior to surgery, to desensitize the knee by blocking sensory afferents to the anterior capsule and thereby decrease post-operative pain. There are several publications that have demonstrated the use of RFA in patients with chronic knee pain from osteoarthritis however the use of RFA in the preoperative management of pain in patients undergoing total knee joint replacement has not been investigated.
The aim of this study is to determine if patients undergoing unilateral total knee replacement obtain any post-operative pain relieving benefits from C-RFA of the articular sensory nerve supply when performed prior to surgery, as compared to sham controls who receive only local anesthetic injections of these same nerves without the benefit of ablation treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Group | Active comparator | Procedure: Radiofrequency Ablation (RFA)Radiofrequency ablation procedure of the three articular branches of the knee joint. The targets will be thermally lesioned for 2 minutes 30 seconds thereby causing neurolysis. |
| Placebo Group | Sham comparator | Procedure: Simulated Radiofrequency Ablation (RFA)Simulated Radiofrequency Ablation procedure of the three articular branches of the knee joint.The targets will be not be thermally lesioned for 2 minutes 30 seconds therefore not causing neurolysis. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- osteoarthritis of the knee scheduled to undergo their first unilateral knee joint replacement
- willingness to undergo fluoroscopy-guided C-RFA or sham treatment
Key exclusion criteria (7 listed)
- pregnancy,
- severe cardiac/pulmonary compromise,
- acute illness/infection,
- coagulopathy
- bleeding disorder,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiofrequency Ablation (RFA)The radiofrequency generator which will be turned on but will not be in the patient's view. The skin overlying the target sites identified with image guidance will be numb using lidocaine 1%. A needle will be placed through the skin to be optimally positioned according to the three targets. Sensory and motor testing will be performed to confirm appropriate placement. Lidocaine 2% 1-2cc will be injected prior to lesioning. | Procedure or surgery | Active Group |
| Simulated Radiofrequency Ablation (RFA)The radiofrequency generator which will be turned on but will not be in the patient's view. The skin overlying the target sites identified with image guidance will be numb using lidocaine 1%. A needle will be placed through the skin to be optimally positioned according to the three targets. Sensory and motor testing will be performed to confirm appropriate placement. Lidocaine 2% 1-2cc will be injected. A simulate sham lesion will be performed at each target site. | Procedure or surgery | Placebo Group |
Primary outcome
Opioid Consumption After Surgery
Time frame: 48 hours
Pain medication will be calculated into oral morphine equivalents (ME) for the first 48 hours after surgery. Morphine equivalents determine a patient's cumulative intake of any drugs in the opioid class.
6 secondary outcomes
Oral Morphine Equivalent Milligrams at Baseline.
Time frame: Pre operative
Oral Morphine Equivalents at Baseline Compared to 48 Hours Post-operative.
Time frame: 48 hours
Medication Quantification Scale III (MQSIII) Score 48 Hours Post-operative.
Time frame: 48 hours
Number of Stairs Climbed on Post-operative Day 2.
Time frame: Post operative day 2
Distance Walked on Post-operative Day 2.
Time frame: Post operative day 2
Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score 6 Months Post Operative
Time frame: 6 months post operative
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31023931Walega D, McCormick Z, Manning D, Avram M. Radiofrequency ablation of genicular nerves prior to total knee replacement has no effect on postoperative pain outcomes: a prospective randomized sham-controlled trial with 6-month follow-up. Reg Anesth Pain Med. 2019 Apr 25:rapm-2018-100094. doi: 10.1136/rapm-2018-100094. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Walega, MD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiofrequency Ablation (RFA) and Simulated Radiofrequency Ablation (RFA) in people with Arthroplasty, Replacement, Knee, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opioid Consumption After Surgery (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02746874, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2021.