Postoperative PainNCT03893292
Preop Cooled Radiofrequency Ablation for Total Knee Replacement
An observational study of Postoperative Pain and Knee Osteoarthritis, run by Hospital for Special Surgery, New York at 1 site in United States.
Trial summary
Total knee replacement surgery is commonly performed for patients suffering from severe knee osteoarthritis. However, 20% of patients continue to experience pain after surgery. There is currently no standardized pain management protocol for pain after total knee replacement. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Postoperative Pain, Knee Osteoarthritis
- What is being tested?
- Total knee replacement and COOLIEF
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jan 2019to 30 Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients undergoing unilateral primary total knee replacement for the treatment of knee osteoarthritis
Who may be able to join
- Patients undergoing unilateral primary total knee replacement for osteoarthritis
- Pain >6 (on a scale of 0-10)
- Body mass index: 21-35 kg/m2
Who cannot join
- Age <65 years
- Patients who are wheelchair bound
- History of inflammatory arthritis or rheumatic disease
- Body mass index <21 or >35 kg/m2
- Chronic opioid use
- Pregnant women
- Non-English speaking
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital for Special Surgery
New York, New York, 10021
About this study
Official title: A Pilot Study on the Utility of Cooled Radiofrequency Ablation in Patients Prior to Total Knee Arthroplasty
Total knee replacement surgery is commonly performed for patients suffering from severe knee osteoarthritis. However, 20% of patients continue to experience pain after surgery. There is currently no standardized pain management protocol for pain after total knee replacement. Cooled radiofrequency ablation has been used successfully to alleviate spin-related pain and has recently been approved by the FDA to treat chronic knee arthritic pain. This pilot study aims to collect preliminary data on the use of cooled radiofrequency ablation in patients undergoing total knee replacement.
Read the detailed description
The number of patients who undergo total knee replacement is rising significantly. However, many of these patients are dissatisfied with the results, because they continue to experience pain postoperatively. This pain can be debilitating and can also be associated with decreased quality of life. Given the increasing number of patients undergoing total knee replacement and a dissatisfaction rate of 8-44%, improvements must be made in pain management protocols to help decrease pain in the immediate postoperative period following total knee replacement. Cooled radiofrequency ablation is a procedure that uses water-cooled technology to denervate the sensory nerves. It is widely used in the spine and is increasingly being used in the knee to treat osteoarthritis. Existing studies have shown that it can significantly reduce pain in patients with chronic osteoarthritis. In terms of its potential benefit as a preoperative measure to minimize postoperative pain, the literature is sparse. Results from this study will be used to generate hypotheses and power for future studies.
- Conditions
- Postoperative Pain, Knee Osteoarthritis
- Being tested
- Total knee replacement, COOLIEF
- Medical subject headings
- Pain, Postoperative, Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total knee replacementProcedure or surgery
Patients will undergo total knee replacement surgery.
COOLIEFDevice
The superior lateral genicular nerve, superior medial genicular nerve, and inferior medial geniculate nerve will be ablated.
| Study group | Role | What they receive |
|---|---|---|
| Preoperative cooled radiofrequency ablation | Patients who undergo cooled radiofrequency ablation within 4-8 weeks of their scheduled total knee replacement. Receives: Procedure: Total knee replacement; Device: COOLIEF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
Pain will be assessing on a 0-10 scale, where 0=no pain and 10=most pain.
Measured: Up to 1 year post-total knee replacement
Secondary outcomes (2)
Knee Disability
Knee disability will be assessed using the Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS JR). The score ranges from 0-100, where 0=total knee disability and 10=perfect health.
Measured: Up to 1 year post-total knee replacement
Function assessed using the PROMIS-physical function computer adaptive test
Function will be assessed using the PROMIS-physical function computer adaptive test. A higher score indicates higher function.
Measured: Up to 1 year post-total knee replacement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2019
- Study start24 Jan 2019
- Primary completion30 Oct 2020
- Study completion30 Oct 2020
Why it stopped: Lack of participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital for Special Surgery, New York
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jonathan Kirschner, MD, Principal investigator, Hospital for Special Surgery, New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03893292
- Sponsor's protocol ID
- 2018-1149
- Status last verified
- Nov 2020
- First submitted
- 26 Mar 2019
- Last updated
- 13 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study on the Utility of Cooled Radiofrequency Ablation in Patients Prior to Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT03893292
- Acronym / sponsor ID
- 2018-1149
- Conditions
- Postoperative Pain, Knee Osteoarthritis
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Lack of participants
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hospital for Special Surgery, New YorkUniversity, hospital or other
- Study start
- 24 Jan 2019 (actual)
- Primary completion
- 30 Oct 2020 (actual)
- Study completion
- 30 Oct 2020 (actual)
- First posted
- 28 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Total knee replacement surgery is commonly performed for patients suffering from severe knee osteoarthritis. However, 20% of patients continue to experience pain after surgery. There is currently no standardized pain management protocol for pain after total knee replacement. Cooled radiofrequency ablation has been used successfully to alleviate spin-related pain and has recently been approved by the FDA to treat chronic knee arthritic pain. This pilot study aims to collect preliminary data on the use of cooled radiofrequency ablation in patients undergoing total knee replacement.
Detailed description
The number of patients who undergo total knee replacement is rising significantly. However, many of these patients are dissatisfied with the results, because they continue to experience pain postoperatively. This pain can be debilitating and can also be associated with decreased quality of life. Given the increasing number of patients undergoing total knee replacement and a dissatisfaction rate of 8-44%, improvements must be made in pain management protocols to help decrease pain in the immediate postoperative period following total knee replacement. Cooled radiofrequency ablation is a procedure that uses water-cooled technology to denervate the sensory nerves. It is widely used in the spine and is increasingly being used in the knee to treat osteoarthritis. Existing studies have shown that it can significantly reduce pain in patients with chronic osteoarthritis. In terms of its potential benefit as a preoperative measure to minimize postoperative pain, the literature is sparse. Results from this study will be used to generate hypotheses and power for future studies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Preoperative cooled radiofrequency ablation | – | Procedure: Total knee replacement, Device: COOLIEFPatients who undergo cooled radiofrequency ablation within 4-8 weeks of their scheduled total knee replacement. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients undergoing unilateral primary total knee replacement for the treatment of knee osteoarthritis
Key inclusion criteria (3 listed)
- Patients undergoing unilateral primary total knee replacement for osteoarthritis
- Pain >6 (on a scale of 0-10)
- Body mass index: 21-35 kg/m2
Key exclusion criteria (7 listed)
- Age <65 years
- Patients who are wheelchair bound
- History of inflammatory arthritis or rheumatic disease
- Body mass index <21 or >35 kg/m2
- Chronic opioid use
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 |
|---|---|---|
| Total knee replacementPatients will undergo total knee replacement surgery. | Procedure or surgery | Preoperative cooled radiofrequency ablation |
| COOLIEFThe superior lateral genicular nerve, superior medial genicular nerve, and inferior medial geniculate nerve will be ablated. | Device | Preoperative cooled radiofrequency ablation |
Primary outcome
Pain
Time frame: Up to 1 year post-total knee replacement
Pain will be assessing on a 0-10 scale, where 0=no pain and 10=most pain.
2 secondary outcomes
Knee Disability
Time frame: Up to 1 year post-total knee replacement
Function assessed using the PROMIS-physical function computer adaptive test
Time frame: Up to 1 year post-total knee replacement
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2020.
- 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.
Jonathan Kirschner, MD principal investigator
Hospital for Special Surgery, New York
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Pain and Knee Osteoarthritis, run by Hospital for Special Surgery, New York 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 3 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: withdrawn, as of the sponsor's last update on 13 Nov 2020. 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. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Pain (time frame: Up to 1 year post-total knee replacement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Nov 2020; AzTrials last refreshed its copy on 31 Oct 2026.