Osteoarthritis of the KneeNCT02343003
Nerve Ablation by Cooled Radiofrequency Compared to Corticosteroid Injection for Management of Knee Pain
A study testing Cooled Radiofrequency and Corticosteroid injection in people with Osteoarthritis of the Knee, run by Halyard Health at 11 sites in United States.
Trial summary
This study is designed to: Determine the effectiveness (primarily measured by pain relief) of Coolief when used to create radiofrequency lesions of the genicular nerves compared to pain relief following corticosteroid injection; and Confirm the safety of Coolief when used to perform radiofrequency lesions of the… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Osteoarthritis of the Knee
- What is being tested?
- Cooled Radiofrequency and Corticosteroid injection
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 151 participants
- Where
- 11 sitesUnited States
- Study dates
- Jan 2015to 16 Mar 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 21 years
- Able to understand the informed consent form and provide written informed consent and able to complete outcome measures
- History of chronic knee pain for longer than 6 months unresponsive to conservative treatments (PT, oral analgesics, intra-articular injections with steroids and/or viscosupplementation)
- Positive response (defined as a decrease in numeric pain scores of at least 50%) to a geniculate nerve block of the index knee
- Pain on NRS ≥ 6 on a 10 point scale for the index knee
- Radiologic confirmation of osteoarthritis (x-ray/MRI/CT) of OA grade of 2 (mild), 3 (moderate) or 4 (severe) noted within 12 months for the index knee
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- Oxford Knee Score group at Baseline of ≤ 35 indicating moderate to severe OA in the index knee
- If the patient is taking an opioid or other morphine equivalent medication, the dose must be considered clinically stable (defined as <10% change in dosage for ≥ 2 months prior to the screening visit).
- Analgesics including membrane stabilizers such as Neurontin and antidepressants for pain such as Cymbalta must be clinically stable (defined as stable dosage for ≥ 6 weeks prior to the screening visit) and shall not change during the course of the study without approval of investigator. Agree to see one pain doctor (study investigator) for knee pain during the study period
- Index knee pathology that is consistent with generally accepted indications for total knee arthroplasty.
- Willing to delay any surgical intervention for the index knee for 12 months.
- Willingness to provide informed consent and to comply with the requirements of this protocol for the full duration.
Who cannot join
- Pseudo arthritis, rheumatoid arthritis or other systemic inflammatory arthritis condition that could cause knee pain.
- Previous or pending lower limb amputation.
- Intra-articular steroid, platelet rich plasma (PRP) or hyaluronic acid injections in the index knee within 90 days from the screening visit.
- An intra-articular corticosteroid injection is not indicated as an appropriate treatment option.
- Prior radiofrequency of the genicular nerves of the index knee.
- Prior partial, resurfacing, or total knee arthroplasty in index knee.
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- Clinically significant ligamentous laxity of the index knee.
- Evidence of structural abnormality other than osteoarthritis of knee, hip or back that materially affects gait or function of the knee or is the underlying cause of the knee pain.
- BMI > 40.
- Extremely thin patients and those with minimal subcutaneous tissue thickness that would not accommodate a lesion of up to 14 mm in diameter to limit the risk of skin burns.
- Pending or active compensation claim, litigation or disability remuneration (secondary gain) related to knee.
- Pregnant or intent of becoming pregnant during the study period.
- Chronic pain associated with significant psychosocial dysfunction.
- Beck's Depression Index score of > 22 (indicates clinically depressed state).
- Allergies to any of the medications to be used during the procedure.
- Systemic or localized infection at needle entry sites (subject may be considered for inclusion once infection is resolved).
- History of uncontrolled coagulopathy, ongoing coagulation treatment or unexplained or uncontrollable bleeding that is uncorrectable.
- Identifiable anatomical variability that would materially alter the procedure as described in the protocol.
- Within the preceding 2 years, subject has suffered from active narcotic addiction, substance or alcohol abuse.
- Current prescribed opioid medications equivalent to greater than 60 morphine equivalent daily opioid dose.
- Uncontrolled immunosuppression (e.g. AIDS, cancer, diabetes, etc.)
- Subject currently implanted with pacemaker or defibrillator.
- Participating in another clinical trial/investigation within 30 days prior to signing informed consent.
- Subject unwilling or unable to comply with follow up schedule or protocol requirements.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Rush University Medical Center
Chicago, Illinois, 60612
Advanced Pain Management
Greenfield, Wisconsin, 53221
Piedmont Comprehensive Pain Management
Greenville, South Carolina, 29622
MAPS Applied Research Center, Inc.
Maple Grove, Minnesota, 55369
Ainsworth Institute of Pain Management
New York, New York, 10022
Drexel University
Philadelphia, Pennsylvania, 19104
Valley Anesthesiology Consultants - Estrella
Phoenix, Arizona, 85037
Virginia iSpine Physicians
Richmond, Virginia, 23235
Orthopedic Pain Specialists
Santa Monica, California, 90403
Valley Anesthesiology Consultants/Valley Pain Consultants
Scottsdale, Arizona, 85254
Center for Clinical Research
Winston-Salem, North Carolina, 27103
About this study
Official title: A Prospective, Multi-Center, RCT Evaluating the Safety and Effectiveness of Coolief™ Cooled Radiofrequency Probe to Create Lesions of the Genicular Nerves and Comparing Corticosteroid Injection in the Management of Knee Pain
This study is designed to:
- Determine the effectiveness (primarily measured by pain relief) of Coolief when used to create radiofrequency lesions of the genicular nerves compared to pain relief following corticosteroid injection; and
- Confirm the safety of Coolief when used to perform radiofrequency lesions of the genicular nerves in subjects to manage knee pain compared to safety of corticosteroid injection
Read the detailed description
This is a prospective, randomized, multicenter comparison study examining the outcomes of subjects having knee pain undergoing a procedure to create a radiofrequency lesion of the genicular nerves with the Coolief system compared to subjects receiving corticosteroid injection. A total of approximately 144 subjects will be enrolled into this study with subjects undergoing either radiofrequency neurotomy or corticosteroid injection in a 1:1 randomization scheme. Follow up will be conducted for a total of 12 months post Coolief procedure with the primary endpoint being completed at month 6. Subjects randomized to the comparison (corticosteroid) group will have the option to cross over to the neurotomy group after completing the 6 month endpoint assessment. They would then be followed for an additional 6 months. Pain, overall outcome, quality of life, pain medication use, and adverse events will be compared between the two treatment groups in order to determine success.
Primary Effectiveness Endpoint:
The proportion of subjects whose knee pain is reduced by ≥ 50% based on the NRS scale at 6 Months.
Primary Safety Endpoint:
The proportion of subjects experiencing adverse events through final follow up.
Secondary Effectiveness Endpoints:
- The proportion of subjects whose knee pain is reduced from baseline by ≥ 50% based on the Numeric Rating Scale (NRS) at 12 months.
- Improvement in global outcome from baseline as measured by the Oxford Knee Score at 6 months and 12 months.
Tertiary Effectiveness Endpoint:
Subject satisfaction as measured by the Global Perceived Effect Score at 6 months and 12 months.
Quaternary Effectiveness Endpoint:
Reduction in pain medication usage from baseline as measured by subject self-reported average daily dosage.
In addition, exploratory analyses of health economic indicators may be performed.
Subjects will participate in the study for up to 13 months (2 week roll-in period + treatment visit + 12 month follow up), except for subjects who participate in the optional crossover group. These crossover subjects will be on study for up to 15 months (2 week roll-in + treatment + 6 month follow-up and crossover + 6 month follow up). Enrollment is anticipated to take approximately 6-8 months.
- Conditions
- Osteoarthritis of the Knee
- Being tested
- Cooled Radiofrequency, Corticosteroid injection
- Keywords
- cooled radiofrequency ablation, knee pain, osteoarthritis, pain management
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cooled RadiofrequencyDevice
Also called Coolief
Delivery of energy to ablate sensory nerves via cooled radiofrequency probe
Corticosteroid injectionDrug
Delivery of corticosteroid into knee by injection with needle to reduce knee pain
| Study group | Role | What they receive |
|---|---|---|
| Cooled radiofrequency | Experimental | Cooled radiofrequency energy will be delivered to study subjects' knees to ablate culprit sensory nerves and reduce knee pain Receives: Device: Cooled Radiofrequency |
| Corticosteroid injection | Active comparator | Corticosteroid injections will be administered to study subjects' knees to reduce knee pain Receives: Drug: Corticosteroid injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Rating Scale (NRS)
The number of subjects whose knee pain is reduced by ≥ 50% based on the Numeric Rating Scale (NRS). The NRS is an 11-point scale (0 points to 10 points), where 0 points equals "no pain" and 10 points equals the "worst pain".
Measured: 6 months
Safety: Number of Subjects Experiencing Adverse Events Through Final Follow up.
Safety Endpoint: Number of subjects experiencing adverse events through final follow up.
Measured: 6 months and 12 months
Secondary outcomes (2)
Numeric Rating Scale
The number of subjects whose knee pain is reduced from baseline by ≥ 50% based on the Numeric Rating Scale (NRS) at 12 months. The NRS is an 11-point scale (0 points to 10 points), where 0 points equals "no pain" and 10 points equals the "worst pain".
Measured: 12 months
Oxford Knee Score
Improvement in global outcome from baseline as measured by the Oxford Knee Score at 6 months and 12 months. The Oxford Knee Score is determined by a 12-question survey that measures knee function, and is scored on a scale that ranges from 0 - 48 points, with scores of 0 - 19 = "severe arthritis", 20 - 29 = "moderate to severe arthritis", 30 - 39 = "mild to moderate arthritis", and 40 - 48 = "satisfactory joint function".
Measured: 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2015 (estimated)
- Study startJan 2015
- Primary completionAug 2016
- Study completion16 Mar 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 (2)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis of the KneeStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Halyard Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David T Curd, MS, Study director, Halyard Health, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02343003
- Sponsor's protocol ID
- 105-14-0001
- Status last verified
- Feb 2017
- First submitted
- 15 Jan 2015
- Last updated
- 13 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Davis T, Loudermilk E, DePalma M, Hunter C, Lindley DA, Patel N, Choi D, Soloman M, Gupta A, Desai M, Cook E, Kapural L. Twelve-month analgesia and rescue, by cooled radiofrequency ablation treatment of osteoarthritic knee pain: results from a prospective, multicenter, randomized, cross-over trial. Reg Anesth Pain Med. 2019 Feb 16:rapm-2018-100051. doi: 10.1136/rapm-2018-100051. Online ahead of print.
PubMed 30772821Davis T, Loudermilk E, DePalma M, Hunter C, Lindley D, Patel N, Choi D, Soloman M, Gupta A, Desai M, Buvanendran A, Kapural L. Prospective, Multicenter, Randomized, Crossover Clinical Trial Comparing the Safety and Effectiveness of Cooled Radiofrequency Ablation With Corticosteroid Injection in the Management of Knee Pain From Osteoarthritis. Reg Anesth Pain Med. 2018 Jan;43(1):84-91. doi: 10.1097/AAP.0000000000000690.
PubMed 29095245
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-Center, RCT Evaluating the Safety and Effectiveness of Coolief™ Cooled Radiofrequency Probe to Create Lesions of the Genicular Nerves and Comparing Corticosteroid Injection in the Management of Knee Pain
- ClinicalTrials.gov ID
- NCT02343003
- Acronym / sponsor ID
- 105-14-0001
- Conditions
- Osteoarthritis of the Knee
- Keywords
- cooled radiofrequency ablation, knee pain, osteoarthritis, pain management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Halyard HealthIndustry (pharma, biotech, devices)
- Study start
- Jan 2015 (actual)
- Primary completion
- Aug 2016 (actual)
- Study completion
- 16 Mar 2017 (actual)
- First posted
- 21 Jan 2015 (estimated)
- Results
- Posted 9 Oct 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to:
- Determine the effectiveness (primarily measured by pain relief) of Coolief when used to create radiofrequency lesions of the genicular nerves compared to pain relief following corticosteroid injection; and
- Confirm the safety of Coolief when used to perform radiofrequency lesions of the genicular nerves in subjects to manage knee pain compared to safety of corticosteroid injection
Detailed description
This is a prospective, randomized, multicenter comparison study examining the outcomes of subjects having knee pain undergoing a procedure to create a radiofrequency lesion of the genicular nerves with the Coolief system compared to subjects receiving corticosteroid injection. A total of approximately 144 subjects will be enrolled into this study with subjects undergoing either radiofrequency neurotomy or corticosteroid injection in a 1:1 randomization scheme. Follow up will be conducted for a total of 12 months post Coolief procedure with the primary endpoint being completed at month 6. Subjects randomized to the comparison (corticosteroid) group will have the option to cross over to the neurotomy group after completing the 6 month endpoint assessment. They would then be followed for an additional 6 months. Pain, overall outcome, quality of life, pain medication use, and adverse events will be compared between the two treatment groups in order to determine success.
Primary Effectiveness Endpoint:
The proportion of subjects whose knee pain is reduced by ≥ 50% based on the NRS scale at 6 Months.
Primary Safety Endpoint:
The proportion of subjects experiencing adverse events through final follow up.
Secondary Effectiveness Endpoints:
- The proportion of subjects whose knee pain is reduced from baseline by ≥ 50% based on the Numeric Rating Scale (NRS) at 12 months.
- Improvement in global outcome from baseline as measured by the Oxford Knee Score at 6 months and 12 months.
Tertiary Effectiveness Endpoint:
Subject satisfaction as measured by the Global Perceived Effect Score at 6 months and 12 months.
Quaternary Effectiveness Endpoint:
Reduction in pain medication usage from baseline as measured by subject self-reported average daily dosage.
In addition, exploratory analyses of health economic indicators may be performed.
Subjects will participate in the study for up to 13 months (2 week roll-in period + treatment visit + 12 month follow up), except for subjects who participate in the optional crossover group. These crossover subjects will be on study for up to 15 months (2 week roll-in + treatment + 6 month follow-up and crossover + 6 month follow up). Enrollment is anticipated to take approximately 6-8 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cooled radiofrequency | Experimental | Device: Cooled RadiofrequencyCooled radiofrequency energy will be delivered to study subjects' knees to ablate culprit sensory nerves and reduce knee pain |
| Corticosteroid injection | Active comparator | Drug: Corticosteroid injectionCorticosteroid injections will be administered to study subjects' knees to reduce knee pain |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age ≥ 21 years
- Able to understand the informed consent form and provide written informed consent and able to complete outcome measures
- History of chronic knee pain for longer than 6 months unresponsive to conservative treatments (PT, oral analgesics, intra-articular injections with steroids and/or viscosupplementation)
- Positive response (defined as a decrease in numeric pain scores of at least 50%) to a geniculate nerve block of the index knee
- Pain on NRS ≥ 6 on a 10 point scale for the index knee
Key exclusion criteria (24 listed)
- Pseudo arthritis, rheumatoid arthritis or other systemic inflammatory arthritis condition that could cause knee pain.
- Previous or pending lower limb amputation.
- Intra-articular steroid, platelet rich plasma (PRP) or hyaluronic acid injections in the index knee within 90 days from the screening visit.
- An intra-articular corticosteroid injection is not indicated as an appropriate treatment option.
- Prior radiofrequency of the genicular nerves of the index knee.
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 |
|---|---|---|
| Cooled RadiofrequencyAlso: CooliefDelivery of energy to ablate sensory nerves via cooled radiofrequency probe | Device | Cooled radiofrequency |
| Corticosteroid injectionDelivery of corticosteroid into knee by injection with needle to reduce knee pain | Drug | Corticosteroid injection |
Primary outcome
Numeric Rating Scale (NRS)
Time frame: 6 months
The number of subjects whose knee pain is reduced by ≥ 50% based on the Numeric Rating Scale (NRS). The NRS is an 11-point scale (0 points to 10 points), where 0 points equals "no pain" and 10 points equals the "worst pain".
Safety: Number of Subjects Experiencing Adverse Events Through Final Follow up.
Time frame: 6 months and 12 months
Safety Endpoint: Number of subjects experiencing adverse events through final follow up.
2 secondary outcomes
Numeric Rating Scale
Time frame: 12 months
Oxford Knee Score
Time frame: 6 months and 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30772821Davis T, Loudermilk E, DePalma M, Hunter C, Lindley DA, Patel N, Choi D, Soloman M, Gupta A, Desai M, Cook E, Kapural L. Twelve-month analgesia and rescue, by cooled radiofrequency ablation treatment of osteoarthritic knee pain: results from a prospective, multicenter, randomized, cross-over trial. Reg Anesth Pain Med. 2019 Feb 16:rapm-2018-100051. doi: 10.1136/rapm-2018-100051. Online ahead of print.
- Derived from this study: PubMed 29095245Davis T, Loudermilk E, DePalma M, Hunter C, Lindley D, Patel N, Choi D, Soloman M, Gupta A, Desai M, Buvanendran A, Kapural L. Prospective, Multicenter, Randomized, Crossover Clinical Trial Comparing the Safety and Effectiveness of Cooled Radiofrequency Ablation With Corticosteroid Injection in the Management of Knee Pain From Osteoarthritis. Reg Anesth Pain Med. 2018 Jan;43(1):84-91. doi: 10.1097/AAP.0000000000000690.
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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 T Curd, MS study director
Halyard Health, Inc.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cooled Radiofrequency and Corticosteroid injection in people with Osteoarthritis of the Knee, run by Halyard Health at 11 sites 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 12 inclusion and 24 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 13 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites 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?
Yes. Results are posted in the registry (first posted 9 Oct 2017). 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?
Numeric Rating Scale (NRS) (time frame: 6 months). The study lists 2 primary outcomes in all. 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 NCT02343003, which also lists 2 linked publications.
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 May 2019.