Osteoarthritis of the KneeNCT03381248
Cooled Radiofrequency vs. Hyaluronic Acid to Manage Knee Pain
A study testing Cooled Radiofrequency, Hyaluronic Acid Injection and Crossover from Hyaluronic Acid Injection to Cooled Radiofrequency in people with Osteoarthritis of the Knee, run by Avanos Medical at 10 sites in United States.
Trial summary
This is a prospective, randomized, multicenter comparison study examining the outcomes of subjects with osteoarthritis and knee pain undergoing a procedure to create a radiofrequency lesion of the genicular nerves with the Cooled Radiofrequency Ablation (CRFA) system compared to subjects receiving Hyaluronic Acid… 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, Hyaluronic Acid Injection and Crossover from Hyaluronic Acid Injection to Cooled Radiofrequency
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 177 participants
- Where
- 10 sitesUnited States
- Study dates
- 7 Dec 2017to 20 Jul 2020
- 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
- Chronic knee pain for longer than 6 months that interferes with functional activities (for example, ambulation, prolonged standing, etc.)
- Continued pain in the target knee despite at least 3 months of conservative treatments, including activity modification, home exercise, protective weight bearing, and/or analgesics (for example, acetaminophen or non-steroidal anti-inflammatory drugs [NSAIDs])
- Positive response (defined as a decrease in numeric pain scores of at least 50%) to a single genicular nerve block of the index knee
- Pain on NRS ≥ 6 on an 11-point scale for the index knee
Show all 14Show fewer
- Radiologic confirmation of arthritis (x-ray/MRI/CT) of Osteoarthritis (OA) grade of 2 (mild), 3 (moderate) or 4 (severe) noted within 6 months for the index knee
- An intra-articular hyaluronic acid injection is indicated as an appropriate treatment option
- WOMAC Knee Score group at baseline of Score of ≥ 2 (0 to 4 scale) on WOMAC question 1 (Pain) and a mean score of ≥ 1.5 on all five questions of the WOMAC pain subscale.
- Analgesics including membrane stabilizers such as Neurontin/gabapentin and antidepressants for pain such as Cymbalta/duloxetine 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 the investigator
- Agree to see one physician (study physician) for knee pain during the study period
- Willing to utilize double barrier contraceptive method if of child bearing potential.
- Willing to delay any surgical intervention for the index knee for the period of the study follow up
- Willingness to provide informed consent and to comply with the requirements of this protocol for the full duration of the study
Who cannot join
- Evidence of inflammatory arthritis (for example, rheumatoid arthritis) or other systemic inflammatory condition (for example, gout, fibromyalgia) that could cause knee pain
- Evidence of neuropathic pain affecting the index knee
- Previous or pending lower limb amputation
- Intra-articular steroid injection into the index knee within 90 days from randomization
- Hyaluronic acid injection, platelet rich plasma (PRP), stem cell, or arthroscopic debridement/lavage injection into the index knee within 180 days from randomization
- Prior radiofrequency ablation of the genicular nerves of the index knee
Show all 25Show fewer
- Prior partial, resurfacing, or total knee arthroplasty of the index knee (residual hardware)
- Clinically significant ligamentous laxity of the index knee
- Clinically significant valgus/varus deformities or evidence of pathology (other than osteoarthritis of knee) that materially affects gait or function of the knee or is the underlying cause of the knee pain and/or functional limitations
- Body mass index (BMI) > 40 kg/m2
- Extremely thin patients and those with minimal subcutaneous tissue thickness that would not accommodate a radiofrequency 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)
- Pregnant, nursing or intent on 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 procedures, including known hypersensitivity (allergy) to hyaluronate preparations or allergies to avian or avian-derived products (including eggs, feathers, or poultry)
- Active joint infection or 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 that cannot be safely interrupted for procedure, 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 greater than 60 morphine equivalent daily opioid dose
- Uncontrolled immunosuppression (e.g. AIDS, cancer, diabetes, etc.)
- Subject currently implanted with pacemaker, stimulator 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
10 sites in 1 country.
10 sites in 1 country
United States10 sites
University Orthopedics Center
Altoona, Pennsylvania, 16602
Piedmont Comprehensive Pain Management
Anderson, South Carolina, 29621
University of Virginia
Charlottesville, Virginia, 22908
Lyman Medical Research
Coeur d'Alene, Idaho, 83814
Clinical Investigations, LLC
Edmond, Oklahoma, 73013
Ocshner Baptist Clinical Trials Unit
New Orleans, Louisiana, 70115
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Virginia iSpine Physicians
Richmond, Virginia, 23235
Mayo Clinic
Rochester, Minnesota, 55905
University Orthopedics Center
State College, Pennsylvania, 16801
About this study
Official title: A Prospective, Multi-center, Randomized, Clinical Trial Evaluating the Safety and Effectiveness of Using COOLIEF™ Cooled Radiofrequency Probe to Create Lesions of the Genicular Nerves and Comparing a Single Injection of Hyaluronic Acid in the Management of Knee Pain
This is a prospective, randomized, multicenter comparison study examining the outcomes of subjects with osteoarthritis and knee pain undergoing a procedure to create a radiofrequency lesion of the genicular nerves with the Cooled Radiofrequency Ablation (CRFA) system compared to subjects receiving Hyaluronic Acid (HA). Approximately 168 subjects will be enrolled into this study, with subjects undergoing either CRFA or HA injection in a 1:1 randomization scheme. Follow-up will be conducted for 12 months post-CRFA, with the primary endpoint being completed at month 6. Subjects randomized to the comparison (HA) group will have the option to cross-over to the neurotomy group after completing the 6-month endpoint assessment. They will 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 to determine success. Subjects who were randomized to and received COOLIEF* as their initial treatment will have the option to add 2 additional visits at 6-month intervals, representing 18 and 24 months post initial treatment.
Read the detailed description
The COOLIEF™ system components utilized in the study are the same in form and function regardless of specific product branding (COOLIEF* or SInergy*). The COOLIEF™ system is comprised of three primary components (collectively known as 'disposables') and is used in conjunction with the Pain Management generator, pump unit, connector cables (collectively known as 'Hardware') and dispersive electrodes (also known as 'grounding pads'):
- Cooled Radiofrequency Sterile Tube Kit (sterile, single use, non-body contact): It is used for closed-loop circulation of sterile water through a Halyard Health* Cooled Radiofrequency Probe. It includes a burette and tubing.
- Cooled Radiofrequency Introducer (sterile, single use): It is to be used with the Probes only. The Cooled Radiofrequency Introducer provides a path for the Probe to the targeted nervous tissue.
- Cooled Radiofrequency Probe (sterile, single use): It is inserted through an Introducer into or near nervous tissue. The active tip extends 4mm from the introducer and delivers energy. Sterile water circulates internally to cool the Probe while it delivers radiofrequency energy. A thermocouple in the Probe measures the cooled electrode temperature throughout the procedure.
The product is comprised of an electrically insulated shaft with an active tip that functions as an electrode for radiofrequency energy delivery, a handle, tubes with luer locks and a cable with a 7-pin connector. The Introducer includes an insulated stainless steel cannula and a stylet. The Tube Kit is comprised of a burette and flexible tubing fitted with luer locks for connection to the Probe. The Probe, Introducer, and Tube Kit are ethylene oxide sterilized and supplied sterile. These components can be packaged together in a kit or as separate components. The devices should be stored in a cool, dry environment. The Instructions For Use (IFU) documents (Appendix 1) are included in each kit.
Halyard Health maintains a list of all model numbers and sizes for the system components.
The control product/device, Synvisc-One® (hylan G-F 20) (HA), is an elastoviscous high molecular weight fluid containing hylan A and hylan B polymers produced from chicken combs. Hylans are derivatives of hyaluronan (sodium hyaluronate). Hylan G-F 20 is unique in that the hyaluronan is chemically crosslinked. Hyaluronan is a long-chain polymer containing repeating disaccharide units of Na-glucuronate-N-acetylglucosamine.
Synvisc-One is a single injection regimen therapy indicated for the treatment of pain in Osteoarthritis of the knee in patients who have failed to respond adequately to conservative nonpharmacologic therapy and simple analgesics, e.g., acetaminophen.
Following treatment, subjects in the CRF treatment group will follow up at 1, 3, 6 and 12 months. These subjects will then have the option to return for two additional visits at 18 and 24 months. Subjects initially randomized to the comparison (HA) group will follow up at 1, 3, and 6 months, and then be given the option to receive crossover CRF treatment. If crossover CRF treatment was received, subjects will return for follow up visits at 1, 3, and 6 months post-treatment. If crossover treatment was not received, subjects will return for their final 12 month visit.
Study Duration:
- Treatment Group: Up to 24 months following index procedure
- Control Group: Up to 13 months, depending upon receipt of cross-over procedure.
Effectiveness Endpoints:
- Numeric Rating Scale (NRS, Usual Level of Pain)
- Western Ontario \& McMaster University Osteoarthritis Index (WOMAC)
- EQ-5D-5L Health-Related Quality of Life Questionnaire
- Global Perceived Effect Scale
- Conditions
- Osteoarthritis of the Knee
- Being tested
- Cooled Radiofrequency, Hyaluronic Acid Injection, Crossover from Hyaluronic Acid Injection to Cooled Radiofrequency
- Keywords
- randomized clinical trial, osteoarthritis, radiofrequency ablation, knee, genicular, cross-over, viscosupplementation
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
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.
Hyaluronic Acid InjectionOther
Also called Viscosupplementation
Delivery of hyaluronic acid into knee by injection with needle to reduce knee pain.
Crossover from Hyaluronic Acid Injection to Cooled RadiofrequencyOther
Also called Viscosupplementation, Cooled Radiofrequency
Delivery of hyaluronic acid into knee by injection with needle to reduce knee pain. After 6 months, qualifying subjects in this group will have the option to crossover to receive cooled radiofrequency treatment.
| 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. Subjects in this group will be followed for 12 months post-procedure. Receives: Device: Cooled Radiofrequency |
| Hyaluronic Acid, then Cooled Radiofrequency | Active comparator | Hyaluronic acid injections will be administered to study subjects' knees to reduce knee pain. Subjects in this group will have the option to crossover to receive cooled radiofrequency after 6-months. Crossover subjects will be followed for an additional 6 months post-procedure. Non-crossover subjects will continue to be followed until the 12-month timepoint. Receives: Other: Hyaluronic Acid Injection; Other: Crossover from Hyaluronic Acid Injection to Cooled Radiofrequency |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Rating Scale (NRS)
The proportion of subjects whose knee pain is reduced by ≥ 50% based on the 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". There are no sub-scales.
Measured: Baseline to 6 month study visit
Safety: The Proportion of Subjects Experiencing Adverse Events Through Final Follow up.
Safety: The proportion of subjects experiencing adverse events through final follow up.
Measured: Baseline to 12 month study visit
Secondary outcomes (3)
Numeric Rating Scale
The proportion of subjects whose knee pain is reduced from baseline by ≥ 50% based on the 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". There are no sub-scales.
Measured: Baseline (or date of crossover for Crossover group subjects) to 12 month study visit
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
The change in WOMAC score from baseline to 6 months. This outcome instrument is composed of three sub-scales, including "Pain" (5 questions), "Stiffness" (2 questions), and "Physical Function" (17 questions). The point range for each sub-scale question is from 0 to 4, with "0" indicating the best study subject condition and "4" indicating the worst study subject condition. Thus, the minimum score per sub-scale is 0, and the maximum is 20, 8, and 68 for "Pain", Stiffness", and "Physical Function", respectively. The minimum and maximum possible scores for the entire instrument are 0 (best study subject condition) and 96 (worst study subject condition).
Measured: Baseline to 6 month study visit
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
The change in WOMAC score from baseline to 12 months. This outcome instrument is composed of three sub-scales, including "Pain" (5 questions), "Stiffness" (2 questions), and "Physical Function" (17 questions). The point range for each sub-scale question is from 0 to 4, with "0" indicating the best study subject condition and "4" indicating the worst study subject condition. Thus, the minimum score per sub-scale is 0, and the maximum is 20, 8, and 68 for "Pain", Stiffness", and "Physical Function", respectively. The minimum and maximum possible scores for the entire instrument are 0 (best study subject condition) and 96 (worst study subject condition).
Measured: Baseline (or date of crossover for Crossover group subjects) to 12 month study visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2017
- Study start7 Dec 2017
- Primary completion8 Feb 2019
- Study completion20 Jul 2020
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 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
- 177 participants (actual)
Sponsor and investigators
- Lead sponsor
- Avanos Medical
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antonia F Chen, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03381248
- Sponsor's protocol ID
- 105-17-0001
- Status last verified
- Sep 2023
- First submitted
- 18 Dec 2017
- Last updated
- 10 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Chen AF, Khalouf F, Zora K, DePalma M, Kohan L, Guirguis M, Beall D, Loudermilk E, Pingree MJ, Badiola I, Lyman J. Cooled radiofrequency ablation provides extended clinical utility in the management of knee osteoarthritis: 12-month results from a prospective, multi-center, randomized, cross-over trial comparing cooled radiofrequency ablation to a single hyaluronic acid injection. BMC Musculoskelet Disord. 2020 Jun 9;21(1):363. doi: 10.1186/s12891-020-03380-5.
PubMed 32517739
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-center, Randomized, Clinical Trial Evaluating the Safety and Effectiveness of Using COOLIEF™ Cooled Radiofrequency Probe to Create Lesions of the Genicular Nerves and Comparing a Single Injection of Hyaluronic Acid in the Management of Knee Pain
- ClinicalTrials.gov ID
- NCT03381248
- Acronym / sponsor ID
- 105-17-0001
- Conditions
- Osteoarthritis of the Knee
- Keywords
- randomized clinical trial, osteoarthritis, radiofrequency ablation, knee, genicular, cross-over, viscosupplementation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 177 participants (actual)
- Lead sponsor
- Avanos MedicalUniversity, hospital or other
- Study start
- 7 Dec 2017 (actual)
- Primary completion
- 8 Feb 2019 (actual)
- Study completion
- 20 Jul 2020 (actual)
- First posted
- 21 Dec 2017 (actual)
- Results
- Posted 22 May 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, randomized, multicenter comparison study examining the outcomes of subjects with osteoarthritis and knee pain undergoing a procedure to create a radiofrequency lesion of the genicular nerves with the Cooled Radiofrequency Ablation (CRFA) system compared to subjects receiving Hyaluronic Acid (HA). Approximately 168 subjects will be enrolled into this study, with subjects undergoing either CRFA or HA injection in a 1:1 randomization scheme. Follow-up will be conducted for 12 months post-CRFA, with the primary endpoint being completed at month 6. Subjects randomized to the comparison (HA) group will have the option to cross-over to the neurotomy group after completing the 6-month endpoint assessment. They will 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 to determine success. Subjects who were randomized to and received COOLIEF* as their initial treatment will have the option to add 2 additional visits at 6-month intervals, representing 18 and 24 months post initial treatment.
Detailed description
The COOLIEF™ system components utilized in the study are the same in form and function regardless of specific product branding (COOLIEF* or SInergy*). The COOLIEF™ system is comprised of three primary components (collectively known as 'disposables') and is used in conjunction with the Pain Management generator, pump unit, connector cables (collectively known as 'Hardware') and dispersive electrodes (also known as 'grounding pads'):
- Cooled Radiofrequency Sterile Tube Kit (sterile, single use, non-body contact): It is used for closed-loop circulation of sterile water through a Halyard Health* Cooled Radiofrequency Probe. It includes a burette and tubing.
- Cooled Radiofrequency Introducer (sterile, single use): It is to be used with the Probes only. The Cooled Radiofrequency Introducer provides a path for the Probe to the targeted nervous tissue.
- Cooled Radiofrequency Probe (sterile, single use): It is inserted through an Introducer into or near nervous tissue. The active tip extends 4mm from the introducer and delivers energy. Sterile water circulates internally to cool the Probe while it delivers radiofrequency energy. A thermocouple in the Probe measures the cooled electrode temperature throughout the procedure.
The product is comprised of an electrically insulated shaft with an active tip that functions as an electrode for radiofrequency energy delivery, a handle, tubes with luer locks and a cable with a 7-pin connector. The Introducer includes an insulated stainless steel cannula and a stylet. The Tube Kit is comprised of a burette and flexible tubing fitted with luer locks for connection to the Probe. The Probe, Introducer, and Tube Kit are ethylene oxide sterilized and supplied sterile. These components can be packaged together in a kit or as separate components. The devices should be stored in a cool, dry environment. The Instructions For Use (IFU) documents (Appendix 1) are included in each kit.
Halyard Health maintains a list of all model numbers and sizes for the system components.
The control product/device, Synvisc-One® (hylan G-F 20) (HA), is an elastoviscous high molecular weight fluid containing hylan A and hylan B polymers produced from chicken combs. Hylans are derivatives of hyaluronan (sodium hyaluronate). Hylan G-F 20 is unique in that the hyaluronan is chemically crosslinked. Hyaluronan is a long-chain polymer containing repeating disaccharide units of Na-glucuronate-N-acetylglucosamine.
Synvisc-One is a single injection regimen therapy indicated for the treatment of pain in Osteoarthritis of the knee in patients who have failed to respond adequately to conservative nonpharmacologic therapy and simple analgesics, e.g., acetaminophen.
Following treatment, subjects in the CRF treatment group will follow up at 1, 3, 6 and 12 months. These subjects will then have the option to return for two additional visits at 18 and 24 months. Subjects initially randomized to the comparison (HA) group will follow up at 1, 3, and 6 months, and then be given the option to receive crossover CRF treatment. If crossover CRF treatment was received, subjects will return for follow up visits at 1, 3, and 6 months post-treatment. If crossover treatment was not received, subjects will return for their final 12 month visit.
Study Duration:
- Treatment Group: Up to 24 months following index procedure
- Control Group: Up to 13 months, depending upon receipt of cross-over procedure.
Effectiveness Endpoints:
- Numeric Rating Scale (NRS, Usual Level of Pain)
- Western Ontario \& McMaster University Osteoarthritis Index (WOMAC)
- EQ-5D-5L Health-Related Quality of Life Questionnaire
- Global Perceived Effect Scale
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. Subjects in this group will be followed for 12 months post-procedure. |
| Hyaluronic Acid, then Cooled Radiofrequency | Active comparator | Other: Hyaluronic Acid Injection, Other: Crossover from Hyaluronic Acid Injection to Cooled RadiofrequencyHyaluronic acid injections will be administered to study subjects' knees to reduce knee pain. Subjects in this group will have the option to crossover to receive cooled radiofrequency after 6-months. Crossover subjects will be followed for an additional 6 months post-procedure. Non-crossover subjects will continue to be followed until the 12-month timepoint. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Age ≥ 21 years
- Able to understand the informed consent form and provide written informed consent and able to complete outcome measures
- Chronic knee pain for longer than 6 months that interferes with functional activities (for example, ambulation, prolonged standing, etc.)
- Continued pain in the target knee despite at least 3 months of conservative treatments, including activity modification, home exercise, protective weight bearing, and/or analgesics (for example, acetaminophen or non-steroidal anti-inflammatory drugs [NSAIDs])
- Positive response (defined as a decrease in numeric pain scores of at least 50%) to a single genicular nerve block of the index knee
Key exclusion criteria (25 listed)
- Evidence of inflammatory arthritis (for example, rheumatoid arthritis) or other systemic inflammatory condition (for example, gout, fibromyalgia) that could cause knee pain
- Evidence of neuropathic pain affecting the index knee
- Previous or pending lower limb amputation
- Intra-articular steroid injection into the index knee within 90 days from randomization
- Hyaluronic acid injection, platelet rich plasma (PRP), stem cell, or arthroscopic debridement/lavage injection into the index knee within 180 days from randomization
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 |
| Hyaluronic Acid InjectionAlso: ViscosupplementationDelivery of hyaluronic acid into knee by injection with needle to reduce knee pain. | Other | Hyaluronic Acid, then Cooled Radiofrequency |
| Crossover from Hyaluronic Acid Injection to Cooled RadiofrequencyAlso: Viscosupplementation, Cooled RadiofrequencyDelivery of hyaluronic acid into knee by injection with needle to reduce knee pain. After 6 months, qualifying subjects in this group will have the option to crossover to receive cooled radiofrequency treatment. | Other | Hyaluronic Acid, then Cooled Radiofrequency |
Primary outcome
Numeric Rating Scale (NRS)
Time frame: Baseline to 6 month study visit
The proportion of subjects whose knee pain is reduced by ≥ 50% based on the 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". There are no sub-scales.
Safety: The Proportion of Subjects Experiencing Adverse Events Through Final Follow up.
Time frame: Baseline to 12 month study visit
Safety: The proportion of subjects experiencing adverse events through final follow up.
3 secondary outcomes
Numeric Rating Scale
Time frame: Baseline (or date of crossover for Crossover group subjects) to 12 month study visit
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: Baseline to 6 month study visit
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: Baseline (or date of crossover for Crossover group subjects) to 12 month study visit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32517739Chen AF, Khalouf F, Zora K, DePalma M, Kohan L, Guirguis M, Beall D, Loudermilk E, Pingree MJ, Badiola I, Lyman J. Cooled radiofrequency ablation provides extended clinical utility in the management of knee osteoarthritis: 12-month results from a prospective, multi-center, randomized, cross-over trial comparing cooled radiofrequency ablation to a single hyaluronic acid injection. BMC Musculoskelet Disord. 2020 Jun 9;21(1):363. doi: 10.1186/s12891-020-03380-5.
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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.
Antonia F Chen, MD principal investigator
Brigham and Women's Hospital
10 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, Hyaluronic Acid Injection and Crossover from Hyaluronic Acid Injection to Cooled Radiofrequency in people with Osteoarthritis of the Knee, run by Avanos Medical at 10 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 14 inclusion and 25 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 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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 22 May 2020). 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: Baseline to 6 month study visit). 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 NCT03381248, 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 10 Oct 2023.