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Osteoarthritis of the KneeNCT04145011

Coolief Cooled Radiofrequency vs. Conventional Radiofrequency to Manage OA Knee Pain

A study testing Cooled Radiofrequency and Standard Radiofrequency in people with Osteoarthritis of the Knee, run by Avanos Medical at 7 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is being performed to assess the relative effectiveness of genicular nerve ablation with the COOLIEF* Cooled Radiofrequency probe to manage moderate to severe knee pain in patients with osteoarthritis (OA) of the knee when compared to radiofrequency ablation using a Standard Radiofrequency probe. 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 Standard Radiofrequency
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
153 participants
Where
7 sitesUnited States
Study dates
4 Oct 2019to 10 Oct 2022
Phase
Interventional
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 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 21 years
  • Able to understand and personally sign and date the informed consent form
  • 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
Show all 12Show fewer
  • Pain on NRS ≥ 6 on an 11-point scale for the index knee
  • Radiologic confirmation of osteoarthritis (x-ray/MRI/CT) grade 2 (mild), 3 (moderate) or 4 (severe) noted within 6 months for the index knee
  • 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
  • Subjects of child bearing potential must be willing to utilize double barrier contraceptive method
  • Willingness to comply with the requirements of this protocol for the full duration of the study (24 months regardless of effect of initial therapy)

Who cannot join

  • Evidence of inflammatory arthritis (example, rheumatoid arthritis) or other systemic inflammatory condition (example; gout, fibromyalgia, MS, Lupus, etc.) 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 of becoming pregnant during the study period
  • Chronic pain associated with significant psychosocial dysfunction
  • Poorly controlled severe psychiatric illness or ongoing psychological barriers to recovery, as determined by the investigator
  • Allergies to any of the medications to be used during the procedures
  • 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 mg 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 which included therapeutic treatment within 30 days prior to signing informed consent
  • Subject unwilling or unable to comply with follow up schedule, protocol requirements or procedures

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

United States7 sites

  • University Orthopedics Center

    Altoona, Pennsylvania, 16602

  • Piedmont Comprehensive Pain Management

    Anderson, South Carolina, 29621

  • The Spine and Nerve Centers of St. Francis Hosptial

    Charleston, West Virginia, 25301

  • University of Virginia

    Charlottesville, Virginia, 22903

  • University of Utah

    Salt Lake City, Utah, 84108

  • Pain Diagnostics and Interventional Care

    Sewickley, Pennsylvania, 15143

  • University Orthopedics Center

    State College, Pennsylvania, 16801

Other trials in United States

About this study

Official title: A Prospective, Multi-center, Randomized, Single Blind Clinical Trial Comparing COOLIEF* Cooled Radiofrequency to Conventional Radiofrequency Ablation of the Genicular Nerves in the Management of Knee Pain in an Osteoarthritic Patient Population

This study is being performed to assess the relative effectiveness of genicular nerve ablation with the COOLIEF* Cooled Radiofrequency probe to manage moderate to severe knee pain in patients with osteoarthritis (OA) of the knee when compared to radiofrequency ablation using a Standard Radiofrequency probe.

Read the detailed description

This is a prospective, multi-center, randomized, single-blind comparison study examining the outcomes of subjects with osteoarthritic knee pain undergoing a procedure to create a radiofrequency lesion of the genicular nerves with either Cooled Radiofrequency Ablation (CRFA) or Conventional (Standard) Radiofrequency Ablation (SRFA). Approximately 148 participants from up to 15 sites will be enrolled into this study, with subjects undergoing either CRFA or SRFA in a 1:1 randomization scheme. Follow-up will be conducted for 24 months post-treatment, with the primary endpoint being completed at month 12. Pain, overall outcome, quality of life, pain medication use, and adverse events will be compared between the two treatment groups to determine success.

Being tested
Cooled Radiofrequency, Standard Radiofrequency
Keywords
Randomized clinical trial, Osteoarthritis, Radiofrequency Ablation, Knee, Genicular, Coolief
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, CRFA

    Delivery of energy to ablate sensory nerves via cooled radiofrequency probe (18g, 4mm active tip)

  • Standard RadiofrequencyDevice

    Also called Conventional Radiofrequency, SRFA

    Delivery of energy to ablate sensory nerves via non-cooled standard radiofrequency probe (22g, curved 10mm active tip)

Study groups in NCT04145011
Study groupRoleWhat they receive
COOLIEF Cooled Radiofrequency ProbeExperimentalCooled radiofrequency energy will be delivered to the study subjects' knee to ablate culprit sensory nerves and reduce knee pain
Receives: Device: Cooled Radiofrequency
Conventional (Standard) Radiofrequency ProbeActive comparatorStandard (non-cooled) radiofrequency energy will be delivered to the study subjects' knee to ablate culprit sensory nerves and reduce knee pain
Receives: Device: Standard Radiofrequency

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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 "worst pain". There are no sub-scales.

    Measured: 12 months

Secondary outcomes (4)

  1. Additional Interventions

    The proportion of subjects requiring additional intervention for their OA knee pain.

    Measured: 12 months

  2. Knee injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR)

    The change in KOOS JR score from baseline. The KOOS JR is a short form of the KOOS that assesses patient stiffness (1 item), pain (4 items), and functions of daily living (2 items). Scores range from 0 to 100 with a score of 0 indicating total knee disability and 100 indicating perfect knee health.

    Measured: 12 months

  3. EQ-5D-5L

    The change in measured EQ-5D-5L scale from baseline. This outcome instrument is composed of five sub-scales containing five questions each. The point range for each sub-scale is from 1 to 5, with "1" indicating the best study subject condition and "5" indicating the worst study subject condition. Thus, the minimum and maximum scores per sub-scale are 1 and 5, respectively, and such scores for the entire instrument are 5 (best study subject condition) and 25 (worst study subject condition). The sub-scale topics are: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression

    Measured: 12 months

  4. Global Perceived Effect (GPE)

    The measured Global Perceived Effect scale. The Global Perceived Effect is a 7-point scale: 1 point = "worst ever", 2 points = "much worse", 3 points = "worse", 4 points = "not improved but not worse", 5 points = "improved", 6 points = "much improved", 7 points = "best ever". There are no sub-scales.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Oct 2019
  2. Study start4 Oct 2019
  3. Primary completion29 Oct 2021
  4. Study completion10 Oct 2022

Resources

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
Single blind
Who is masked
Participant
Enrolment
153 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04145011
Sponsor's protocol ID
105-18-0002
Status last verified
Aug 2023
First submitted
28 Oct 2019
Last updated
8 Aug 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Cooled Radiofrequency and Standard Radiofrequency in people with Osteoarthritis of the Knee, run by Avanos Medical at 7 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 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 8 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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: 12 months). 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 NCT04145011.

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 8 Aug 2023.

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