Osteoarthritis of the KneeRFANCT02925442
Genicular Radiofrequency Ablation for Unilateral Knee Arthroplasty Pain Management
A study testing t-RFA and C-RFA in people with Osteoarthritis of the Knee, run by Lyman Medical Research Foundation, Inc. at 2 sites in United States.
Trial summary
Three primary reasons prolong hospital stays following unilateral knee arthroplasty. Pain is the primary reason followed by opioid drowsiness and nausea/vomiting side effects. Standard genicular radiofrequency ablation (t-RFA) has been effective pain management for non-operative knee pain associated with… Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis of the Knee
- What is being tested?
- t-RFA and C-RFA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 2 sitesUnited States
- Study dates
- 25 Jan 2017to 7 Feb 2020
- 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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Osteoarthritis of the knee where unilateral knee arthroplasty is indicated by radiograph, function decrease and/or pain indication and readiness to undergo t-RFA, C-RFA or sham treatment.
Who cannot join
- □ • NO DAILY OPIOID CONSUMPTION 5 WEEKS PRIOR TO ENROLLMENT
- NO DOCUMENTED NARCOTIC DEPENDENCY OR RECREATIONAL DRUG USE
- NO TOBACCO USAGE WITHIN 2 MONTHS PRIOR TO SURGERY
- NO CONFOUNDING INFLAMMATORY ARTHRITIS DISEASES ARE PRESENT
- NO NEUROPATHY OR NEURO IMPAIRMENT PRESENT
- NO SIGNIFICANT ACUTE ILLNESS OR INFECTION
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- NO OTHER CONFOUNDING CHRONIC PAIN
- NO INVESTIGATIONAL AGENT WITHIN 3 MONTHS PRIOR TO ENROLLMENT
- NO DIAGNOSED THROMBOPHILIA
- NO SEVERE CARDIAC OR PULMONARY COMPROMISE
- NO BLEEDING DISORDER(S)
- NO ALLERGIC REACTION TO LOCAL ANESTHESIA, STEROIDS, OR IMPLANT MATERIALS
- NO BREASTFEEDING
- NO PREGNANCY
- NO CONFOUNDING PSYCHIATRIC ILLNESSES
- NO CONFOUNDING MAJOR TRAUMA HARDWARE REMOVALS OR PRIOR TKA *NO CONTRAINDICATED BODY HABITUS TO BE DETERMINED BY A TREATMENT PROVIDER
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Orthopedic Specialty Institute
Coeur d'Alene, Idaho, 83814
Orthopedic Specialty Institute
Spokane, Washington, 99202
About this study
Official title: Comparison Between Cooled (C-RFA) and Standard (t-RFA) Radiofrequency Ablation, and Control for Pain Management Following Unilateral Knee Arthroplasty: A Double-Blinded, Parallel-Grouped, Placebo-Controlled Randomized Clinical Trial
Three primary reasons prolong hospital stays following unilateral knee arthroplasty. Pain is the primary reason followed by opioid drowsiness and nausea/vomiting side effects. Standard genicular radiofrequency ablation (t-RFA) has been effective pain management for non-operative knee pain associated with osteoarthritis. Additionally, cooled radiofrequency ablation (C-RFA), is now available for knee pain management. Both t-RFA and C-RFA offer minimally invasive, non-surgical, non-opioid pain relief options following surgery. The study will perform a double-blinded, parallel grouped, placebo-controlled randomized study to compare three pain management paradigms involving preoperative genicular C-RFA, t-RFA, and control placebo/sham. The aim of this study is to establish if C-RFA and t-RFA, offered preoperatively to patients undergoing unilateral knee arthroplasty, provide postoperative pain relief.
Read the detailed description
Total knee replacements are a leading orthopedic procedure in the United States totaling 600,000 in 2010, and are anticipated to grow to 3.48 million procedures by 2030. Three primary reasons prolong hospital stays following unilateral knee arthroplasty. Pain is the primary reason followed by opioid drowsiness and nausea/vomiting side effects. Reducing opioid usage and decreasing hospital length of stays are paramount in improving patient care during recovery and rehabilitation, subsequently reducing overall costs associated with total knee replacement. Standard genicular radiofrequency ablation (t-RFA) has been effective pain management for non-operative knee pain associated with osteoarthritis. Additionally, cooled radiofrequency ablation (C-RFA), which was previously used for spinal pain, is now available for knee pain management. C-RFA, compared to t-RFA, causes large volume spherical lesions and potentially reduces time and fluoroscopic exposure with direct placement techniques. However, both t-RFA and C-RFA offer a minimally invasive, non-surgical, non-opioid pain relief options following surgery. Preliminary reports involving 40 patients who underwent either C-RFA or t-RFA prior to unilateral knee arthroplasty by the investigator indicate both procedures improved postoperative pain assessments and decreased opioid/narcotic utilization. The study will perform a double-blinded, parallel grouped, placebo-controlled randomized study to compare three pain management paradigms involving preoperative C-RFA, t-RFA, and sham. The aim of this study is to establish if C-RFA and t-RFA, offered preoperatively to patients undergoing unilateral knee arthroplasty, provide postoperative pain relief, reduce hospital length of stays and decrease opioid utilization thereby improving patient outcomes and decreasing overall costs.
- Conditions
- Osteoarthritis of the Knee
- Being tested
- t-RFA, C-RFA, Control
- Keywords
- Unilateral Knee Arthroplasty, Radiofrequency Ablation, Genicular, RFA, C-RFA, t-RFA, total knee replacement
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
t-RFAProcedure or surgery
Also called Standard thermal genicular radiofrequency ablation
standard thermal genicular radiofrequency ablation
C-RFAProcedure or surgery
Also called Coolief radiofrequency ablation
Cooled radiofrequency ablation
ControlProcedure or surgery
Also called Placebo Sham
Simulated radiofrequency ablation for placebo controlled group
| Study group | Role | What they receive |
|---|---|---|
| Standard Thermal radiofrequency ablation | Experimental | Patients randomized to t-RFA will receive standard genicular thermal radiofrequency ablation at least 3 weeks prior to unilateral knee arthroplasty for postoperative pain management. Receives: Procedure: t-RFA |
| Cooled radiofrequency ablation | Experimental | Patients randomized to C-RFA will receive cooled genicular thermal radiofrequency ablation at least 3 weeks prior to unilateral knee arthroplasty for postoperative pain management. Receives: Procedure: C-RFA |
| Control:Placebo Sham | Sham comparator | Patients randomized to control will receive simulated genicular thermal radiofrequency ablation at least 3 weeks prior to unilateral knee arthroplasty and receive the industry standard of care for unilateral knee arthroplasty pain management. Receives: Procedure: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative analgesic consumption
Measure opioid consumption for the three study arms
Measured: 0 - 3 weeks postoperatively
Hospital Length of Stay (LOS)
Measure hospital length of stay for the three study arms
Measured: 0-5 days postoperatively
Secondary outcomes (1)
Pain Score
assess patient pain score diaries after total knee replacement for the three treatment arms
Measured: before treatment arm procedures to 12 months after unilateral knee arthroplasty
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2016 (estimated)
- Study start25 Jan 2017
- Primary completion7 Jan 2020 (estimated)
- Study completion7 Feb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)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
- Model description
- Genicular radiofrequency ablation performed prior to total knee arthroplasty for pain management
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lyman Medical Research Foundation, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Halyard Health
- Responsible party
- Sponsor
- Investigators
- Jeffrey Lyman, MD, Principal investigator, Orthopedic Specialty InstituteTimothy Lovell, MD, Principal investigator, Providence Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02925442
- Sponsor's protocol ID
- OSI-0002
- Acronym
- RFA
- Status last verified
- May 2019
- First submitted
- 3 Oct 2016
- Last updated
- 24 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Schiltenwolf M, Fischer C. Choi WJ et al. Radiofrequency treatment relieves chronic knee osteoarthritis pain: a double-blind randomized controlled trial. Pain 2011; 152: 481-7. Pain. 2011 Aug;152(8):1933-1934. doi: 10.1016/j.pain.2011.05.031. Epub 2011 Jun 22. No abstract available.
PubMed 21700390Husted H, Lunn TH, Troelsen A, Gaarn-Larsen L, Kristensen BB, Kehlet H. Why still in hospital after fast-track hip and knee arthroplasty? Acta Orthop. 2011 Dec;82(6):679-84. doi: 10.3109/17453674.2011.636682. Epub 2011 Nov 9.
PubMed 22066560Kurtz S, Ong K, Lau E, Mowat F, Halpern M. Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. J Bone Joint Surg Am. 2007 Apr;89(4):780-5. doi: 10.2106/JBJS.F.00222.
PubMed 17403800Patel A, Pavlou G, Mujica-Mota RE, Toms AD. The epidemiology of revision total knee and hip arthroplasty in England and Wales: a comparative analysis with projections for the United States. A study using the National Joint Registry dataset. Bone Joint J. 2015 Aug;97-B(8):1076-81. doi: 10.1302/0301-620X.97B8.35170.
PubMed 26224824Stelzer W, Aiglesberger M, Stelzer D, Stelzer V. Use of cooled radiofrequency lateral branch neurotomy for the treatment of sacroiliac joint-mediated low back pain: a large case series. Pain Med. 2013 Jan;14(1):29-35. doi: 10.1111/pme.12014. Epub 2012 Dec 28.
PubMed 23279364Lyman JR, Olscamp AJ, Lovell TP, Winegar CD, Wilson AN. Radiofrequency ablation prior to total knee arthroplasty does not improve post-surgical pain or recovery: a double-blinded, multi-center, randomized clinical trial. Ann Jt. 2023 Jan 15;8:5. doi: 10.21037/aoj-22-33. eCollection 2023.
PubMed 38529234
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Cooled (C-RFA) and Standard (t-RFA) Radiofrequency Ablation, and Control for Pain Management Following Unilateral Knee Arthroplasty: A Double-Blinded, Parallel-Grouped, Placebo-Controlled Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02925442
- Acronym / sponsor ID
- RFA / OSI-0002
- Conditions
- Osteoarthritis of the Knee
- Keywords
- Unilateral Knee Arthroplasty, Radiofrequency Ablation, Genicular, RFA, C-RFA, t-RFA, total knee replacement
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Lyman Medical Research Foundation, Inc.University, hospital or other
- Collaborators
- Halyard Health
- Study start
- 25 Jan 2017 (actual)
- Primary completion
- 7 Jan 2020 (estimated)
- Study completion
- 7 Feb 2020 (estimated)
- First posted
- 5 Oct 2016 (estimated)
- 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.
Three primary reasons prolong hospital stays following unilateral knee arthroplasty. Pain is the primary reason followed by opioid drowsiness and nausea/vomiting side effects. Standard genicular radiofrequency ablation (t-RFA) has been effective pain management for non-operative knee pain associated with osteoarthritis. Additionally, cooled radiofrequency ablation (C-RFA), is now available for knee pain management. Both t-RFA and C-RFA offer minimally invasive, non-surgical, non-opioid pain relief options following surgery. The study will perform a double-blinded, parallel grouped, placebo-controlled randomized study to compare three pain management paradigms involving preoperative genicular C-RFA, t-RFA, and control placebo/sham. The aim of this study is to establish if C-RFA and t-RFA, offered preoperatively to patients undergoing unilateral knee arthroplasty, provide postoperative pain relief.
Detailed description
Total knee replacements are a leading orthopedic procedure in the United States totaling 600,000 in 2010, and are anticipated to grow to 3.48 million procedures by 2030. Three primary reasons prolong hospital stays following unilateral knee arthroplasty. Pain is the primary reason followed by opioid drowsiness and nausea/vomiting side effects. Reducing opioid usage and decreasing hospital length of stays are paramount in improving patient care during recovery and rehabilitation, subsequently reducing overall costs associated with total knee replacement. Standard genicular radiofrequency ablation (t-RFA) has been effective pain management for non-operative knee pain associated with osteoarthritis. Additionally, cooled radiofrequency ablation (C-RFA), which was previously used for spinal pain, is now available for knee pain management. C-RFA, compared to t-RFA, causes large volume spherical lesions and potentially reduces time and fluoroscopic exposure with direct placement techniques. However, both t-RFA and C-RFA offer a minimally invasive, non-surgical, non-opioid pain relief options following surgery. Preliminary reports involving 40 patients who underwent either C-RFA or t-RFA prior to unilateral knee arthroplasty by the investigator indicate both procedures improved postoperative pain assessments and decreased opioid/narcotic utilization. The study will perform a double-blinded, parallel grouped, placebo-controlled randomized study to compare three pain management paradigms involving preoperative C-RFA, t-RFA, and sham. The aim of this study is to establish if C-RFA and t-RFA, offered preoperatively to patients undergoing unilateral knee arthroplasty, provide postoperative pain relief, reduce hospital length of stays and decrease opioid utilization thereby improving patient outcomes and decreasing overall costs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- Genicular radiofrequency ablation performed prior to total knee arthroplasty for pain management
| Arm | Type | Receives |
|---|---|---|
| Standard Thermal radiofrequency ablation | Experimental | Procedure: t-RFAPatients randomized to t-RFA will receive standard genicular thermal radiofrequency ablation at least 3 weeks prior to unilateral knee arthroplasty for postoperative pain management. |
| Cooled radiofrequency ablation | Experimental | Procedure: C-RFAPatients randomized to C-RFA will receive cooled genicular thermal radiofrequency ablation at least 3 weeks prior to unilateral knee arthroplasty for postoperative pain management. |
| Control:Placebo Sham | Sham comparator | Procedure: ControlPatients randomized to control will receive simulated genicular thermal radiofrequency ablation at least 3 weeks prior to unilateral knee arthroplasty and receive the industry standard of care for unilateral knee arthroplasty pain management. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Osteoarthritis of the knee where unilateral knee arthroplasty is indicated by radiograph, function decrease and/or pain indication and readiness to undergo t-RFA, C-RFA or sham treatment.
Key exclusion criteria (16 listed)
- □ • NO DAILY OPIOID CONSUMPTION 5 WEEKS PRIOR TO ENROLLMENT
- NO DOCUMENTED NARCOTIC DEPENDENCY OR RECREATIONAL DRUG USE
- NO TOBACCO USAGE WITHIN 2 MONTHS PRIOR TO SURGERY
- NO CONFOUNDING INFLAMMATORY ARTHRITIS DISEASES ARE PRESENT
- NO NEUROPATHY OR NEURO IMPAIRMENT PRESENT
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 |
|---|---|---|
| t-RFAAlso: Standard thermal genicular radiofrequency ablationstandard thermal genicular radiofrequency ablation | Procedure or surgery | Standard Thermal radiofrequency ablation |
| C-RFAAlso: Coolief radiofrequency ablationCooled radiofrequency ablation | Procedure or surgery | Cooled radiofrequency ablation |
| ControlAlso: Placebo ShamSimulated radiofrequency ablation for placebo controlled group | Procedure or surgery | Control:Placebo Sham |
Primary outcome
Postoperative analgesic consumption
Time frame: 0 - 3 weeks postoperatively
Measure opioid consumption for the three study arms
Hospital Length of Stay (LOS)
Time frame: 0-5 days postoperatively
Measure hospital length of stay for the three study arms
1 secondary outcome
Pain Score
Time frame: before treatment arm procedures to 12 months after unilateral knee arthroplasty
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2019.
- Background: PubMed 21700390Schiltenwolf M, Fischer C. Choi WJ et al. Radiofrequency treatment relieves chronic knee osteoarthritis pain: a double-blind randomized controlled trial. Pain 2011; 152: 481-7. Pain. 2011 Aug;152(8):1933-1934. doi: 10.1016/j.pain.2011.05.031. Epub 2011 Jun 22. No abstract available.
- Background: PubMed 22066560Husted H, Lunn TH, Troelsen A, Gaarn-Larsen L, Kristensen BB, Kehlet H. Why still in hospital after fast-track hip and knee arthroplasty? Acta Orthop. 2011 Dec;82(6):679-84. doi: 10.3109/17453674.2011.636682. Epub 2011 Nov 9.
- Background: PubMed 17403800Kurtz S, Ong K, Lau E, Mowat F, Halpern M. Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. J Bone Joint Surg Am. 2007 Apr;89(4):780-5. doi: 10.2106/JBJS.F.00222.
- Background: PubMed 26224824Patel A, Pavlou G, Mujica-Mota RE, Toms AD. The epidemiology of revision total knee and hip arthroplasty in England and Wales: a comparative analysis with projections for the United States. A study using the National Joint Registry dataset. Bone Joint J. 2015 Aug;97-B(8):1076-81. doi: 10.1302/0301-620X.97B8.35170.
- Background: PubMed 23279364Stelzer W, Aiglesberger M, Stelzer D, Stelzer V. Use of cooled radiofrequency lateral branch neurotomy for the treatment of sacroiliac joint-mediated low back pain: a large case series. Pain Med. 2013 Jan;14(1):29-35. doi: 10.1111/pme.12014. Epub 2012 Dec 28.
- Derived from this study: PubMed 38529234Lyman JR, Olscamp AJ, Lovell TP, Winegar CD, Wilson AN. Radiofrequency ablation prior to total knee arthroplasty does not improve post-surgical pain or recovery: a double-blinded, multi-center, randomized clinical trial. Ann Jt. 2023 Jan 15;8:5. doi: 10.21037/aoj-22-33. eCollection 2023.
- Individual participant dataSharing planned: Undecided
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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.
Jeffrey Lyman, MD principal investigator
Orthopedic Specialty Institute
Timothy Lovell, MD principal investigator
Providence Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing t-RFA and C-RFA in people with Osteoarthritis of the Knee, run by Lyman Medical Research Foundation, Inc. at 2 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 1 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 24 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 2 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. 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?
Results are not available in the source record.
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?
Postoperative analgesic consumption (time frame: 0 - 3 weeks postoperatively). 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 NCT02925442, which also lists 6 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 24 May 2019.