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Due to financial constraints, sponsor could not complete the study.
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This is a single center randomized controlled trial. Approximately 102 patients will be randomized to one of two treatment groups: cooled radiofrequency or conventional monopolar radiofrequency ablation. Patients with chronic knee pain, with moderate to severe osteoarthritis according to the Kellgren-Lawrence scale for at least 6 months who have failed conservative therapy will be screened for the study.
Then, patients will be enrolled based on reporting ≥50% pain relief after a fluoroscopic guided single diagnostic block of the geniculate nerves (superior medial, superior lateral, and inferior medial) with 0.5 ml of local anesthetic (2% Lidocaine).
Baseline data will be collected for all enrolled patients. Outcomes will be measured at 1, 4, 12, 24 and 52 weeks.
Outcome measures will be: Visual analogue scale (VAS) both while at rest and during ambulation, Oxford knee scores, WOMAC, and global perceived effect.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cooled radiofrequency ablation | Active Comparator | Patient is placed in supine position on a fluoroscopic table with a pillow under the popliteal fossa. An anterio-posterior fluoroscopic view of the tibio-femoral joint is obtained. Skin and subcutaneous tissues are anesthetized and a 17 g introducer needle is advanced percutaneously towards the junction of shaft with epicondyle until bone contact is made. The needle is then laterally displaced away from the bone. This process is performed at the superior medial and superior lateral aspects of the femur, and the inferior medial aspect of the tibia. The fluoroscope is placed in lateral view to guide the needle depth to be at the medial third of the femur or tibia. A cooled radiofrequency probe from a Pain Management Radiofrequency kit is advanced through the introducer. Following sensory and motor stimulation, cooled genicular nerve radiofrequency ablation is carried out at 60 Celsius for 150 seconds. |
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| Monopolar radiofrequency ablation | Active Comparator | Patient is placed in supine position on a fluoroscopic table with a pillow under the popliteal fossa. An anterio-posterior fluoroscopic view of the tibio-femoral joint is obtained. Skin and subcutaneous tissues are anesthetized and a 16 g introducer needle is advanced percutaneously towards the junction of shaft with epicondyle until bone contact is made. The needle is then laterally displaced away from the bone. This process is performed at the superior medial and superior lateral aspects of the femur, and the inferior medial aspect of the tibia. The fluoroscope is placed in lateral view to guide the needle depth to be at the medial third of the femur or tibia. A conventional radiofrequency probe from a Pain Management Radiofrequency kit is advanced through the introducer. Following sensory and motor stimulation, genicular nerve radiofrequency ablation will be carried out at 80 Celsius for 90 seconds. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Genicular nerve radiofrequency ablation | Procedure | Radiofrequency ablation uses the electrical field generated by a radiofrequency probe inserted near a nerve responsible for pain. Chronic pain sensation in the knee is generated at the genicular nerves. The physician locates the affected genicular nerve by injecting an anesthetic (lidocaine) that produces a sensory nerve block (i.e. anesthetic pain relief). A radiofrequency probe is inserted percutaneously near the affected nerve using a cannula/introducer and is then connected to a radiofrequency generator. This is set to stimulate sensory and motor response, which allows the physician to adjust the probe position for effective and safe treatment. Then radiofrequency is applied to the tissue for a short time (up to 150 seconds) in order to generate a target temperature (no more than 80 degrees Celsius). The increase in the temperature of the tissue ablates the affected nerve producing pain relief. |
| Measure | Description | Time Frame |
|---|---|---|
| Evidence of Change in Knee Pain | A 100mm visual analog scale (VAS) score at 24 weeks post-treatment will be compared to baseline score to measure change in pain level. Change in Pain = (VAS at 24 weeks) - (VAS at baseline) The VAS consists of a 100 mm long line without marks between the 0 and 100 mm edges. Range of scale is 0 to 100 mm, where 0 means no pain and 100 mm means the worst pain imaginable. A negative change in VAS means a reduction in pain level after 24-weeks of treatment. | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Evidence of Functional Changes | Standard score system (Oxford Knee Score) was used to assess functional changes at 24 weeks of treatment relative to baseline. The Oxford Knee Score (OKS) measures the level of function, activities of daily living and how they have been affected by knee pain. The OKS is a obtained from a 12-item patient reported questionnaire. Each item has 5 categories, scored from 0 to 4, with 0 being the worst outcome and 4 the best outcome of each item. The OKS is the sum of all item scores. Therefore, it ranges from 0 to 48, with 0 being the worst functional outcome possible and 48 is the best functional outcome possible. Change in OKS = (OKS at 24 weeks) - (OKS at baseline) A positive Change in OKS indicates an improvement in extent of function. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ricardo Vallejo, MD, PhD | Millennium Pain Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Millennium Pain Center | Bloomington | Illinois | 61704 | United States | ||
| Millennium Pain Center at Decatur Memorial Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22446800 | Background | Murphy L, Helmick CG. The impact of osteoarthritis in the United States: a population-health perspective: A population-based review of the fourth most common cause of hospitalization in U.S. adults. Orthop Nurs. 2012 Mar-Apr;31(2):85-91. doi: 10.1097/NOR.0b013e31824fcd42. | |
| 17216685 | Background | Jordan JM, Helmick CG, Renner JB, Luta G, Dragomir AD, Woodard J, Fang F, Schwartz TA, Abbate LM, Callahan LF, Kalsbeek WD, Hochberg MC. Prevalence of knee symptoms and radiographic and symptomatic knee osteoarthritis in African Americans and Caucasians: the Johnston County Osteoarthritis Project. J Rheumatol. 2007 Jan;34(1):172-80. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cooled Radiofrequency Ablation | Radiofrequency ablation of the genicular nerves of osteoarthritic knee(s) using a cooled radiofrequency ablation probe |
| FG001 | Monopolar Radiofrequency Ablation |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 24, 2017 |
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| Pain Management Radiofrequency Kit | Device | The pain management radiofrequency consists of a radiofrequency generator, a radiofrequency probe and an introducer/cannula. The introducer cannula is used to percutaneously position the probe in the appropriate location for treatment. The radiofrequency probe is an electrode that delivers the electric field that heats up the tissue. In cooled radiofrequency the electrode is surrounded by a water jacket that cools it while heat is generated. The generator is the instrument that provides the radiofrequency according to a particular temperature and time program. Temperature, tissue impedance and radiofrequency power are lalso monitored by the generator. |
|
| 24 weeks |
| Decatur |
| Illinois |
| 62526 |
| United States |
| Methodist Comprehensive Spine and Pain Center - Millennium Pain Center | Peoria | Illinois | 61602 | United States |
| 11156538 | Background | Peat G, McCarney R, Croft P. Knee pain and osteoarthritis in older adults: a review of community burden and current use of primary health care. Ann Rheum Dis. 2001 Feb;60(2):91-7. doi: 10.1136/ard.60.2.91. |
| 21872812 | Background | Karaman H, Tufek A, Kavak GO, Yildirim ZB, Uysal E, Celik F, Kaya S. Intra-articularly applied pulsed radiofrequency can reduce chronic knee pain in patients with osteoarthritis. J Chin Med Assoc. 2011 Aug;74(8):336-40. doi: 10.1016/j.jcma.2011.06.004. Epub 2011 Jul 23. |
| 21055873 | Background | Choi WJ, Hwang SJ, Song JG, Leem JG, Kang YU, Park PH, Shin JW. Radiofrequency treatment relieves chronic knee osteoarthritis pain: a double-blind randomized controlled trial. Pain. 2011 Mar;152(3):481-487. doi: 10.1016/j.pain.2010.09.029. Epub 2010 Nov 4. |
| 21463469 | Background | Ikeuchi M, Ushida T, Izumi M, Tani T. Percutaneous radiofrequency treatment for refractory anteromedial pain of osteoarthritic knees. Pain Med. 2011 Apr;12(4):546-51. doi: 10.1111/j.1526-4637.2011.01086.x. Epub 2011 Apr 4. |
| 24781285 | Background | Vallejo R, Benyamin R, Tilley DM, Kelley CA, Cedeno DL. An ex vivo comparison of cooled-radiofrequency and bipolar-radiofrequency lesion size and the effect of injected fluids. Reg Anesth Pain Med. 2014 Jul-Aug;39(4):312-21. doi: 10.1097/AAP.0000000000000090. |
Radiofrequency ablation of the genicular nerves of osteoarthritic knee(s) using a monopolar radiofrequency ablation probe (16-gauge)
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Cooled Radiofrequency Ablation | Radiofrequency ablation of the genicular nerves of osteoarthritic knee(s) using a cooled radiofrequency ablation probe |
| BG001 | Monopolar Radiofrequency Ablation | Radiofrequency ablation of the genicular nerves of osteoarthritic knee(s) using a monopolar radiofrequency ablation probe (16-gauge) |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
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| Knee Pain VAS Score | The 100 mm Visual Analog Scale (VAS) was used to assess pain level by subjects. The scale consists of a 100 mm long line without marks between the 0 and 100 mm edges. Range of scale is 0 to 100 mm, where 0 means no pain and 100 mm means the worst pain imaginable. | Mean | Standard Deviation | mm |
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| Oxford Knee Score | The Oxford Knee Score (OKS) measures the level of function, activities of daily living and how they have been affected by knee pain over the preceding four weeks. The OKS is a obtained from a 12-item patient reported questionnaire. Each item has 5 categories, scored from 0 to 4, with 0 being the worst outcome and 4 the best outcome of each item. The OKS is the sum of all item scores. Therefore, it ranges from 0 to 48, with 0 being the worst functional outcome possible and 48 is the best functional outcome possible. | Mean | Standard Deviation | oxford knee score |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Evidence of Change in Knee Pain | A 100mm visual analog scale (VAS) score at 24 weeks post-treatment will be compared to baseline score to measure change in pain level. Change in Pain = (VAS at 24 weeks) - (VAS at baseline) The VAS consists of a 100 mm long line without marks between the 0 and 100 mm edges. Range of scale is 0 to 100 mm, where 0 means no pain and 100 mm means the worst pain imaginable. A negative change in VAS means a reduction in pain level after 24-weeks of treatment. | Posted | Mean | Standard Deviation | mm | 24 weeks | knees | knees |
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| Secondary | Evidence of Functional Changes | Standard score system (Oxford Knee Score) was used to assess functional changes at 24 weeks of treatment relative to baseline. The Oxford Knee Score (OKS) measures the level of function, activities of daily living and how they have been affected by knee pain. The OKS is a obtained from a 12-item patient reported questionnaire. Each item has 5 categories, scored from 0 to 4, with 0 being the worst outcome and 4 the best outcome of each item. The OKS is the sum of all item scores. Therefore, it ranges from 0 to 48, with 0 being the worst functional outcome possible and 48 is the best functional outcome possible. Change in OKS = (OKS at 24 weeks) - (OKS at baseline) A positive Change in OKS indicates an improvement in extent of function. | Posted | Mean | Standard Deviation | Oxford Knee Score | 24 weeks | knees | knees |
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Adverse events were collected since the start of enrollment and randomization until the 52 weeks follow up visit.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cooled Radiofrequency Ablation | Radiofrequency ablation of the genicular nerves of osteoarthritic knee(s) using a cooled radiofrequency ablation probe | 0 | 38 | 2 | 38 | 18 | 38 |
| EG001 | Monopolar Radiofrequency Ablation | Radiofrequency ablation of the genicular nerves of osteoarthritic knee(s) using a monopolar radiofrequency ablation probe (16-gauge) | 0 | 37 | 4 | 37 | 20 | 37 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | Non-systematic Assessment |
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| Broken Left Femur | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Hypokalemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Acute kidney injury | Renal and urinary disorders | Systematic Assessment |
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| Worsening of reflux esophagitis | Gastrointestinal disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Knee Pain or Swelling | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Other pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Bruised body parts | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Respiratory tract infections | Infections and infestations | Systematic Assessment |
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| Muscular issues | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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Early termination led to a number of subjects analyzed below the required statistical power to measure a significant difference between the means
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Cedeno | Lumbrera LLC | 3098266974 | dclumbrera@gmail.com |
| Sep 23, 2020 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| Participants |
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| knees |
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