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| Name | Class |
|---|---|
| Abbott Medical Devices | INDUSTRY |
| Abbott | INDUSTRY |
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Chronic knee osteoarthritis (OA) is one of the most common diseases with increasing prevalence in advanced age. Knee OA results in movement restriction, sleep disturbance, and disability. Total knee arthroplasty (TKA) is employed often in the symptomatic treatment of knee OA. It has been estimated that 3.4 million TKAs will be performed in the year 2030 in the United States alone. Many studies report rewarding outcomes for patients, but other research shows there are many patients that remain dissatisfied post-arthroplasty.
The purpose of this study is to evaluate whether genicular radiofrequency ablation can relieve chronic post-arthroplasty knee pain.
Chronic knee osteoarthritis (OA) is one of the most common diseases with increasing prevalence in advanced age. Knee OA results in movement restriction, sleep disturbance, and disability. Total knee arthroplasty (TKA) is employed often in the symptomatic treatment of knee OA. It has been estimated that 3.4 million TKAs will be performed in the year 2030 in the United States alone. Many studies report rewarding outcomes for patients, but other research shows there are many patients that remain dissatisfied post-arthroplasty.
As the prevalence of knee arthroplasty increases, so does the frequency of revisions. It has been found that 20% of patients reporting painful knee arthroplasties were not able to be diagnosed with a specific cause and were therefore referred to a pain specialist. Pharmacologic therapy and non-surgical interventions are often employed with minimal benefit to the patient's level of disability as indicated by clinical evidence.
Genicular radiofrequency ablation seems to be a safe, effective and minimally invasive therapy for chronic knee OA patients who have had a positive diagnostic block. No study has determined whether genicular radiofrequency ablation can relieve chronic post-arthroplasty knee pain. The investigators propose to examine the effect of genicular radiofrequency ablation in chronic post-arthroplasty knee pain in patients who respond positively to diagnostic nerve blocks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nerve Block with Radiofrequency Ablation | Active Comparator | A 10 cm 18-gauge RF cannula with a 10 mm active tip will be placed at the superior lateral, superior medial, and inferior medial nerve positions under fluoroscopic guidance. Sensory stimulation at 50 Hz will be performed to identify nerve position and to assure no motor nerves will be ablated. Lidocaine (2 ml of 2%) will be administered in each location prior to RF generator activation. |
|
| Nerve Block with Sham Radiofrequency Ablation | Sham Comparator | A 10 cm 18-gauge RF cannula with a 10 mm active tip will be placed at the superior lateral, superior medial, and inferior medial nerve positions under fluoroscopic guidance.Control patients will undergo the same procedure without RF generator activation. Sensory stimulation at 50 Hz will be performed to identify nerve position and to assure no motor nerves will be ablated. Lidocaine (2 ml of 2%) will be administered in each location prior to RF generator sham activation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nerve Block with Radiofrequency Ablation | Procedure | Ablation of the genicular nerves of the knee by radiofrequency |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean difference in knee pain intensities as indicated on the Visual Analog Scale | Baseline and 6 weeks post-radiofrequency ablation |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Visual Analog Score of average knee pain | Baseline to 1 week, 6 weeks, and 12 weeks | |
| Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | Baseline to 1 week, 6 weeks, and 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Randall Brewer, MD | WK River Cities Clinical Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| WK River Cities Clinical Research Center | Shreveport | Louisiana | 71105 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17403800 | Background | Kurtz 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. | |
| 25232522 | Background | Nikolaou VS, Chytas D, Babis GC. Common controversies in total knee replacement surgery: Current evidence. World J Orthop. 2014 Sep 18;5(4):460-8. doi: 10.5312/wjo.v5.i4.460. eCollection 2014 Sep 18. |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D009407 | Nerve Block |
| D000078703 | Radiofrequency Ablation |
| ID | Term |
|---|---|
| D000765 | Anesthesia, Conduction |
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
| D003714 | Denervation |
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| Nerve Block with Sham Radiofrequency Ablation | Procedure | Genicular radiofrequency of the knee without neurotomy |
|
| Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) | Baseline to 1 week, 6 weeks, and 12 weeks |
| Change of Patient Global Assessment | Baseline to 1 week, 6 weeks, and 12 weeks |
| Satisfaction with Radiofrequency Procedure | Baseline to 1 week, 6 weeks, and 12 weeks |
| Rate of procedure-related Adverse Events | From informed consent through study completion, up to 20 weeks |
| Rate of Serious Adverse Events | From informed consent through study completion, up to 20 weeks |
| 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. |
| 22234706 | Background | Al-Hadithy N, Rozati H, Sewell MD, Dodds AL, Brooks P, Chatoo M. Causes of a painful total knee arthroplasty. Are patients still receiving total knee arthroplasty for extrinsic pathologies? Int Orthop. 2012 Jun;36(6):1185-9. doi: 10.1007/s00264-011-1473-6. Epub 2012 Jan 11. |
| D012216 |
| Rheumatic Diseases |
| D019635 |
| Neurosurgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D000078702 | Radiofrequency Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |