Osteoarthritis, Knee Clinical Trial
— DEFIANTOfficial title:
Radiofrequency For The Treatment Of Chronic Knee Pain Following Total Knee Arthroplasty: A Double-Blind Randomized Controlled Pilot Study
NCT number | NCT02931435 |
Other study ID # | GENRF |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | December 2016 |
Est. completion date | November 30, 2018 |
Verified date | December 2018 |
Source | Willis-Knighton River Cities Clinical Research Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 9 |
Est. completion date | November 30, 2018 |
Est. primary completion date | November 20, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years and older |
Eligibility |
Inclusion Criteria: - Study candidate must provide written informed consent. - Must be = 50 years of age at the time of consent - Chronic knee pain despite total knee arthroplasty at least 6 months prior to consent - Orthopedic evaluation indicating no further surgery is warranted - Stable pain medication regimen for 30 days prior to baseline visit - Knee pain is primary pain complaint Exclusion Criteria: - Acute knee pain - Connective tissue disorders affecting the knee - Serious neurologic or psychiatric disorders that would affect the outcome of the study as determined by the Principal Investigator - Steroid or hyaluronic acid injections into the affected knee in the past 3 months - Confounding pain conditions of the index leg that may affect medication requirements or study outcomes |
Country | Name | City | State |
---|---|---|---|
United States | WK River Cities Clinical Research Center | Shreveport | Louisiana |
Lead Sponsor | Collaborator |
---|---|
Randall Brewer, MD, CPI | Abbott, St. Jude Medical |
United States,
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. — View Citation
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):481-7. doi: 10.1016/j.pain.2010.09.029. Epub 2010 Nov 4. — View Citation
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. — View Citation
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. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mean difference in knee pain intensities as indicated on the Visual Analog Scale | Baseline and 6 weeks post-radiofrequency ablation | ||
Secondary | Change in Visual Analog Score of average knee pain | Baseline to 1 week, 6 weeks, and 12 weeks | ||
Secondary | Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | Baseline to 1 week, 6 weeks, and 12 weeks | ||
Secondary | Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) | Baseline to 1 week, 6 weeks, and 12 weeks | ||
Secondary | Change of Patient Global Assessment | Baseline to 1 week, 6 weeks, and 12 weeks | ||
Secondary | Satisfaction with Radiofrequency Procedure | Baseline to 1 week, 6 weeks, and 12 weeks | ||
Secondary | Rate of procedure-related Adverse Events | From informed consent through study completion, up to 20 weeks | ||
Secondary | Rate of Serious Adverse Events | From informed consent through study completion, up to 20 weeks |
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