Radiofrequency For Chronic Knee Pain Post-Arthroplasty

Osteoarthritis, Knee Clinical Trial

— DEFIANT  

Official title:

Radiofrequency For The Treatment Of Chronic Knee Pain Following Total Knee Arthroplasty: A Double-Blind Randomized Controlled Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02931435
• Other study ID #: GENRF
• Status: Completed
• Phase: N/A
• Start date: December 2016
• Est. completion date: November 30, 2018

Study information

• Verified date: December 2018
• Source: Willis-Knighton River Cities Clinical Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Chronic Knee Pain
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Procedure:
• Nerve Block with Radiofrequency Ablation
Ablation of the genicular nerves of the knee by radiofrequency
• Nerve Block with Sham Radiofrequency Ablation
Genicular radiofrequency of the knee without neurotomy

Locations

Country	Name	City	State
United States	WK River Cities Clinical Research Center	Shreveport	Louisiana

Sponsors (3)

Lead Sponsor	Collaborator
Randall Brewer, MD, CPI	Abbott, St. Jude Medical

Country where clinical trial is conducted

United States, 

References & Publications (4)

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

Outcome

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