Genicular Radiofrequency Ablation Efficacy in Achieving Total Knee Pain Reduction Trial

Osteoarthritis Clinical Trial

Official title:

GREAT Knee Pain Reduction Trial, Genicular Radiofrequency Ablation Efficacy in Achieving Total Knee Pain Reduction Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02947321
• Other study ID #: 160663
• Status: Completed
• Phase: N/A
• Start date: January 26, 2018
• Est. completion date: September 9, 2020

Study information

• Verified date: September 2020
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Given the benefits of genicular nerve radiofrequency ablation (RFA) in improving pain and functional status in non-surgical patients with knee osteoarthritis as well as the high prevalence of postoperative pain from total knee arthroplasty (TKA), this study is designed to determine the efficacy of preoperative genicular nerve RFA in improving acute and chronic postoperative pain as well as functional status in patients undergoing TKA. Patients will be randomized to one of two study arms: RFA group (genicular nerve thermal RFA) or control group (RFA needles placed in proper location without effective neurotomy).

Description:

Total knee arthroplasty (TKA) is a common and effective treatment for severe knee osteoarthritis. As the average age of the population increases in developed countries, the number of TKAs performed is projected to increase to 3.48 million procedures per year by 2030, a 673% increase from 2005. Although TKA is widely accepted as an efficacious form of treatment for severe knee osteoarthritis, the incidence of patient dissatisfaction and postoperative pain cannot be ignored. Genicular nerve RFA has been performed in non-surgical patients with chronic knee osteoarthritis with significant post procedure improvement in pain and functional status. This study is designed to determine the efficacy of preoperative genicular nerve RFA in improving acute and chronic postoperative pain as well as functional status in patients undergoing TKA.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 9, 2020
• Est. primary completion date: September 9, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 79 Years

Eligibility

Inclusion Criteria:

• Surgical candidate for total knee arthroplasty secondary to osteoarthritis

• Radiologic tibiofemoral osteoarthritis (Kellgren-Lawrence grade 2-4)

Exclusion Criteria:

• Worst knee pain score on day of evaluation <4/10

• Already taking opioids >100 mg/day of morphine equivalent dose

• Infectious etiology (over RFA insertion site or systemic)

• Workers compensation

• History of adverse reaction to local anesthetic or contrast

• History of intraarticular injection in the last 6 weeks with steroids or hyaluronic acids

• Prior total knee arthroplasty

• Prior open knee surgery or ligament reconstruction

• Prior RFA of knee joint

• Connective tissue diseases affecting the knee

• Sciatic pain

• Pacemaker

• Pregnancy

• Severe medical disease

• Serious neurological disorders

• Serious psychiatric disorders

• Suicidal or homicidal ideation

• BMI>50

Related Conditions & MeSH terms

• Knee Arthroplasty, Total
• Osteoarthritis
• Radiologic Tibiofemoral Osteoarthritis

Intervention

Procedure:
• Genicular Nerve RFA
Under fluoroscopic guidance, the target locations based on boney landmarks of the superior lateral (SL), superior medial (SM), and inferior medial (IL) branches of the genicular nerve will be determined. RFA probes will be placed and connected to the RFA generator and the generator is activated. The RFA is performed.
• Sham Genicular Nerve RFA
Under fluoroscopic guidance, the target locations based on boney landmarks of the superior lateral (SL), superior medial (SM), and inferior medial (IL) branches of the genicular nerve will be determined. The RFA probes for the control group will not be connected to the RFA generator (no neurotomy); however, the generator will still be activated to mimic the RFA group.

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center	Abbott Medical Devices

Country where clinical trial is conducted

United States, 

References & Publications (16)

Beswick AD, Wylde V, Gooberman-Hill R, Blom A, Dieppe P. What proportion of patients report long-term pain after total hip or knee replacement for osteoarthritis? A systematic review of prospective studies in unselected patients. BMJ Open. 2012 Feb 22;2(1):e000435. doi: 10.1136/bmjopen-2011-000435. Print 2012. — View Citation

Carr AJ, Robertsson O, Graves S, Price AJ, Arden NK, Judge A, Beard DJ. Knee replacement. Lancet. 2012 Apr 7;379(9823):1331-40. doi: 10.1016/S0140-6736(11)60752-6. Epub 2012 Mar 6. Review. — 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

Dunbar MJ, Richardson G, Robertsson O. I can't get no satisfaction after my total knee replacement: rhymes and reasons. Bone Joint J. 2013 Nov;95-B(11 Suppl A):148-52. doi: 10.1302/0301-620X.95B11.32767. Review. — View Citation

Grosu I, Lavand'homme P, Thienpont E. Pain after knee arthroplasty: an unresolved issue. Knee Surg Sports Traumatol Arthrosc. 2014 Aug;22(8):1744-58. doi: 10.1007/s00167-013-2750-2. Epub 2013 Nov 8. Review. — View Citation

Karaman H, Tüfek A, Kavak GÖ, 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. — 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

Lenguerrand E, Wylde V, Gooberman-Hill R, Sayers A, Brunton L, Beswick AD, Dieppe P, Blom AW. Trajectories of Pain and Function after Primary Hip and Knee Arthroplasty: The ADAPT Cohort Study. PLoS One. 2016 Feb 12;11(2):e0149306. doi: 10.1371/journal.pone.0149306. eCollection 2016. — View Citation

Puolakka PA, Rorarius MG, Roviola M, Puolakka TJ, Nordhausen K, Lindgren L. Persistent pain following knee arthroplasty. Eur J Anaesthesiol. 2010 May;27(5):455-60. doi: 10.1097/EJA.0b013e328335b31c. — View Citation

Singh JA, Lewallen DG. Are outcomes after total knee arthroplasty worsening over time? A time-trends study of activity limitation and pain outcomes. BMC Musculoskelet Disord. 2014 Dec 17;15:440. doi: 10.1186/1471-2474-15-440. — View Citation

Singh JA, Vessely MB, Harmsen WS, Schleck CD, Melton LJ 3rd, Kurland RL, Berry DJ. A population-based study of trends in the use of total hip and total knee arthroplasty, 1969-2008. Mayo Clin Proc. 2010 Oct;85(10):898-904. doi: 10.4065/mcp.2010.0115. Epub 2010 Sep 7. — View Citation

Skou ST, Roos EM, Laursen MB, Rathleff MS, Arendt-Nielsen L, Simonsen O, Rasmussen S. A Randomized, Controlled Trial of Total Knee Replacement. N Engl J Med. 2015 Oct 22;373(17):1597-606. doi: 10.1056/NEJMoa1505467. — View Citation

Srikandarajah S, Gilron I. Systematic review of movement-evoked pain versus pain at rest in postsurgical clinical trials and meta-analyses: a fundamental distinction requiring standardized measurement. Pain. 2011 Aug;152(8):1734-9. doi: 10.1016/j.pain.2011.02.008. Epub 2011 Mar 12. Review. — View Citation

Wylde V, Dieppe P, Hewlett S, Learmonth ID. Total knee replacement: is it really an effective procedure for all? Knee. 2007 Dec;14(6):417-23. Epub 2007 Jun 26. Review. — View Citation

Wylde V, Hewlett S, Learmonth ID, Dieppe P. Persistent pain after joint replacement: prevalence, sensory qualities, and postoperative determinants. Pain. 2011 Mar;152(3):566-72. doi: 10.1016/j.pain.2010.11.023. Epub 2011 Jan 15. — View Citation

Wylde V, Rooker J, Halliday L, Blom A. Acute postoperative pain at rest after hip and knee arthroplasty: severity, sensory qualities and impact on sleep. Orthop Traumatol Surg Res. 2011 Apr;97(2):139-44. doi: 10.1016/j.otsr.2010.12.003. Epub 2011 Mar 8. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of pain score at rest	Pain score at rest using an 11-point Pain Intensity Numerical Rating Scale (PI-NRS)	On the day of genicular nerve RFA or sham procedure, preoperatively on the day of surgery, on postoperative day 1 and 2, and at week 2, 6, 24, and 52.
Primary	Comparison of pain score with ambulation	Pain score with ambulation using an 11-point Pain Intensity Numerical Rating Scale (PI-NRS)	On the day of genicular nerve RFA or sham procedure, preoperatively on the day of surgery, on postoperative day 1 and 2, and at week 2, 6, 24, and 52.
Secondary	Comparison of PROMIS physical function score	Physical function assessment using the PROMIS physical function score	On the day of genicular nerve RFA or sham procedure, preoperatively on the day of surgery, and at week 2, 6, 24, and 52
Secondary	Comparison of PROMIS global health score	Global health assessment using the PROMIS global health score	On the day of genicular nerve RFA or sham procedure, preoperatively on the day of surgery, and at week 2, 6, 24, and 52
Secondary	Comparison of Knee Injury and Osteoarthritis Outcome Joint Replacement Score (KOOS JR)	Outcome assessment using the Knee Injury and Osteoarthritis Outcome Joint Replacement Score (KOOS JR)	On the day of genicular nerve RFA or sham procedure, preoperatively on the day of surgery, and at week 2, 6, 24, and 52
Secondary	Comparison of 7-point Patient Global Impression of Change (PGIC)	Assessment of the subject's belief about the efficacy of treatment using the PGIC.	Preoperatively on the day of surgery, and at week 2, 6, 24, and 52
Secondary	Comparison of Mobility using Timed Up and Go Test (TUG)	Assessment of mobility using the TUG test	Day of genicular RFA or sham procedure, and postoperative day 1
Secondary	Comparison of Depression assessment using Center for Epidemiologic Studies Depression Scale (CES-D)	Screening for depression using the CES-D	Day of genicular RFA or sham procedure and at 6 weeks postoperatively
Secondary	Comparison of Total opioid use in morphine equivalents		Day of genicular RFA or sham procedure, day of surgery, post op dy 1 and 2, and at weeks 2,6 postoperatively
Secondary	Assessment of pain location using Michigan Body Map		Day of genicular nerve RFA
Secondary	Assessment of pain catastrophizing using Catastrophizing General Chronic Pain (CAT) Scale		Day of genicular RFA or sham procedure
Secondary	Comparison of quadriceps strength		Day of genicular RFA or sham procedure, and at weeks 2 and 6 postoperatively
Secondary	Comparison Range of Motion - Knee		Day of genicular RFA or sham procedure, and at weeks 2 and 6 postoperatively