Clinical trial NCT02925442: Genicular Radiofrequency Ablation for Unilateral Knee Arthroplasty Pain Management
Official title: Comparison Between Cooled (C-RFA) and Standard (t-RFA) Radiofrequency Ablation, and Control for Pain Management Following Unilateral Knee Arthroplasty: A Double-Blinded, Parallel-Grouped, Placebo-Controlled Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoarthritis of the Knee
Keywords: Unilateral Knee Arthroplasty
Radiofrequency Ablation
Genicular
RFA
C-RFA
t-RFA
total knee replacement
Lead sponsor: Lyman Medical Research Foundation, Inc.
Sponsor class: OTHER
Collaborators: name: Halyard Health
First posted: 2016-10-05
Enrollment: 150
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Genicular radiofrequency ablation performed prior to total knee arthroplasty for pain management
Primary purpose: TREATMENT

Brief summary: Three primary reasons prolong hospital stays following unilateral knee arthroplasty. Pain is the primary reason followed by opioid drowsiness and nausea/vomiting side effects. Standard genicular radiofrequency ablation (t-RFA) has been effective pain management for non-operative knee pain associated with osteoarthritis. Additionally, cooled radiofrequency ablation (C-RFA), is now available for knee pain management. Both t-RFA and C-RFA offer minimally invasive, non-surgical, non-opioid pain relief options following surgery. The study will perform a double-blinded, parallel grouped, placebo-controlled randomized study to compare three pain management paradigms involving preoperative genicular C-RFA, t-RFA, and control placebo/sham. The aim of this study is to establish if C-RFA and t-RFA, offered preoperatively to patients undergoing unilateral knee arthroplasty, provide postoperative pain relief.

Detailed description: Total knee replacements are a leading orthopedic procedure in the United States totaling 600,000 in 2010, and are anticipated to grow to 3.48 million procedures by 2030. Three primary reasons prolong hospital stays following unilateral knee arthroplasty. Pain is the primary reason followed by opioid drowsiness and nausea/vomiting side effects. Reducing opioid usage and decreasing hospital length of stays are paramount in improving patient care during recovery and rehabilitation, subsequently reducing overall costs associated with total knee replacement. Standard genicular radiofrequency ablation (t-RFA) has been effective pain management for non-operative knee pain associated with osteoarthritis. Additionally, cooled radiofrequency ablation (C-RFA), which was previously used for spinal pain, is now available for knee pain management. C-RFA, compared to t-RFA, causes large volume spherical lesions and potentially reduces time and fluoroscopic exposure with direct placement techniques. However, both t-RFA and C-RFA offer a minimally invasive, non-surgical, non-opioid pain relief options following surgery. Preliminary reports involving 40 patients who underwent either C-RFA or t-RFA prior to unilateral knee arthroplasty by the investigator indicate both procedures improved postoperative pain assessments and decreased opioid/narcotic utilization. The study will perform a double-blinded, parallel grouped, placebo-controlled randomized study to compare three pain management paradigms involving preoperative C-RFA, t-RFA, and sham. The aim of this study is to establish if C-RFA and t-RFA, offered preoperatively to patients undergoing unilateral knee arthroplasty, provide postoperative pain relief, reduce hospital length of stays and decrease opioid utilization thereby improving patient outcomes and decreasing overall costs.

Eligibility criteria: Inclusion Criteria:

* Osteoarthritis of the knee where unilateral knee arthroplasty is indicated by radiograph, function decrease and/or pain indication and readiness to undergo t-RFA, C-RFA or sham treatment.

Exclusion Criteria:

□ • NO DAILY OPIOID CONSUMPTION 5 WEEKS PRIOR TO ENROLLMENT

* NO DOCUMENTED NARCOTIC DEPENDENCY OR RECREATIONAL DRUG USE
* NO TOBACCO USAGE WITHIN 2 MONTHS PRIOR TO SURGERY
* NO CONFOUNDING INFLAMMATORY ARTHRITIS DISEASES ARE PRESENT
* NO NEUROPATHY OR NEURO IMPAIRMENT PRESENT
* NO SIGNIFICANT ACUTE ILLNESS OR INFECTION
* NO OTHER CONFOUNDING CHRONIC PAIN
* NO INVESTIGATIONAL AGENT WITHIN 3 MONTHS PRIOR TO ENROLLMENT
* NO DIAGNOSED THROMBOPHILIA
* NO SEVERE CARDIAC OR PULMONARY COMPROMISE
* NO BLEEDING DISORDER(S)
* NO ALLERGIC REACTION TO LOCAL ANESTHESIA, STEROIDS, OR IMPLANT MATERIALS
* NO BREASTFEEDING
* NO PREGNANCY
* NO CONFOUNDING PSYCHIATRIC ILLNESSES
* NO CONFOUNDING MAJOR TRAUMA HARDWARE REMOVALS OR PRIOR TKA \*NO CONTRAINDICATED BODY HABITUS TO BE DETERMINED BY A TREATMENT PROVIDER

Primary outcomes:
measure: Postoperative analgesic consumption
timeFrame: 0 - 3 weeks postoperatively
measure: Hospital Length of Stay (LOS)
timeFrame: 0-5 days postoperatively
Secondary outcomes:
measure: Pain Score
timeFrame: before treatment arm procedures to 12 months after unilateral knee arthroplasty
Other outcomes:
Locations:
city: Coeur d'Alene
country: United States
facility: Orthopedic Specialty Institute
state: Idaho
city: Spokane
country: United States
facility: Orthopedic Specialty Institute
state: Washington
Study officials:
affiliation: Orthopedic Specialty Institute
name: Jeffrey Lyman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Providence Medical Center
name: Timothy Lovell, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schiltenwolf M, Fischer C. Choi WJ et al. Radiofrequency treatment relieves chronic knee osteoarthritis pain: a double-blind randomized controlled trial. Pain 2011; 152: 481-7. Pain. 2011 Aug;152(8):1933-1934. doi: 10.1016/j.pain.2011.05.031. Epub 2011 Jun 22. No abstract available.
citation: Husted H, Lunn TH, Troelsen A, Gaarn-Larsen L, Kristensen BB, Kehlet H. Why still in hospital after fast-track hip and knee arthroplasty? Acta Orthop. 2011 Dec;82(6):679-84. doi: 10.3109/17453674.2011.636682. Epub 2011 Nov 9.
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. doi: 10.2106/JBJS.F.00222.
citation: Patel A, Pavlou G, Mujica-Mota RE, Toms AD. The epidemiology of revision total knee and hip arthroplasty in England and Wales: a comparative analysis with projections for the United States. A study using the National Joint Registry dataset. Bone Joint J. 2015 Aug;97-B(8):1076-81. doi: 10.1302/0301-620X.97B8.35170.
citation: Stelzer W, Aiglesberger M, Stelzer D, Stelzer V. Use of cooled radiofrequency lateral branch neurotomy for the treatment of sacroiliac joint-mediated low back pain: a large case series. Pain Med. 2013 Jan;14(1):29-35. doi: 10.1111/pme.12014. Epub 2012 Dec 28.