Osteoarthritis of the Knee
Conditions
Keywords
Unilateral Knee Arthroplasty, Radiofrequency Ablation, Genicular, RFA, C-RFA, t-RFA, total knee replacement
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.
Interventions
PROCEDUREt-RFA
standard thermal genicular radiofrequency ablation
PROCEDUREC-RFA
Cooled radiofrequency ablation
PROCEDUREControl
Simulated radiofrequency ablation for placebo controlled group
Sponsors
Halyard Health
Lyman Medical Research Foundation, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
Genicular radiofrequency ablation performed prior to total knee arthroplasty for pain management
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative analgesic consumption | 0 - 3 weeks postoperatively | Measure opioid consumption for the three study arms |
| Hospital Length of Stay (LOS) | 0-5 days postoperatively | Measure hospital length of stay for the three study arms |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Score | before treatment arm procedures to 12 months after unilateral knee arthroplasty | assess patient pain score diaries after total knee replacement for the three treatment arms |
Countries
United States
Outcome results
None listed