N/A
N=70
Does Radiofrequency Ablation of the Articular Nerves of the Knee Prior to Total Knee Replacement Improve Pain Outcomes
Arthroplasty, Replacement, Knee
Bottom Line
View on ClinicalTrials.gov: NCT02746874 ↗Enrolled (actual)
70
Serious AEs
0.0%
Results posted
Feb 2021
Primary outcome: Primary: Opioid Consumption After Surgery — 192; 144 Morphine Equivalents (ME) — p=.978
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Radiofrequency Ablation (RFA) (Procedure); Simulated Radiofrequency Ablation (RFA) (Procedure)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- All
- Sponsor
- Northwestern University
- Primary completion
- Jun 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Opioid Consumption After Surgery |
192; 144 | .978 |
| SECONDARY Oral Morphine Equivalent Milligrams at Baseline. |
0; 0 | — |
| SECONDARY Oral Morphine Equivalents at Baseline Compared to 48 Hours Post-operative. |
-187; -191 | .978 |
| SECONDARY Medication Quantification Scale III (MQSIII) Score 48 Hours Post-operative. |
33; 35 | .371 |
| SECONDARY Number of Stairs Climbed on Post-operative Day 2. |
7; 8 | .325 |
| SECONDARY Distance Walked on Post-operative Day 2. |
216; 232 | .466 |
| SECONDARY Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score 6 Months Post Operative |
8; 9 | .368 |
Summary
More than 300,000 total knee joint replacement surgeries are performed per year in the United States and safe, effective management of post-operative pain in these patients, often elderly, deconditioned, obese, or with co-morbid diseases like sleep apnea, can be challenging and often require a multidisciplinary, multimodal approach. Opiates have been a mainstay of treatment in the post-operative period with varying degrees of success and complications. Inadequately controlled postoperative pain is not uncommon. Poorly controlled pain inhibits early mobilization and hinders post-operative physical therapy.
A new paradigm for treating post-operative pain following total knee replacement may be the use of cooled radiofrequency ablation (C-RFA) of the articular sensory nerve supply of the knee capsule prior to surgery, to desensitize the knee by blocking sensory afferents to the anterior capsule and thereby decrease post-operative pain. There are several publications that have demonstrated the use of RFA in patients with chronic knee pain from osteoarthritis however the use of RFA in the preoperative management of pain in patients undergoing total knee joint replacement has not been investigated.
The aim of this study is to determine if patients undergoing unilateral total knee replacement obtain any post-operative pain relieving benefits from C-RFA of the articular sensory nerve supply when performed prior to surgery, as compared to sham controls who receive only local anesthetic injections of these same nerves without the benefit of ablation treatment.
Eligibility Criteria
Inclusion Criteria
- osteoarthritis of the knee scheduled to undergo their first unilateral knee joint replacement
- willingness to undergo fluoroscopy-guided C-RFA or sham treatment
Exclusion Criteria
- pregnancy,
- severe cardiac/pulmonary compromise,
- acute illness/infection,
- coagulopathy
- bleeding disorder,
- allergic reactions,
- contraindications to a local anesthetic
Data sourced from ClinicalTrials.gov (NCT02746874). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.