Does Radiofrequency Ablation of the Articular Nerves of the Knee Prior to Total Knee Replacement Improve Pain Outcomes
Status: | Active, not recruiting |
---|---|
Conditions: | Orthopedic |
Therapuetic Areas: | Orthopedics / Podiatry |
Healthy: | No |
Age Range: | 30 - 80 |
Updated: | 9/8/2018 |
Start Date: | December 2015 |
End Date: | November 15, 2018 |
Does Radiofrequency Ablation of the Articular Nerves of the Knee Prior to Total Knee Replacement Improve Pain Outcomes? A Prospective Randomized Sham-Control Trial With 6 Month Follow Up
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.
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.
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
We found this trial at
1
site
675 North Saint Clair Street
Chicago, Illinois 60605
Chicago, Illinois 60605
Phone: 312-695-7771
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