Clinical trial NCT02885467: Nerve Burial for Preventing Neuralgia After Total Knee Arthroplasty
Official title: Saphenous Nerve Brach Burial for Preventing Neuralgia After Total Knee Arthroplasty: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Neuralgia
Osteoarthritis of the Knee
Keywords: Total Knee Arthroplasty
Lead sponsor: Medstar Health Research Institute
Sponsor class: OTHER
First posted: 2016-08-31
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a randomized study investigating whether identification, ligation, and burial of superficial branches of the saphenous nerve crossing the surgical field during total knee arthroplasty reduces the rate of post-operative anterior knee pain and neuralgia compared to standard total knee arthroplasty.

Detailed description: Anterior knee pain is common after total knee arthroplasty. The incision necessarily travels through the path of a cutaneous nerve - branches of the saphenous nerve. Historically, no effort has been made to separate these branches and bury them away from the surgical scar. It has been noted that some patients develop a painful neuroma, that once resected results in a pain free knee. Investigators are trying to study if identification, ligation, and proper burial of the nerve can prevent the development of neuralgia compared to the typical surgical approach which ignores the nerve branches completely.

Eligibility criteria: Inclusion Criteria:

* Must have symptomatic knee osteoarthritis under consideration for total knee arthroplasty
* Must be willing to undergo randomization

Exclusion Criteria:

* Age \<18 or \>80 years
* Known pre-operative diagnosis of neuralgia, complex regional pain syndrome, or neuropathy, about the operative lower extremity
* Known pre-operative psychiatric disorder requiring medication
* Previous surgery about the operative knee
* BMI \> 40 kg/m2 (potential increased risk of soft tissue dissection through adipose)
* Ongoing pre-operative narcotic use in excess of 20 mg morphine equivalents per day for at least one month or pre-operative intravenous drug use (increased potential for complex regional pain syndrome and neuralgia, increased likelihood to require greater post-operative analgesia)
* Ongoing pre-operative use of neuropathic pain medications (gabapentin, pregabalin, amitriptyline, etc.)
* Medical comorbidities (American Society of Anesthesiologists grade \> 3 or deemed unfit by consulting internist) precluding elective TKA
* Significant language barrier (reading comprehension less than 8th grade reading level) or mental condition precluding accurate self-assessment of knee pain or function.
* Severe medication allergies to permissible post-operative analgesics (acetaminophen, tramadol, oxycodone, oxycontin, dilaudid)

Primary outcomes:
measure: Incidence of neuralgia
timeFrame: 2 years
Secondary outcomes:
measure: Oxford Knee Score
timeFrame: 2 years
measure: Kneeling weight
timeFrame: 2 years
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Medstar Union Memorial Hospital
state: Maryland
Study officials:
References: