Neuralgia, Osteoarthritis of the Knee
Conditions
Keywords
Total Knee Arthroplasty
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.
Interventions
PROCEDURETotal knee arthroplasty with Saphenous nerve burial
PROCEDUREStandard total knee arthroplasty
Sponsors
Medstar Health Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of neuralgia | 2 years | Measured by DN4 validated scoring tool |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Oxford Knee Score | 2 years | — |
| Kneeling weight | 2 years | Ability to kneel with body weight on affected knee |
Countries
United States
Outcome results
None listed