Nerve Burial for Preventing Neuralgia After Total Knee Arthroplasty

Study Overview
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Brief Summary
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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
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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.

Official Title
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Saphenous Nerve Brach Burial for Preventing Neuralgia After Total Knee Arthroplasty: A Randomized Controlled Trial

Conditions
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Neuralgia, Osteoarthritis of the Knee

Intervention / Treatment
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* Procedure: Total knee arthroplasty with Saphenous nerve burial
* Procedure: Standard total knee arthroplasty


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>Standard total knee arthroplasty performed through medial parapatellar approach | Procedure: Standard total knee arthroplasty<br> <br> |
| Experimental: Intervention<br>Total knee arthroplasty performed through medial parapatellar approach with identification, ligation, and burial of saphenous nerve branches | Procedure: Total knee arthroplasty with Saphenous nerve burial<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of neuralgia | Measured by DN4 validated scoring tool | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxford Knee Score |  | 2 years | 
| Kneeling weight | Ability to kneel with body weight on affected knee | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Total Knee Arthroplasty