Nerve Burial for Preventing Neuralgia After Total Knee Arthroplasty

Not Applicable

Terminated

• Conditions: Neuralgia; Osteoarthritis of the Knee

• Registration Number: NCT02885467
• Lead Sponsor: Medstar Health Research Institute

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.

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2016-08-26
• Study First Submitted QC: 2016-08-30
• Study First Posted: 2016-08-31
• Status Verified: 2018-05
• Primary Completion: 2018-05
• Study Completion: 2018-05
• Last Update Submitted: 2018-05-17
• Last Update Posted: 2018-05-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 58

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Incidence of neuralgia	2 years	Measured by DN4 validated scoring tool

Secondary Outcome Measures

Name	Time	Method
Oxford Knee Score	2 years
Kneeling weight	2 years	Ability to kneel with body weight on affected knee

Trial Locations

Locations (1)

Medstar Union Memorial Hospital; 🇺🇸 Baltimore, Maryland, United States