Nerve Burial for Preventing Neuralgia After Total Knee Arthroplasty

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

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.

Study Overview

• Status: Terminated
• Conditions: Neuralgia; Osteoarthritis of the Knee
• Intervention / Treatment: Procedure: Standard total knee arthroplasty; Procedure: Total knee arthroplasty with Saphenous nerve burial

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 Type: Interventional
• Enrollment (Actual): 58
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21218
      • MedStar Union Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control; Standard total knee arthroplasty performed through medial parapatellar approach	Procedure: Standard total knee arthroplasty
Experimental: Intervention; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Medstar Health Research Institute

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Actual): May 1, 2018
• Study Completion (Actual): May 1, 2018

Study Registration Dates

• First Submitted: August 26, 2016
• First Submitted That Met QC Criteria: August 30, 2016
• First Posted (Estimate): August 31, 2016

Study Record Updates

• Last Update Posted (Actual): May 21, 2018
• Last Update Submitted That Met QC Criteria: May 17, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: Total Knee Arthroplasty
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Neuromuscular Diseases; Peripheral Nervous System Diseases; Osteoarthritis; Osteoarthritis, Knee; Neuralgia
• Other Study ID Numbers: IRB 2013-281