Nerve Burial for Preventing Neuralgia After Total Knee Arthroplasty

NCT ID: NCT02885467

Last Updated: 2018-05-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2018-05-31

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.

Conditions

Neuralgia; Osteoarthritis of the Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Control

Standard total knee arthroplasty performed through medial parapatellar approach

Group Type: ACTIVE_COMPARATOR

Standard total knee arthroplasty

Intervention Type: PROCEDURE

Intervention

Total knee arthroplasty performed through medial parapatellar approach with identification, ligation, and burial of saphenous nerve branches

Group Type: EXPERIMENTAL

Total knee arthroplasty with Saphenous nerve burial

Intervention Type: PROCEDURE

Interventions

Total knee arthroplasty with Saphenous nerve burial

Intervention Type: PROCEDURE

Standard total knee arthroplasty

Intervention Type: PROCEDURE

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medstar Health Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Medstar Union Memorial Hospital

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

IRB 2013-281

Identifier Type: -

Identifier Source: org_study_id