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Nerve Burial for Preventing Neuralgia After Total Knee Arthroplasty

Primary Purpose

Neuralgia, Osteoarthritis of the Knee

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Total knee arthroplasty with Saphenous nerve burial

Standard total knee arthroplasty

About this trial

This is an interventional prevention trial for Neuralgia focused on measuring Total Knee Arthroplasty

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Medstar Union Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control

Intervention

Arm Description

Standard total knee arthroplasty performed through medial parapatellar approach

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

Outcomes

Primary Outcome Measures

Incidence of neuralgia

Measured by DN4 validated scoring tool

Secondary Outcome Measures

Oxford Knee Score

Kneeling weight

Ability to kneel with body weight on affected knee

Full Information

NCT ID

NCT02885467

First Posted

August 26, 2016

Last Updated

May 17, 2018

Sponsor

Medstar Health Research Institute

1. Study Identification

Unique Protocol Identification Number

NCT02885467

Brief Title

Nerve Burial for Preventing Neuralgia After Total Knee Arthroplasty

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2018

Overall Recruitment Status

Terminated

Why Stopped

Terminated by IRB

Study Start Date

August 2013 (undefined)

Primary Completion Date

May 2018 (Actual)

Study Completion Date

May 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Medstar Health Research Institute

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neuralgia, Osteoarthritis of the Knee

Keywords

Total Knee Arthroplasty

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

58 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Control

Arm Type

Active Comparator

Arm Description

Standard total knee arthroplasty performed through medial parapatellar approach

Arm Title

Intervention

Arm Type

Experimental

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Total knee arthroplasty with Saphenous nerve burial

Intervention Type

Procedure

Intervention Name(s)

Standard total knee arthroplasty

Primary Outcome Measure Information:

Title

Incidence of neuralgia

Description

Measured by DN4 validated scoring tool

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Oxford Knee Score

Time Frame

2 years

Title

Kneeling weight

Description

Ability to kneel with body weight on affected knee

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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)

Facility Information:

Facility Name

Medstar Union Memorial Hospital

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21218

Country

United States

12. IPD Sharing Statement

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Nerve Burial for Preventing Neuralgia After Total Knee Arthroplasty

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