Nerve Burial for Preventing Neuralgia After Total Knee Arthroplasty

Osteoarthritis of the Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02885467
• Other study ID #: IRB 2013-281
• Status: Terminated
• Phase: N/A
• Start date: August 2013
• Est. completion date: May 2018

Study information

• Verified date: May 2018
• Source: Medstar Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 58
• Est. completion date: May 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Neuralgia
• Osteoarthritis
• Osteoarthritis of the Knee
• Osteoarthritis, Knee

Intervention

Procedure:
• Total knee arthroplasty with Saphenous nerve burial

• Standard total knee arthroplasty

Locations

Country	Name	City	State
United States	Medstar Union Memorial Hospital	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Medstar Health Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of neuralgia	Measured by DN4 validated scoring tool	2 years
Secondary	Oxford Knee Score		2 years
Secondary	Kneeling weight	Ability to kneel with body weight on affected knee	2 years