Nerve Burial for Preventing Neuralgia After Total Knee Arthroplasty

NCT02885467 | Terminated

• 1 other identifier: IRB 2013-281
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuralgia; Osteoarthritis of the Knee

Keywords

Total Knee Arthroplasty

Outcome Measures

Primary Outcomes (1)

• Incidence of neuralgia

  Measured by DN4 validated scoring tool

  2 years

Secondary Outcomes (2)

• Oxford Knee Score

  2 years

• Kneeling weight

  2 years

Study Arms (2)

Control

ACTIVE COMPARATOR

Standard total knee arthroplasty performed through medial parapatellar approach

Procedure: Standard total knee arthroplasty

Intervention

EXPERIMENTAL

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

Interventions

Total knee arthroplasty with Saphenous nerve burial PROCEDURE

Intervention

Standard total knee arthroplasty PROCEDURE

Control

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must have symptomatic knee osteoarthritis under consideration for total knee arthroplasty
• Must be willing to undergo randomization

You may not qualify if:

• 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)

Sponsors & Collaborators

• Medstar Health Research Institute: lead

Study Sites (1)

Medstar Union Memorial Hospital

Baltimore, Maryland, 21218, United States

Location

MeSH Terms

Conditions

Neuralgia; Osteoarthritis, Knee

Interventions

Arthroplasty, Replacement, Knee

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2016
• First Posted: August 31, 2016
• Study Start: August 1, 2013
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: May 21, 2018

Record last verified: 2018-05

Locations

US (1)