Prophylactic Infrapatellar Saphenous Neurectomy in Primary Total Knee Arthroplasty

Prophylactic Infrapatellar Saphenous Neurectomy in Primary Total Knee Arthroplasty: A Double-Blind Randomized Controlled Trial

Researchers are trying to determine if knee pain can be reduced by proactively protecting the free end of the saphenous nerve versus leaving it in the standard position during total knee arthroplasty.

Study Overview

• Status: Active, not recruiting
• Conditions: Knee Pain Chronic
• Intervention / Treatment: Procedure: Prophylactic Infrapatellar Saphenous Neurectomy in Primary Total Knee Arthroplasty

Detailed Description

Subjects scheduled for total knee arthroplasty will be randomized to two arms. One arm will have the standard saphenous nerve neurectomy during their surgery. The other arm will have the same neurectomy procedure with the free end of the nerve tucked into soft tissue to protect the nerve ending.

• Study Type: Interventional
• Enrollment (Actual): 178
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic in Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Primary unilateral total knee arthroplasty candidate

Exclusion Criteria:

• Body Mass Index (BMI) >40
• Inflammatory arthritis
• Unable to follow up visits (long distance from Mayo Clinic)
• Poor compliance risk
• Health condition deemed by physician to preclude patient's ability to participate in the trial

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
No Intervention: Standard TKA; Subjects will have the standard procedure.
Active Comparator: TKA with Neurectomy; Subjects will the nerve excised and protected with soft tissue.	Procedure: Prophylactic Infrapatellar Saphenous Neurectomy in Primary Total Knee Arthroplasty; Prophylactic infrapatellar saphenous nerve neurectomy will be performed at the same time as the TKA.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain after surgery	Self-reported pain using Visual Analog Scale which is scored using a horizontal scale from 0-10cm with 10 being the worst pain.	6 months

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Glenn G Shi, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): January 28, 2020
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: March 27, 2019
• First Submitted That Met QC Criteria: July 22, 2019
• First Posted (Actual): July 23, 2019

Study Record Updates

• Last Update Posted (Actual): March 25, 2024
• Last Update Submitted That Met QC Criteria: March 22, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 19-000527

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No