Prophylactic Infrapatellar Saphenous Neurectomy in Primary Total Knee Arthroplasty

Not Applicable

Active, not recruiting

• Conditions: Knee Pain Chronic
• Interventions: Procedure: Prophylactic Infrapatellar Saphenous Neurectomy in Primary Total Knee Arthroplasty

• Registration Number: NCT04028947
• Lead Sponsor: Mayo Clinic

Brief Summary

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.

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 Timeline

• Study First Submitted: 2019-03-27
• Study First Submitted QC: 2019-07-22
• Study First Posted: 2019-07-23
• Study Start: 2020-01-28
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-07
• Last Update Posted: 2025-03-10
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 178

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TKA with Neurectomy	Prophylactic Infrapatellar Saphenous Neurectomy in Primary Total Knee Arthroplasty	Subjects will the nerve excised and protected with soft tissue.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Mayo Clinic in Florida; 🇺🇸 Jacksonville, Florida, United States