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OpenTrials
Active, Not Recruiting

NCT Number: NCT04028947

Prophylactic Infrapatellar Saphenous Neurectomy in Primary Total Knee Arthroplasty

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prophylactic Infrapatellar Saphenous Neurectomy in Primary Total Knee Arthroplasty

Procedure

Prophylactic infrapatellar saphenous nerve neurectomy will be performed at the same time as the TKA.

Primary outcomes

  1. Pain after surgery

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Jul 23, 2019
Registry last updated
Jan 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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