NCT04028947

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
178

participants targeted

Target at P75+ for not_applicable

Timeline
7mo left

Started Jan 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress92%
Jan 2020Dec 2026

First Submitted

Initial submission to the registry

March 27, 2019

Completed
4 months until next milestone

First Posted

Study publicly available on registry

July 23, 2019

Completed
6 months until next milestone

Study Start

First participant enrolled

January 28, 2020

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

January 14, 2026

Status Verified

January 1, 2026

Enrollment Period

6.8 years

First QC Date

March 27, 2019

Last Update Submit

January 12, 2026

Conditions

Knee Pain Chronic

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Standard TKA

NO INTERVENTION

Subjects will have the standard procedure.

TKA with Neurectomy

ACTIVE COMPARATOR

Subjects will the nerve excised and protected with soft tissue.

Procedure: Prophylactic Infrapatellar Saphenous Neurectomy in Primary Total Knee Arthroplasty

Interventions

Prophylactic Infrapatellar Saphenous Neurectomy in Primary Total Knee ArthroplastyPROCEDURE

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

TKA with Neurectomy

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Primary unilateral total knee arthroplasty candidate

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Location

Related Links

Study Officials

  • Glenn G Shi, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 27, 2019

First Posted

July 23, 2019

Study Start

January 28, 2020

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

January 14, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)