Prophylactic Infrapatellar Saphenous Neurectomy in Primary Total Knee Arthroplasty

NCT ID: NCT04028947

Last Updated: 2026-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

178 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-28

Study Completion Date

2026-12-31

Brief Summary

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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

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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.

Conditions

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Knee Pain Chronic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Standard TKA

Subjects will have the standard procedure.

Group Type NO_INTERVENTION

No interventions assigned to this group

TKA with Neurectomy

Subjects will the nerve excised and protected with soft tissue.

Group Type ACTIVE_COMPARATOR

Prophylactic Infrapatellar Saphenous Neurectomy in Primary Total Knee Arthroplasty

Intervention Type PROCEDURE

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

Interventions

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Prophylactic Infrapatellar Saphenous Neurectomy in Primary Total Knee Arthroplasty

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Glenn G. Shi, M.D.

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Glenn G Shi, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Florida

Jacksonville, Florida, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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19-000527

Identifier Type: -

Identifier Source: org_study_id

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