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Prophylactic Infrapatellar Saphenous Neurectomy in Primary Total Knee Arthroplasty

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

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04028947
Enrollment
178
Registered
2019-07-23
Start date
2020-01-28
Completion date
2026-12-31
Last updated
2026-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Pain Chronic

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.

Interventions

PROCEDUREProphylactic Infrapatellar Saphenous Neurectomy in Primary Total Knee Arthroplasty

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

Sponsors

Mayo Clinic
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Pain after surgery6 monthsSelf-reported pain using Visual Analog Scale which is scored using a horizontal scale from 0-10cm with 10 being the worst pain.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026