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NCT04028947 Clinical Trial

Prophylactic Infrapatellar Saphenous Neurectomy in Primary Total Knee Arthroplasty

Knee Pain Chronic Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04028947
Other study ID # 19-000527
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date January 28, 2020
Est. completion date December 2024

Study information
Verified date March 2024
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 178
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Procedure:
• Prophylactic Infrapatellar Saphenous Neurectomy in Primary Total Knee Arthroplasty
Prophylactic infrapatellar saphenous nerve neurectomy will be performed at the same time as the TKA.

Locations
Country Name City State
United States Mayo Clinic in Florida Jacksonville Florida

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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