A Study to Evaluate Preventative Saphenous Nerve Neurectomy in Primary Total Knee Arthroplasty

Overview

  • Study type

    Interventional
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Jacksonville, Florida: 19-000527
    Sponsor Protocol Number: 19-000527

About this study

The purpose of this study is to evaluate the incidence of chronic knee pain at 6 months following primary total knee arthroplasty. Secondary outcomes include incidence of knee numbness, postoperative sensory loss or change at the knee, range of motion (ROM), resting pain with Visual Analog Scale (VAS), Knee Injury and Osteoarthritis Outcome Score (KOOS), quality of life measurement assessed by SF-36.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:

  • Primary unilateral total knee arthroplasty (TKA)  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. 

 

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Glenn Shi, M.D.

Open for enrollment

Contact information:

Glenn Shi M.D.

(904)953-2496

Shi.Glenn@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20456575

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