Skip to main content
OpenTrials
Completed

NCT Number: NCT02262988

Thigh Pain After Total Knee Arthroplasty (TKA)

The purpose of this research study is to evaluate the cause of thigh pain after knee replacement. Different surgical techniques will be used to help determine the cause of thigh pain, and all surgical techniques are accepted and produce good clinical results.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fondren Orthopedic Group, L.L.P.

Houston, Texas, 77030, United States

About this study

This research study will be a randomized study in which patients volunteer participate. "Randomized" means the patients who received the new treatment are chosen at random, similar to flipping a coin. Several factors have been identified as possible sources of thigh pain after surgery: use of a tourniquet around the thigh to control bleeding during surgery; use of an intramedullary rod during surgery or quadriceps muscle strain. Participants will be randomized into surgical groups that use/do not use a tourniquet and use/do not use intramedullary rod during surgery. A subset of participants in all surgical groups will have a MRI to look for quadriceps muscle strain.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects undergoing total knee arthroplasty for osteoarthritis
  • Adult patients (age 18 years or older)
  • Written informed consent
  • Ability to speak, read and write English or Spanish

Exclusion criteria

  • Inability to speak, read and write English or Spanish
  • Evidence of malignant disorder/neoplasm in past 60 months
  • Contraindication for removal of infrapatellar fat pad
  • History of smoking and not committed to give up
  • Chronic skin conditions
  • Connective, metabolic or skin disease
  • Evidence of active infection
  • Pregnancy or lactating for female subjects
  • Current corticosteroid use
  • Immunosuppressive medication
  • Renal failure (creatine > 1.8 mg/dL)
  • Hepatic failure (AST, ALT > 2x normal values; bilirubin > 2 mg/dL)
  • Inflammatory joint diseases of the knee that indicate additional, conflating therapies
  • Joint infection within the past 6 months
  • No prisoners or mentally disabled persons
  • No Workers' Compensation cases

Treatment and study plan

Total Knee Replacement

Procedure

Total knee replacement (TKA)

Primary outcomes

  1. Knee Injury and Osteoarthritis Outcomes Survey (KOOS)

    Time frame: up to 3 months

    Survey

Secondary outcomes

  1. Pain Scores on Numerical Rating Scale

    Time frame: up to 3 months

    Pain scale from 0-10 with 0 representing no pain and 10 representing maximum pain.

  2. Knee swelling

    Time frame: up to 3 months

    Physician evaluation

  3. Knee Range of Motion

    Time frame: up to 3 months

    Goniometer measurement

  4. Number of Patients with Adverse Events as a Measure of Safety

    Time frame: up to 3 months

    Adverse events

Sponsors and collaborators

Lead sponsor

Fondren Orthopedic Group L.L.P.

Other

Collaborators

  • InGeneron, Inc.

Registry information

Important dates

Study start
2017
Primary completion
2020
Study completion
2021
First posted
Oct 13, 2014
Registry last updated
Jun 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.