Thigh Pain After Total Knee Arthroplasty (TKA)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Thigh Pain After Total Knee Arthroplasty (TKA)

Conditions
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Osteoarthritis, Knee

Intervention / Treatment
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* Procedure: Total knee replacement


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tourniquet used with intramedullary rod<br>Patients will undergo a total knee replacement with a tourniquet and intramedullary rod. | Procedure: Total knee replacement<br>* Total knee replacement (TKA)<br>|
| Experimental: No tourniquet with intramedullary rod<br>Patients will undergo a total knee replacement without a tourniquet and with an intramedullary rod. | Procedure: Total knee replacement<br>* Total knee replacement (TKA)<br>|
| Experimental: Tourniquet without intramedullary rod<br>Patients will undergo a total knee replacement with a tourniquet and without an intramedullary rod. | Procedure: Total knee replacement<br>* Total knee replacement (TKA)<br>|
| Experimental: No tourniquet without intramedullary rod<br>Patients will undergo a total knee replacement without a tourniquet nor an intramedullary rod. | Procedure: Total knee replacement<br>* Total knee replacement (TKA)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee Injury and Osteoarthritis Outcomes Survey (KOOS) | Survey | up to 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Scores on Numerical Rating Scale | Pain scale from 0-10 with 0 representing no pain and 10 representing maximum pain. | up to 3 months | 
| Knee swelling | Physician evaluation | up to 3 months | 
| Knee Range of Motion | Goniometer measurement | up to 3 months | 
| Number of Patients with Adverse Events as a Measure of Safety | Adverse events | up to 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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knee, joint replacement, total knee