Status:
COMPLETED
Thigh Pain After Total Knee Arthroplasty (TKA)
Lead Sponsor:
Fondren Orthopedic Group L.L.P.
Collaborating Sponsors:
InGeneron, Inc.
Conditions:
Osteoarthritis, Knee
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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...
Detailed Description
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....
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2021
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT02262988
Start Date
September 1 2017
End Date
March 1 2021
Last Update
June 7 2022
Active Locations (1)
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1
Fondren Orthopedic Group, L.L.P.
Houston, Texas, United States, 77030