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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis, Knee
• Intervention / Treatment: Procedure: Total knee replacement

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. 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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Fondren Orthopedic Group, L.L.P.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Fondren Orthopedic Group L.L.P.
• Collaborators: InGeneron, Inc.
• Investigators: Principal Investigator: Gregory W Stocks, MD, Fondren Orthopedic Group L.L.P.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2017
• Primary Completion (Actual): December 1, 2020
• Study Completion (Actual): March 1, 2021

Study Registration Dates

• First Submitted: September 30, 2014
• First Submitted That Met QC Criteria: October 8, 2014
• First Posted (Estimate): October 13, 2014

Study Record Updates

• Last Update Posted (Actual): June 7, 2022
• Last Update Submitted That Met QC Criteria: June 3, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: knee; joint replacement; total knee
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: FOG-TOH175

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No