Thigh Pain After Total Knee Arthroplasty (TKA)

Osteoarthritis, Knee Clinical Trial

Official title:

Thigh Pain After Total Knee Arthroplasty (TKA)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02262988
• Other study ID #: FOG-TOH175
• Status: Completed
• Phase: N/A
• Start date: September 1, 2017
• Est. completion date: March 1, 2021

Study information

• Verified date: May 2022
• Source: Fondren Orthopedic Group L.L.P.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 techniques are accepted and produce good clinical results.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 1, 2021
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis, Knee

Intervention

Procedure:
• Total knee replacement
Total knee replacement (TKA)

Locations

Country	Name	City	State
United States	Fondren Orthopedic Group, L.L.P.	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Fondren Orthopedic Group L.L.P.	InGeneron, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Knee Injury and Osteoarthritis Outcomes Survey (KOOS)	Survey	up to 3 months
Secondary	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
Secondary	Knee swelling	Physician evaluation	up to 3 months
Secondary	Knee Range of Motion	Goniometer measurement	up to 3 months
Secondary	Number of Patients with Adverse Events as a Measure of Safety	Adverse events	up to 3 months