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Thigh Pain After Total Knee Arthroplasty (TKA)

Primary Purpose

Osteoarthritis, Knee

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Total knee replacement
Sponsored by
Fondren Orthopedic Group L.L.P.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring knee, joint replacement, total knee

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fondren Orthopedic Group, L.L.P.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Tourniquet used with intramedullary rod

No tourniquet with intramedullary rod

Tourniquet without intramedullary rod

No tourniquet without intramedullary rod

Arm Description

Patients will undergo a total knee replacement with a tourniquet and intramedullary rod.

Patients will undergo a total knee replacement without a tourniquet and with an intramedullary rod.

Patients will undergo a total knee replacement with a tourniquet and without an intramedullary rod.

Patients will undergo a total knee replacement without a tourniquet nor an intramedullary rod.

Outcomes

Primary Outcome Measures

Knee Injury and Osteoarthritis Outcomes Survey (KOOS)
Survey

Secondary Outcome Measures

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

Full Information

First Posted
September 30, 2014
Last Updated
June 3, 2022
Sponsor
Fondren Orthopedic Group L.L.P.
Collaborators
InGeneron, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02262988
Brief Title
Thigh Pain After Total Knee Arthroplasty (TKA)
Official Title
Thigh Pain After Total Knee Arthroplasty (TKA)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
December 1, 2020 (Actual)
Study Completion Date
March 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondren Orthopedic Group L.L.P.
Collaborators
InGeneron, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 techniques are accepted and produce good clinical results.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
Keywords
knee, joint replacement, total knee

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tourniquet used with intramedullary rod
Arm Type
Experimental
Arm Description
Patients will undergo a total knee replacement with a tourniquet and intramedullary rod.
Arm Title
No tourniquet with intramedullary rod
Arm Type
Experimental
Arm Description
Patients will undergo a total knee replacement without a tourniquet and with an intramedullary rod.
Arm Title
Tourniquet without intramedullary rod
Arm Type
Experimental
Arm Description
Patients will undergo a total knee replacement with a tourniquet and without an intramedullary rod.
Arm Title
No tourniquet without intramedullary rod
Arm Type
Experimental
Arm Description
Patients will undergo a total knee replacement without a tourniquet nor an intramedullary rod.
Intervention Type
Procedure
Intervention Name(s)
Total knee replacement
Intervention Description
Total knee replacement (TKA)
Primary Outcome Measure Information:
Title
Knee Injury and Osteoarthritis Outcomes Survey (KOOS)
Description
Survey
Time Frame
up to 3 months
Secondary Outcome Measure Information:
Title
Pain Scores on Numerical Rating Scale
Description
Pain scale from 0-10 with 0 representing no pain and 10 representing maximum pain.
Time Frame
up to 3 months
Title
Knee swelling
Description
Physician evaluation
Time Frame
up to 3 months
Title
Knee Range of Motion
Description
Goniometer measurement
Time Frame
up to 3 months
Title
Number of Patients with Adverse Events as a Measure of Safety
Description
Adverse events
Time Frame
up to 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregory W Stocks, MD
Organizational Affiliation
Fondren Orthopedic Group L.L.P.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fondren Orthopedic Group, L.L.P.
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

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Thigh Pain After Total Knee Arthroplasty (TKA)

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