Do Corticosteroid Injections During Total Knee Replacement Improve Early Clinical Results?

October 29, 2013 updated by: New Lexington Clinic

Peri-articular Injections Containing a Corticosteroid During Total Knee Arthroplasty

Prior to surgery, a pharmacist will randomly assign participating patients to one of two groups. One group will get an injection in the knee during surgery that contains medications to limit pain and an antibiotic. A second group will get an injection in the knee during surgery that contains the same pain medications and antibiotic along with a corticosteroid to control inflammation. Corticosteroids are anti-inflammatory medications, not to be confused with muscle-building anabolic steroids you may have heard about in the news. Each patient will have an equal chance of being in either of the two groups. This study will test the safety and efficacy of methylprednisolone acetate in the treatment of pain and inflammation following total knee replacement.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Information collected during your office visits:

The patient will be asked for a brief medical history so that we may determine if the patient can participate in the study. A member of our research team will ask the patient a series of questions about his/her knee. The patient will be asked to answer this series of questions a total of 4 times over the course of 1 year. Also, we will record how well the patient can bend and straighten your knee at these 4 office visits. We will have the patient rate the pain in his/her knee and ask the patient if he/she is satisfied with the surgery. If the patients have any complications, those will also be recorded. The patient will also have X-rays taken of the knee at the postoperative follow-up visits. This is the normal routine following total knee replacement. The X-rays will be read by the surgeon to help determine the success of the surgery.

Injection during total knee replacement surgery:

All patients will receive an injection containing bupivicaine HCl, morphine, epinephrine, clonidine, cefuroxime, and normal saline that will be placed directly into the knee during surgery. In addition, approximately half of the patients in the study will also receive methylprednisolone acetate as part of the injection.

Information being collected during your hospital stay:

During the hospital stay, information will be gathered for this study. A physical therapist will measure how well the patient can bend and straighten the knee. The amount of pain medication that was taken at the hospital will be recorded, and the number of days spent in the hospital will also be recorded.

Study Type

Interventional

Enrollment (Actual)

101

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Lexington, Kentucky, United States, 40504
        • Lexington Clinic Sports Medicine Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Between ages of 18 and 95
  • Has elected to undergo total knee replacement

Exclusion Criteria:

  • Allergy to any of the medications used in the protocol
  • History of kidney disease
  • Rheumatoid arthritis
  • Any systemic conditions associated with chronic pain
  • History of deep knee sepsis in the affected extremity
  • Unable to understand the questions used to obtain the Knee Society Score
  • Minors and prisoners will be excluded from the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control
Patients in the active comparator group will receive intraoperative injections containing bupivacaine HCl, morphine, epinephrine, clonidine, cefuroxime, and normal saline, as per the surgeon's standard of care.
Drug: active comparator
bupivacaine HCl 80 mg, morphine 4 mg, epinephrine 300 micrograms, clonidine 100 micrograms, cefuroxime 750 mg, and normal saline
Other Names:
  • normal saline
  • morphine
  • epinephrine
  • clonidine
  • bupivacaine HCl
  • cefuroxime
Experimental: Corticosteroid
Patients in the Corticosteroid group will have the same medications as the Control Group with the addition of a corticosteroid (methylprednisolone acetate)
Drug: methylprednisolone acetate
Same medications and doses as the active comparator, but with the addition of 40 mg of methylprednisolone acetate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of Hospital Stay
Time Frame: days after surgery
days after surgery
Knee Range of Motion
Time Frame: 3 months
3 months
Knee Society Scores
Time Frame: 3 months postoperative
The Knee Society Score is on a scale of 0 to 100, with 0 being the worst possible score, and 100 being the best possible score. The Knee Society Score takes into account subjective patient reports of pain and functional ability as well as clinical measures of passive knee range of motion.
3 months postoperative
Amount of Pain Medication Taken Per Day
Time Frame: Average of 3 days after surgery
Average of 3 days after surgery
Patient Satisfaction
Time Frame: 6 weeks, 3 months, and 1 year postoperative
6 weeks, 3 months, and 1 year postoperative
Complications, Such as Infections, Hospital Readmissions, Manipulations Under Anesthesia, Etc.
Time Frame: any point during the first postoperative year
any point during the first postoperative year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

New Lexington Clinic

Collaborators

St. Joseph's Health Care London

Investigators

  • Principal Investigator: Christian P Christensen, MD, New Lexington Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Primary Completion (Actual)

February 1, 2008

Study Completion (Actual)

February 1, 2008

Study Registration Dates

First Submitted

June 25, 2007

First Submitted That Met QC Criteria

June 25, 2007

First Posted (Estimate)

June 27, 2007

Study Record Updates

Last Update Posted (Estimate)

December 19, 2013

Last Update Submitted That Met QC Criteria

October 29, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LCO.2006.2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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