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

This study has been completed.
Sponsor:
Collaborator:
St. Joseph's Health Care London
Information provided by (Responsible Party):
New Lexington Clinic
ClinicalTrials.gov Identifier:
NCT00492973
First received: June 25, 2007
Last updated: October 29, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention
Osteoarthritis
Post-traumatic; Arthrosis
Drug: methylprednisolone acetate
Drug: active comparator

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Peri-articular Injections Containing a Corticosteroid During Total Knee Arthroplasty

Resource links provided by NLM:


Further study details as provided by New Lexington Clinic:

Primary Outcome Measures:
  • Length of Hospital Stay [ Time Frame: days after surgery ] [ Designated as safety issue: No ]
  • Knee Range of Motion [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Knee Society Scores [ Time Frame: 3 months postoperative ] [ Designated as safety issue: No ]
    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.

  • Amount of Pain Medication Taken Per Day [ Time Frame: Average of 3 days after surgery ] [ Designated as safety issue: Yes ]
  • Patient Satisfaction [ Time Frame: 6 weeks, 3 months, and 1 year postoperative ] [ Designated as safety issue: No ]
  • Complications, Such as Infections, Hospital Readmissions, Manipulations Under Anesthesia, Etc. [ Time Frame: any point during the first postoperative year ] [ Designated as safety issue: Yes ]

Enrollment: 101
Study Start Date: March 2006
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • bupivacaine HCl
  • morphine
  • epinephrine
  • clonidine
  • cefuroxime
  • normal saline
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
Other Name: methylprednisolone acetate

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.

  Eligibility

Ages Eligible for Study:   18 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00492973

Locations
United States, Kentucky
Lexington Clinic Sports Medicine Center
Lexington, Kentucky, United States, 40504
Sponsors and Collaborators
New Lexington Clinic
St. Joseph's Health Care London
Investigators
Principal Investigator: Christian P Christensen, MD New Lexington Clinic
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: New Lexington Clinic
ClinicalTrials.gov Identifier: NCT00492973     History of Changes
Other Study ID Numbers: LCO.2006.2
Study First Received: June 25, 2007
Results First Received: October 18, 2012
Last Updated: October 29, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by New Lexington Clinic:
arthroplasty
replacement
knee

Additional relevant MeSH terms:
Joint Diseases
Osteoarthritis
Musculoskeletal Diseases
Arthritis
Rheumatic Diseases
Epinephrine
Clonidine
Epinephryl borate
Methylprednisolone
Bupivacaine
Morphine
Methylprednisolone Hemisuccinate
Cefuroxime
Cefuroxime axetil
Methylprednisolone acetate
Prednisolone acetate
Prednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents

ClinicalTrials.gov processed this record on July 22, 2014