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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00492973
Recruitment Status : Completed
First Posted : June 27, 2007
Results First Posted : December 19, 2013
Last Update Posted : December 19, 2013
St. Joseph's Health Care London
Information provided by (Responsible Party):
New Lexington Clinic

Brief Summary:
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 or disease Intervention/treatment Phase
Osteoarthritis Post-traumatic; Arthrosis Drug: methylprednisolone acetate Drug: active comparator Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 101 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Peri-articular Injections Containing a Corticosteroid During Total Knee Arthroplasty
Study Start Date : March 2006
Actual Primary Completion Date : February 2008
Actual Study Completion Date : February 2008

Resource links provided by the National Library of Medicine

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:
  • 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

Primary Outcome Measures :
  1. Length of Hospital Stay [ Time Frame: days after surgery ]
  2. Knee Range of Motion [ Time Frame: 3 months ]
  3. 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.

  4. Amount of Pain Medication Taken Per Day [ Time Frame: Average of 3 days after surgery ]
  5. Patient Satisfaction [ Time Frame: 6 weeks, 3 months, and 1 year postoperative ]
  6. Complications, Such as Infections, Hospital Readmissions, Manipulations Under Anesthesia, Etc. [ Time Frame: any point during the first postoperative year ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00492973

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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
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Principal Investigator: Christian P Christensen, MD New Lexington Clinic
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: New Lexington Clinic Identifier: NCT00492973    
Other Study ID Numbers: LCO.2006.2
First Posted: June 27, 2007    Key Record Dates
Results First Posted: December 19, 2013
Last Update Posted: December 19, 2013
Last Verified: April 2013
Keywords provided by New Lexington Clinic:
Additional relevant MeSH terms:
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Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Opioid
Anti-Inflammatory Agents
Autonomic Agents
Gastrointestinal Agents