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Completed

NCT Number: NCT00492973

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

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.

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Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Post-traumatic; Arthrosis Rheumatic Diseases

Age range

18 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lexington Clinic Sports Medicine Center

Lexington, Kentucky, 40504, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Methylprednisolone Acetate

Drug

Same medications and doses as the active comparator, but with the addition of 40 mg of methylprednisolone acetate

Active Comparator

Drug

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

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

New Lexington Clinic

Other

Collaborators

  • St. Joseph's Health Care London

Registry information

Official study title

Peri-articular Injections Containing a Corticosteroid During Total Knee Arthroplasty

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Jun 27, 2007
Registry last updated
Dec 19, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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