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

Osteoarthritis Clinical Trial

Official title:

Peri-articular Injections Containing a Corticosteroid During Total Knee Arthroplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00492973
• Other study ID #: LCO.2006.2
• Status: Completed
• Phase: N/A
• First received: June 25, 2007
• Last updated: October 29, 2013
• Start date: March 2006
• Est. completion date: February 2008

Study information

• Verified date: April 2013
• Source: New Lexington Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 95 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Osteoarthritis
• Post-traumatic; Arthrosis

Intervention

Drug:
• methylprednisolone acetate
Same medications and doses as the active comparator, but with the addition of 40 mg of methylprednisolone acetate
• active comparator
bupivacaine HCl 80 mg, morphine 4 mg, epinephrine 300 micrograms, clonidine 100 micrograms, cefuroxime 750 mg, and normal saline

Locations

Country	Name	City	State
United States	Lexington Clinic Sports Medicine Center	Lexington	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
New Lexington Clinic	St. Joseph's Health Care London

Country where clinical trial is conducted

United States, 

References & Publications (2)

Lombardi AV Jr, Berend KR, Mallory TH, Dodds KL, Adams JB. Soft tissue and intra-articular injection of bupivacaine, epinephrine, and morphine has a beneficial effect after total knee arthroplasty. Clin Orthop Relat Res. 2004 Nov;(428):125-30. — View Citation

Parvataneni HK, Ranawat AS, Ranawat CS. The use of local periarticular injections in the management of postoperative pain after total hip and knee replacement: a multimodal approach. Instr Course Lect. 2007;56:125-31. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of Hospital Stay		days after surgery	No
Primary	Knee Range of Motion		3 months	No
Primary	Knee Society Scores	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	No
Primary	Amount of Pain Medication Taken Per Day		Average of 3 days after surgery	Yes
Primary	Patient Satisfaction		6 weeks, 3 months, and 1 year postoperative	No
Primary	Complications, Such as Infections, Hospital Readmissions, Manipulations Under Anesthesia, Etc.		any point during the first postoperative year	Yes