N/A
N=76
Do Corticosteroid Injections During Total Knee Replacement Improve Early Clinical Results?
Osteoarthritis · Post-traumatic; Arthrosis
Bottom Line
View on ClinicalTrials.gov: NCT00492973 ↗Enrolled (actual)
76
Serious AEs
1.3%
Results posted
Dec 2013
Primary outcome: Primary: Length of Hospital Stay — 3.5; 2.6 days
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- methylprednisolone acetate (Drug); active comparator (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- New Lexington Clinic
- Primary completion
- Feb 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Length of Hospital Stay |
3.5; 2.6 | — |
| PRIMARY Knee Range of Motion |
112.5; 112.4 | — |
| PRIMARY Knee Society Scores |
87.1; 83.3 | — |
| PRIMARY Amount of Pain Medication Taken Per Day |
47.8; 46.0 | — |
| PRIMARY Patient Satisfaction |
— | — |
| PRIMARY Complications, Such as Infections, Hospital Readmissions, Manipulations Under Anesthesia, Etc. |
0; 3 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00492973). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.