Do Corticosteroid Injections During Total Knee Replacement Improve Early Clinical Results?
NCT ID: NCT00492973
Last Updated: 2013-12-19
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
101 participants
INTERVENTIONAL
2006-03-31
2008-02-29
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
active comparator
bupivacaine HCl 80 mg, morphine 4 mg, epinephrine 300 micrograms, clonidine 100 micrograms, cefuroxime 750 mg, and normal saline
Corticosteroid
Patients in the Corticosteroid group will have the same medications as the Control Group with the addition of a corticosteroid (methylprednisolone acetate)
methylprednisolone acetate
Same medications and doses as the active comparator, but with the addition of 40 mg of methylprednisolone acetate
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Has elected to undergo total knee replacement
Exclusion Criteria
* 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
18 Years
95 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
St. Joseph's Health Care London
OTHER
New Lexington Clinic
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Christian P Christensen, MD
Role: PRINCIPAL_INVESTIGATOR
New Lexington Clinic
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Lexington Clinic Sports Medicine Center
Lexington, Kentucky, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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. doi: 10.1097/01.blo.0000147701.24029.cc.
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.
Christensen CP, Jacobs CA, Jennings HR. Effect of periarticular corticosteroid injections during total knee arthroplasty. A double-blind randomized trial. J Bone Joint Surg Am. 2009 Nov;91(11):2550-5. doi: 10.2106/JBJS.H.01501.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
LCO.2006.2
Identifier Type: -
Identifier Source: org_study_id