Effect of Steroids on Thrombosis (Blood Clot Formation) and Inflammation in Patients Undergoing Hip Surgery
|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.|
|ClinicalTrials.gov Identifier: NCT01782859|
Recruitment Status : Completed
First Posted : February 4, 2013
Results First Posted : May 10, 2016
Last Update Posted : January 5, 2017
|Condition or disease||Intervention/treatment||Phase|
|Total Hip Replacement||Drug: Prednisone Drug: Hydrocortisone Drug: Placebo (for Prednisone)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Effect of Steroids Given Over 24 Hours on Cytokine Release, Urinary Desmosine Level and Thrombogenic Markers in Patients Undergoing Unilateral Total Hip Replacement|
|Study Start Date :||October 2012|
|Actual Primary Completion Date :||January 2014|
|Actual Study Completion Date :||January 2014|
Placebo Comparator: Placebo
Drug: Placebo (for Prednisone)
Other Name: Lactose filler to mimic 20 mg prednisone tablet
Active Comparator: Prednisone/hydrocortisone
Steroid group will receive the following:
- Serum Prothrombin Fragment 1 and 2 (PF 1.2) [ Time Frame: First 24 hours after surgery ]
- Plasmin-a 2 Antiplasmin Complex (PAP) [ Time Frame: First 24 hours after surgery ]
- Interleukin (IL)-6 Cytokine Release (Inflammatory Marker) [ Time Frame: Participants will be followed from the time of surgery until discharge, expected average of 3-5 days ]The time frame of the study for each patient covers the period between time of surgery and until discharge from the hospital.
- Desmosine Level (Marker of Lung Injury) [ Time Frame: Participants will be followed from the time of surgery until discharge, expected average of 3-5 days ]The time frame of the study for each patient covers the period between time of surgery and until discharge from the hospital.
- Pain at 3 Months Post-op [ Time Frame: 3 months postoperatively ]At 3 months postoperatively, patients were asked to rate their pain on a scale of 0-10, with 0 being no pain and 10 being worst pain.
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 ClinicalTrials.gov identifier (NCT number): NCT01782859
|United States, New York|
|Hospital for Special Surgery|
|New York, New York, United States, 10021|