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Trial record 2 of 29 for:    "Collagen Disease" | "Dexamethasone acetate"

Efficacy and Safety of Single, Low-dose Dexamethasone in Patients After Total Knee Arthroplasty

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ClinicalTrials.gov Identifier: NCT01612702
Recruitment Status : Completed
First Posted : June 6, 2012
Results First Posted : May 21, 2013
Last Update Posted : May 27, 2013
Sponsor:
Information provided by (Responsible Party):
Tae Kyun Kim, Seoul National University Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Condition Osteoarthritis, Knee
Intervention Drug: Dexamethasone
Enrollment 291
Recruitment Details 305 patients who were scheduled for unilateral total knee arthroplasty at Seoul National Bundang Hospital from April 2011 to December 2011 were recruited.
Pre-assignment Details 14 patients were excluded before assignment. 5 were other diagnosis such as rheumatoid arthritis, secondary osteoarthritis, 4 had serious medical conditions such as renal failure, heary failure, 5 refused to participate
Arm/Group Title Dexamethasone Control
Hide Arm/Group Description dexamethasone 10 mg administration 1 hour before surgery No dexamethasone
Period Title: Overall Study
Started 146 145
Completed 135 134
Not Completed 11 11
Reason Not Completed
Protocol Violation             11             11
Arm/Group Title Dexamethasone Control Total
Hide Arm/Group Description dexamethasone 10 mg administration 1 hour before surgery No dexamethasone Total of all reporting groups
Overall Number of Baseline Participants 146 145 291
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 146 participants 145 participants 291 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
14
   9.6%
14
   9.7%
28
   9.6%
>=65 years
132
  90.4%
131
  90.3%
263
  90.4%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 146 participants 145 participants 291 participants
72  (6.7) 72  (6.2) 72  (6.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 146 participants 145 participants 291 participants
Female
117
  80.1%
119
  82.1%
236
  81.1%
Male
29
  19.9%
26
  17.9%
55
  18.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Korea, Republic of Number Analyzed 146 participants 145 participants 291 participants
146 145 291
1.Primary Outcome
Title Incidence of Nausea and Vomiting
Hide Description A clinical investigator who is blinded to randomization assessed the incidence of postoperative nausea which defined as subjective unpleasant sensation associated with awareness of the urge to vomit and as emetic episode and vomiting
Time Frame within 72 hours after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dexamethasone Control
Hide Arm/Group Description:
dexamethasone 10 mg administration 1 hour before surgery
No dexamethasone
Overall Number of Participants Analyzed 146 145
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participant
24
(22.8 to 25.2)
40
(38 to 42)
2.Secondary Outcome
Title Pain Level
Hide Description A blinded investigator asked participants to recall the most severe pain level during 6 to 24 hour after surgery using with a visual analogue scale that ranged from 0 (no pain) to 10 (worst imaginable pain).
Time Frame 6 to 24 hours after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dexamethasone Control
Hide Arm/Group Description:
dexamethasone 10 mg administration 1 hour before surgery
No dexamethasone
Overall Number of Participants Analyzed 146 145
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.4  (1.0) 4.0  (2.0)
3.Secondary Outcome
Title Wound Complication
Hide Description Number of participants with a sinus tract communicating with the prosthesis; a pathogen was isolated by culture from tissue or fluid samples taken from the affected joint; tests revealed elevated serum erythrocyte sedimentation rate (ESR) or serum C-reactive protein (CRP) concentration with elevated synovial white blood cell (WBC) count or neutrophil percentage; or pus discharge from the affected joint was present within 30 days after total knee arthroplasty were measured.
Time Frame within 30 days after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dexamethasone Control
Hide Arm/Group Description:
dexamethasone 10 mg administration 1 hour before surgery
No dexamethasone
Overall Number of Participants Analyzed 146 145
Measure Type: Number
Unit of Measure: participant
1 1
Time Frame 30 days after total knee arthroplasty
Adverse Event Reporting Description wound complication such as postoperative infection, wound dehescence.
 
Arm/Group Title Dexamethasone Control
Hide Arm/Group Description dexamethasone 10 mg administration 1 hour before surgery No dexamethasone
All-Cause Mortality
Dexamethasone Control
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Dexamethasone Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/146 (0.68%)      1/145 (0.69%)    
Surgical and medical procedures     
Wound complication * [1]  1/146 (0.68%)  1 1/145 (0.69%)  1
*
Indicates events were collected by non-systematic assessment
[1]
wound compltications within 30 days after total knee arthroplasty
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Dexamethasone Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/146 (0.00%)      0/145 (0.00%)    
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. TK Kim
Organization: Joint Reconstruction Center, Seoul National University Bundang Hospital
Phone: 82-31-787-7196 ext 7200
Responsible Party: Tae Kyun Kim, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01612702     History of Changes
Other Study ID Numbers: B-1102/121-006
First Submitted: June 3, 2012
First Posted: June 6, 2012
Results First Submitted: June 6, 2012
Results First Posted: May 21, 2013
Last Update Posted: May 27, 2013