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Steroids in Total Knee Arthroplasty

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: NCT02219581
Recruitment Status : Suspended (Suspended pending acquisition of additional study staff.)
First Posted : August 19, 2014
Last Update Posted : November 19, 2019
Sponsor:
Information provided by (Responsible Party):
Thomas L Bradbury, MD, Emory University

Tracking Information
First Submitted Date  ICMJE August 13, 2014
First Posted Date  ICMJE August 19, 2014
Last Update Posted Date November 19, 2019
Study Start Date  ICMJE August 2014
Estimated Primary Completion Date November 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 23, 2015)
  • Change in pain scores [ Time Frame: Baseline, 48 hours post-operatively (average length of inpatient stay) ]
    Postoperative pain will be assessed using the well-standardized and accepted visual analog pain scale. The scale shows a series of faces ranging from a happy face at 0= "No hurt", to a crying face at 10= "Hurts worst". The subject will be asked to choose the face that best describes their level of pain and their responses will be recorded. Higher scores indicate higher intensities of pain.
  • Pain scores as recorded by the smart device app [ Time Frame: 7 days post-operatively ]
    Subjects will answer questions about their pain and record their responses using the app on their smart device.
  • Change in pain scores [ Time Frame: 1 month post-operatively, 12 months post-operatively ]
    Postoperative pain will be assessed using the well-standardized and accepted visual analog pain scale. The scale shows a series of faces ranging from a happy face at 0= "No hurt", to a crying face at 10= "Hurts worst". The subject will be asked to choose the face that best describes their level of pain and their responses will be recorded. Higher scores indicate higher intensities of pain.
  • Opioid analgesic usage [ Time Frame: Baseline, 2 weeks post-operatively ]
    The amount of each subject's postoperative opioid analgesic usage (converted into milligrams of morphine equivalents per day) will be recorded. The subjects will be asked to use a pain medication usage log to track the use of both prescribed narcotic medications and over the counter non-steroidal anti-inflammatory medications for knee pain.
Original Primary Outcome Measures  ICMJE
 (submitted: August 16, 2014)
  • Pain Scores [ Time Frame: Up to 1 year ]
    Postoperative pain will be assessed using the well-standardized and accepted visual analog pain scale. This data will be recorded at baseline, during the hospital stay, and at all follow-up visits. Furthermore, during the hospital stay this data will be recorded with each vital sign assessment by the nursing staff every four hours.
  • Patient controlled analgesic usage [ Time Frame: Up to 1 year ]
    The amount of each patient's postoperative opioid analgesic usage (converted into milligrams of morphine equivalents per day) will be recorded throughout the duration of their hospital stay. After discharge, patients will be provided with a pain medication usage log to track the use of both prescribed narcotic medications and over the counter non-steroidal anti-inflammatory medications for knee pain. Patients will be asked to use this log from the time of discharge up until their first follow up clinic visit at 1 month +/- 1 week. During the 7-day postoperative telephone interview, patients will be reminded to use their medication log.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 23, 2015)
  • Soft tissue swelling [ Time Frame: Baseline, 1 day post-operatively ]
    Soft tissue swelling will be evaluated using a measurement of knee circumference at the midpoint of the patella, with the knee in the maximum amount of extension allowed by the patient. This measurement will be completed twice, and the average of the two measurements will be used as the value for that day.
  • Soft tissue swelling [ Time Frame: 1 month post-operatively, 12 months post-operatively ]
    Soft tissue swelling will be evaluated using a measurement of knee circumference at the midpoint of the patella, with the knee in the maximum amount of extension allowed by the patient. This measurement will be completed twice, and the average of the two measurements will be the value for that day.
  • Change in range of motion (ROM) [ Time Frame: Baseline, 1 day post-operatively ]
    Maximum passive ROM allowed by the patient will be measured using a goniometer. The ROM measurement is the amount of flexion and extension recorded in degrees. An increased ROM is indicative of better joint mobility.
  • Change in range of motion (ROM) [ Time Frame: 1 month post-operaively, 12 months post-opreatively ]
    Maximum passive ROM allowed by the patient will be measured using a goniometer. The ROM measurement is the amount of flexion and extension recorded in degrees. An increased ROM is indicative of better joint mobility.
  • Time to clearance from physical therapy [ Time Frame: 2 days post-operatively ]
    The post-operative day when the subject is cleared by the physical therapy staff to go home will be recorded. A shorter clearance time is indicative of better joint function.
  • Post-operative nausea [ Time Frame: Up to 1 month post-operatively ]
    The use of as-needed antiemetics will be recorded for each subject. Subjects will also be specifically asked about episodes of emesis using the BARF scale where each item is scored from 0= no nausea to 10= emesis.
  • Post-operative vomiting [ Time Frame: Up to 1 month post-operatively ]
    The use of as-needed antiemetics will be recorded for each subject. Subjects will also be specifically asked about episodes of emesis using the BARF scale where each item is scored from 0= no nausea to 10= emesis.
  • Levels of blood glucose [ Time Frame: Baseline, 48 hours post-operatively ]
    The subject's blood glucose level will be analyzed using a Hemocue analyzer.
  • Functionality scores using Short Form using (SF)-36 [ Time Frame: Baseline, 12 months post-operatively ]
    The subjects' functional ability will be assessed using the Short Form (SF)-36 questionnaire. The Short Form-36 Health Survey is a 36-item, self-reported survey of patient health and is a measure of health status. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability.
  • Functionality scores using (WOMAC) [ Time Frame: Baseline, 12 months post-operatively ]
    The and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaire will be used to assess joint function. administered to patients at the baseline visit and at each follow up clinic visit. The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
  • Length of hospital stay [ Time Frame: 12 months post-operatively ]
    The length of each subject's hospital stay in days will be recorded. Higher number of days in the hospital indicate slower recovery.
  • Number of hospital readmissions [ Time Frame: 12 months post-operatively ]
    The number of subjects who need readmission to the hospital will be recorded.
  • Number of subjects with wound infections [ Time Frame: 1 month post-operatively, 12 months post-operatively ]
    The number of subjects with the clinical presence of wound drainage and periprosthetic infection will be recorded.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 16, 2014)
  • Soft tissue swelling [ Time Frame: Up to 1 year ]
    Soft tissue swelling will be evaluated using a measurement of knee circumference at the midpoint of the patella, with the knee in the maximum amount of extension allowed by the patient. This measurement will be completed twice, and the average of the two measurements will be used as the value for that day. Knee circumference will be measured at baseline (time of enrollment), at POD 1 and each subsequent in-hospital POD, and at each follow up visit. The measurements obtained at baseline and at each clinic visit will be conducted by the research coordinator or physician. Postoperative measurements obtained during the patient's hospital stay will be conducted by the physical therapy staff, during the first/morning therapy session of each day. The non-operative knee will also be measured at the time of enrollment to use as a reference.
  • Range of motion (ROM) [ Time Frame: Up to 1 year ]
    Maximum passive ROM allowed by the patient will be measured using a goniometer. This measurement is the amount of flexion and extension recorded in degrees. ROM will be measured at the following time points: preoperatively at baseline, at POD 1 and each subsequent in-hospital POD, and at each follow up visit. ROM will be measured on postoperative in-hospital days by a physical therapist, whereas ROM at clinic visits will be measured by the research coordinator or physician. If more than one ROM measurement is obtained during an inpatient day, the numbers will be averaged to create one value for that day.
  • Time to clearance from physical therapy [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 2.3 days ]
    The POD when each patient is cleared by the physical therapy staff to go home will be recorded. This will be evaluated by a physical therapist and documented in the medical record. Patients who ultimately end up being transferred to a subacute rehabilitation facility will be excluded from this outcome analysis.
  • Nausea/Vomiting Assessment [ Time Frame: Up to 1 month ]
    The use of as-needed antiemetics will be recorded for each patient. Any incident of emesis will also be recorded by the patient's nurse. Patients will also be specifically asked about episodes of emesis in a standardized fashion during the 7-day phone interview. This data is being collected because nausea and/or vomiting are well-known side effects of narcotic usage.
  • Blood Glucose Levels [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 2.3 days ]
    The patient's blood glucose level will be recorded once preoperatively at the pre-anesthesia clinic visit several days before surgery, at POD 1 and at each subsequent in-hospital POD using a basic metabolic panel. These do not consist of extra blood tests, as blood draws at these time points are considered standard of care. This data is being collected because hyperglycemia is a potential complication of IV steroid use.
  • Functionality scores [ Time Frame: Up to 1 year ]
    The Short Form (SF) - 36 and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaires will be administered to patients at the baseline visit and at each follow up clinic visit. Both of these standardized function questionnaires are well validated and widely accepted in the literature.
  • Hospital length of stay and readmission [ Time Frame: Up to 1 year ]
    Investigators will record the length of each patient's hospital stay and any readmission to our hospital for the 12-month duration of study.
  • Infection [ Time Frame: Up to 1 year ]
    Patients will be evaluated by telephone on POD 7 for the presence or absence of wound drainage. Specifically, they will be asked if they "are experiencing drainage that escaped the seal of the transparent dressing over the wound." This way, answers will be standardized (yes/no). Additionally, patients will have standard follow up clinic appointments at 1 month and 4 months after surgery, at which time the clinical presence of possible wound and periprosthetic infection will be evaluated. Patients will be followed up to 1 year after surgery to monitor for latent infections.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Steroids in Total Knee Arthroplasty
Official Title  ICMJE Evaluation of Intravenous Glucocorticoid Therapy in Total Knee Arthroplasty
Brief Summary The purpose of this study is to evaluate if the use of two small doses of intravenous (IV) steroids around the time of knee replacement surgery decrease a patient's pain or use of pain medication. The investigators will also determine if the subjects receiving the steroid will have better pain control and better postoperative outcomes after their surgery.
Detailed Description Adequate pain control after total knee replacement (TKA) is of great importance not only to maximize patient comfort, but also to ensure optimal outcomes after surgery. This study is designed to assess whether the use of two small doses of intravenous (IV) steroids around the time of surgery decrease a patient's pain or use of pain medication. Secondly, the investigators will also determine if the use of these steroids as part of a multimodal pain management strategy leads to improved patient outcomes, including pain, nausea and vomiting, knee function and length of stay in the hospital after surgery. The study will compare the effect of two different doses of IV dexamethasone given preoperatively before TKA, when compared to placebo.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Postoperative Pain
  • Inflammation
  • Osteoarthritis
Intervention  ICMJE
  • Drug: Dexamethasone 10 mg
    Two doses of dexamethasone 10 mg will be given intravenously. The first dose will be given preoperatively within 3 hours of surgery and the second dose will be administered 8 hours after the first dose in the inpatient setting.
    Other Name: Decadron
  • Drug: Dexamethasone 20 mg
    Two doses of dexamethasone 20 mg will be given intravenously. The first dose will be given preoperatively within 3 hours of surgery and the second dose will be administered 8 hours after the first dose in the inpatient setting.
    Other Name: Decadron
  • Drug: Standard multimodal pain management regimen

    The standard multimodal postoperative pain management regimen typically used for total knee arthroplasty consists of the following:

    Preoperative:

    • Decadron: 10 or 20mg IV x 1 2 doses, 8 hours apart (if randomized to study group)

    Intraoperative:

    • Ropivacaine: Given intraoperatively. Capsule, subcutaneous tissue/skin. Administered in standard fashion. (300mg)
    • Toradol: 30mg q 6hr for 6 total doses. 1st dose given intraoperatively at incision. (15 mg if older patient or CrCl low)

    Postoperative

    • Tylenol: 1000mg po q 8hr (scheduled)
    • Oxycodone: 5mg or 10mg q 3-4hr prn pain, If intolerant to Oxycodone: second agent line is Hydrocodone or Oral Dilaudid
    • IV Morphine (or Dilaudid): 1 or 2 mg q 2hr prn breakthrough pain
    • Morphine PCA: only for failure of the above
    • MS Contin: Use as backup prn pain
  • Drug: Placebo
    Participants in the placebo arm will receive two doses of saline intravenously. The first dose will be given preoperatively within 3 hours of surgery and the second dose will be administered 8 hours after the first dose in the inpatient setting.
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Subjects undergoing primary total joint arthroplasty of the knee will receive two doses of placebo intravenously in addition to a standard multimodal postoperative pain management regimen typically used for total knee arthroplasty. The first dose of placebo will be given preoperatively within 3 hours of surgery and the second dose will be administered 8 hours after the first dose in the inpatient setting.
    Interventions:
    • Drug: Standard multimodal pain management regimen
    • Drug: Placebo
  • Experimental: Dexamethasone 10 mg
    Subjects undergoing primary total joint arthroplasty of the knee will receive two doses of 10 mg dexamethasone. The first dose will be given preoperatively within 3 hours of surgery and the second dose will be administered 8 hours after the first dose in the inpatient setting. Additionally, subjects will also receive a standard multimodal postoperative pain management regimen typically used for total knee arthroplasty.
    Interventions:
    • Drug: Dexamethasone 10 mg
    • Drug: Standard multimodal pain management regimen
  • Experimental: Dexamethasone 20 mg
    Subjects undergoing primary total joint arthroplasty of the knee will receive two doses of 20 mg dexamethasone. The first dose will be given preoperatively within 3 hours of surgery and the second dose will be administered 8 hours after the first dose in the inpatient setting. Additionally, subjects will also receive a standard multimodal postoperative pain management regimen typically used for total knee arthroplasty.
    Interventions:
    • Drug: Dexamethasone 20 mg
    • Drug: Standard multimodal pain management regimen
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: October 23, 2015)
150
Original Estimated Enrollment  ICMJE
 (submitted: August 16, 2014)
170
Estimated Study Completion Date  ICMJE November 2021
Estimated Primary Completion Date November 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients undergoing primary total joint arthroplasty of the knee
  • Adult patients ages 18-100 years
  • Patients must have smart phone and/or device for app usage

Exclusion Criteria:

  • Current chronic steroid use
  • Patients undergoing revision knee surgery
  • Patients ambulating preoperatively with assistive devices
  • Patients with avascular necrosis of the operative knee
  • Patients with a history of an adverse reaction to glucocorticoid steroids
  • Patients unable to provide informed consent
  • Patients with inflammatory arthritis
  • Prisoners
  • Current smokers
  • Patients <18 years of age
  • Any patient with a complicated postoperative course that requires transfer to the Intensive Care Unit (ICU) or to another facility for further management will be removed from the study.
  • Any contraindication that would prevent the patient from being treated with the standard multimodal postoperative pain management regimen History of infection of surgical knee.
  • Patients with diabetes.
  • Patients that have an intolerance to Toradol.
  • Patients that do not have smart phone and/or device for app usage
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02219581
Other Study ID Numbers  ICMJE IRB00066081
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Thomas L Bradbury, MD, Emory University
Study Sponsor  ICMJE Emory University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Thomas L Bradbury, MD Emory University
PRS Account Emory University
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP