Not provided
Not provided
Not provided
Not provided
Not provided
Terminated after considerable time in suspended state due to inadequate staffing, the COVID pandemic, and the Responsible Party leaving Emory in August 2022.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Adequate pain control after total knee arthroplasty (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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | 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. |
|
| Dexamethasone 10 mg | Experimental | 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. |
|
| Dexamethasone 20 mg | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone 10 mg | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Score | Post-operative pain was 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 participant was asked to choose the face that best describes their level of pain. Higher scores indicate higher intensities of pain. | Baseline, end of hospital stay (up to 3 days), 1, 4, and 12 months post-operatively |
| Opioid Analgesic Usage | The amount of post-operative opioid analgesic usage is assessed as Oral Morphine Equivalents (OME) which is the amount of an oral morphine drug that would be necessary to equal the pain treatment from opioid morphine. | 1 day post-operatively |
| Measure | Description | Time Frame |
|---|---|---|
| Soft Tissue Swelling | Evaluation of soft tissue swelling uses a measurement of knee circumference at the midpoint of the patella, with the knee in the maximum amount of extension allowed by the patient. | 1 day post-operatively |
| Range of Motion (ROM) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Thomas L Bradbury, MD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory Orthopedic and Spine Hospital | Tucker | Georgia | 30084 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants undergoing primary total joint arthroplasty of the knee who are randomized to 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. |
| FG001 | Dexamethasone 10 mg | Participants undergoing primary total joint arthroplasty of the knee who are randomized to 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, participants will also receive a standard multimodal postoperative pain management regimen typically used for total knee arthroplasty. |
| FG002 | Dexamethasone 20 mg | Participants undergoing primary total joint arthroplasty of the knee who are randomized to 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, participants will also receive a standard multimodal postoperative pain management regimen typically used for total knee arthroplasty. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Dexamethasone 20 mg | The participant undergoing primary total joint arthroplasty of the knee was randomized to receive two doses of 20 mg dexamethasone. The first dose was given preoperatively within 3 hours of surgery and the second dose was administered 8 hours after the first dose in the inpatient setting. Additionally, the participant received a standard multimodal postoperative pain management regimen typically used for total knee arthroplasty. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pain Score | Post-operative pain was 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 participant was asked to choose the face that best describes their level of pain. Higher scores indicate higher intensities of pain. | Posted | Number | units on a scale | Baseline, end of hospital stay (up to 3 days), 1, 4, and 12 months post-operatively |
|
Information on adverse events was collected from medical records beginning at the baseline assessment just prior to surgery and continued through the 12 month post-operative assessment (for 12 months total).
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dexamethasone 20 mg | The participant undergoing primary total joint arthroplasty of the knee was randomized to receive two doses of 20 mg dexamethasone. The first dose was given preoperatively within 3 hours of surgery and the second dose was administered 8 hours after the first dose in the inpatient setting. Additionally, the participant received a standard multimodal postoperative pain management regimen typically used for total knee arthroplasty. |
Not provided
Not provided
There are limitations of the study results due to termination of the study and a small number of study participants.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thomas L. Bradbury, MD | Emory University | 404-759-3912 | tombradburymd@gmail.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 1, 2016 | Aug 31, 2022 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D007249 | Inflammation |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
Not provided
Not provided
| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| D002123 | Calcium Dobesilate |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Dexamethasone 20 mg | Drug | 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. |
|
|
| Standard multimodal pain management regimen | Drug | The standard multimodal postoperative pain management regimen typically used for total knee arthroplasty consists of the following: Preoperative:
Intraoperative:
Postoperative
|
|
| Placebo | Drug | 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. |
|
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.
| Baseline, 1 day post-operatively, 1, 4, and 12 months post-operatively |
| Post-operative Day of Physical Therapy Clearance | The post-operative day when the participant was cleared by the physical therapy staff to go home was recorded. A shorter clearance time is indicative of better joint function. | Up to 3 days post-operatively |
| Antiemetic Dose Administered | Post-operative nausea and/or vomiting was assessed by the use of the antiemetic Zofran, which was administered as-needed. | Post-operative Days 1 and 2 |
| Blood Glucose | To assess postoperative glucose levels after steroid administration, blood glucose level will be analyzed using a HemoCue testing system. Diabetes is indicated with a random blood glucose measurement of greater than 200 milligrams per deciliter (mg/dL). | Baseline, Post-operative Day 1 |
| 36-Item Short Form Health Survey (SF-36) Score | The subjects' functional ability will be assessed using the SF-36 questionnaire. The SF-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. | Baseline, 12 months post-operatively |
| Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR.) Score | The KOOS, JR. instrument has 7 items assessing knee stiffness, knee pain, and daily living physical function following knee joint replacement. Responses are given on a 5-point scale where 0 = no pain or disability and 4 = extreme pain or disability. Total raw scores range from 0 to 28, where higher scores indicate increased pain or disability. Total raw scores can be converted to an interval score ranging from 0 to 100 where 0 = total knee disability and 100 = perfect knee health. | Baseline, 1, 4, and 12 months post-operatively |
| Length of Hospital Stay | The length of hospital stay in days is reported here. A higher number of days in the hospital indicates slower recovery. | Up to 3 days post-operatively |
| Number of Participants Readmitted to the Hospital | The number of participants with hospital readmissions after being discharged were recorded. | Up to 12 months post-operatively |
| Number of Participants With Wound Infections | The number of participants with the clinical presence of wound drainage and periprosthetic infection were recorded. | Up to 12 months post-operatively |
| Participants |
|
| Sex: Female, Male | To maintain anonymity of the single participant of this study sex is not reported. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| Primary | Opioid Analgesic Usage | The amount of post-operative opioid analgesic usage is assessed as Oral Morphine Equivalents (OME) which is the amount of an oral morphine drug that would be necessary to equal the pain treatment from opioid morphine. | Posted | Number | Oral Morphine Equivalents (OME) | 1 day post-operatively |
|
|
|
| Secondary | Soft Tissue Swelling | Evaluation of soft tissue swelling uses a measurement of knee circumference at the midpoint of the patella, with the knee in the maximum amount of extension allowed by the patient. | Measurements of knee circumference were not obtained at any study time point, or measurements have been lost and are no longer available. | Posted | 1 day post-operatively |
|
|
| Secondary | Range of Motion (ROM) | 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. | Posted | Number | degrees | Baseline, 1 day post-operatively, 1, 4, and 12 months post-operatively |
|
|
|
| Secondary | Post-operative Day of Physical Therapy Clearance | The post-operative day when the participant was cleared by the physical therapy staff to go home was recorded. A shorter clearance time is indicative of better joint function. | Posted | Number | days | Up to 3 days post-operatively |
|
|
|
| Secondary | Antiemetic Dose Administered | Post-operative nausea and/or vomiting was assessed by the use of the antiemetic Zofran, which was administered as-needed. | Posted | Number | milligrams (mg) | Post-operative Days 1 and 2 |
|
|
|
| Secondary | Blood Glucose | To assess postoperative glucose levels after steroid administration, blood glucose level will be analyzed using a HemoCue testing system. Diabetes is indicated with a random blood glucose measurement of greater than 200 milligrams per deciliter (mg/dL). | Posted | Number | mg/dL | Baseline, Post-operative Day 1 |
|
|
|
| Secondary | 36-Item Short Form Health Survey (SF-36) Score | The subjects' functional ability will be assessed using the SF-36 questionnaire. The SF-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. | SF-36 scores are not available. The survey was either not administered or scores have been lost. | Posted | Baseline, 12 months post-operatively |
|
|
| Secondary | Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR.) Score | The KOOS, JR. instrument has 7 items assessing knee stiffness, knee pain, and daily living physical function following knee joint replacement. Responses are given on a 5-point scale where 0 = no pain or disability and 4 = extreme pain or disability. Total raw scores range from 0 to 28, where higher scores indicate increased pain or disability. Total raw scores can be converted to an interval score ranging from 0 to 100 where 0 = total knee disability and 100 = perfect knee health. | KOOS, JR. scores are not available. The survey was either not administered or scores have been lost. | Posted | Baseline, 1, 4, and 12 months post-operatively |
|
|
| Secondary | Length of Hospital Stay | The length of hospital stay in days is reported here. A higher number of days in the hospital indicates slower recovery. | Posted | Number | days | Up to 3 days post-operatively |
|
|
|
| Secondary | Number of Participants Readmitted to the Hospital | The number of participants with hospital readmissions after being discharged were recorded. | Posted | Count of Participants | Participants | Up to 12 months post-operatively |
|
|
|
| Secondary | Number of Participants With Wound Infections | The number of participants with the clinical presence of wound drainage and periprosthetic infection were recorded. | Posted | Count of Participants | Participants | Up to 12 months post-operatively |
|
|
|
| 0 |
| 1 |
| 0 |
| 1 |
| 0 |
| 1 |
Not provided
Not provided
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D001557 | Benzenesulfonates |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D001190 | Arylsulfonates |
| D017739 | Arylsulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| Title | Measurements |
|---|---|
|
| 4 Months Post-Operative |
|
| 12 Months Post-Operative |
|