Trial Outcomes & Findings for Steroids in Total Knee Arthroplasty (NCT NCT02219581)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

1 participants

Primary outcome timeframe

Baseline, end of hospital stay (up to 3 days), 1, 4, and 12 months post-operatively

Results posted on

2022-10-04

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.	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.
Overall Study STARTED	0	0	1
Overall Study COMPLETED	0	0	1
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Steroids in Total Knee Arthroplasty

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dexamethasone 20 mg n=1 Participants 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.
Age, Categorical <=18 years	0 Participants n=1 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=1 Participants
Age, Categorical >=65 years	1 Participants n=1 Participants
Region of Enrollment United States	1 Participants n=1 Participants

PRIMARY outcome

Timeframe: Baseline, end of hospital stay (up to 3 days), 1, 4, and 12 months post-operatively

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.

Outcome measures

Outcome measures
Measure	Dexamethasone 20 mg n=1 Participants 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.
Pain Score Baseline	3 units on a scale
Pain Score End of hospital stay (up to 3 days post-operative)	0 units on a scale
Pain Score 1 month post-operative	0 units on a scale
Pain Score 4 months post-operative	3 units on a scale
Pain Score 12 months post-operative	0 units on a scale

PRIMARY outcome

Timeframe: 1 day post-operatively

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.

Outcome measures

Outcome measures
Measure	Dexamethasone 20 mg n=1 Participants 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.
Opioid Analgesic Usage	37.5 Oral Morphine Equivalents (OME)

SECONDARY outcome

Timeframe: 1 day post-operatively

Population: Measurements of knee circumference were not obtained at any study time point, or measurements have been lost and are no longer available.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 1 day post-operatively, 1, 4, and 12 months 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.

Outcome measures

Outcome measures
Measure	Dexamethasone 20 mg n=1 Participants 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.
Range of Motion (ROM) Baseline	125 degrees
Range of Motion (ROM) 1 Day Post-Operative	105 degrees
Range of Motion (ROM) 1 Month Post-Operative	135 degrees
Range of Motion (ROM) 4 Months Post-Operative	140 degrees
Range of Motion (ROM) 12 Months Post-Operative	110 degrees

SECONDARY outcome

Timeframe: Up to 3 days post-operatively

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.

Outcome measures

Outcome measures
Measure	Dexamethasone 20 mg n=1 Participants 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.
Post-operative Day of Physical Therapy Clearance	3 days

SECONDARY outcome

Timeframe: Post-operative Days 1 and 2

Post-operative nausea and/or vomiting was assessed by the use of the antiemetic Zofran, which was administered as-needed.

Outcome measures

Outcome measures
Measure	Dexamethasone 20 mg n=1 Participants 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.
Antiemetic Dose Administered Post-operative Day 1	4 milligrams (mg)
Antiemetic Dose Administered Post-operative Day 2	0 milligrams (mg)

SECONDARY outcome

Timeframe: Baseline, Post-operative Day 1

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).

Outcome measures

Outcome measures
Measure	Dexamethasone 20 mg n=1 Participants 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.
Blood Glucose Baseline	100 mg/dL
Blood Glucose Post-operative Day 1	88 mg/dL

SECONDARY outcome

Timeframe: Baseline, 12 months post-operatively

Population: SF-36 scores are not available. The survey was either not administered or scores have been lost.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 1, 4, and 12 months post-operatively

Population: KOOS, JR. scores are not available. The survey was either not administered or scores have been lost.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 3 days post-operatively

The length of hospital stay in days is reported here. A higher number of days in the hospital indicates slower recovery.

Outcome measures

Outcome measures
Measure	Dexamethasone 20 mg n=1 Participants 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.
Length of Hospital Stay	3 days

SECONDARY outcome

Timeframe: Up to 12 months post-operatively

The number of participants with hospital readmissions after being discharged were recorded.

Outcome measures

Outcome measures
Measure	Dexamethasone 20 mg n=1 Participants 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.
Number of Participants Readmitted to the Hospital	0 Participants

SECONDARY outcome

Timeframe: Up to 12 months post-operatively

The number of participants with the clinical presence of wound drainage and periprosthetic infection were recorded.

Outcome measures

Outcome measures
Measure	Dexamethasone 20 mg n=1 Participants 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.
Number of Participants With Wound Infections	0 Participants

Adverse Events

Dexamethasone 20 mg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Thomas L. Bradbury, MD

Emory University

Phone: 404-759-3912

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place