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Trial Outcomes & Findings for Pain and Function After Orthopedic Surgery (NCT NCT01390298)

NCT ID: NCT01390298

Last Updated: 2019-02-19

Results Overview

McGill Pain Questionnaire: 0-10 Visual Analog Scale for self reported pain intensity 0= no pain 10= worst pain imaginable Lower score denotes better outcomes Visual Analog Scores were obtained during the following times: Twice daily: day of hospital discharge through postoperative day 14 Once daily postoperative day 15 through postoperative day 28 Once weekly postoperative day 29 through postoperative day 85 Once monthly postoperative day 86 through postoperative day 168 Longitudinal analysis of primary outcome measure over time was estimated by longitudinal mixed models and not one mean and standard deviation. The change in pain over time was modeled by 7.7344 - 1.6013(log(time))

Recruitment status

COMPLETED

Target enrollment

55 participants

Primary outcome timeframe

Day of hospital discharge to postoperative day 168

Results posted on

2019-02-19

Participant Flow

Participant milestones

Participant milestones
Measure
All Study Participants
Adult patients scheduled for elective unicompartmental or total knee replacement surgery or total hip replacment Observational: Observational study only
Overall Study
STARTED
55
Overall Study
COMPLETED
31
Overall Study
NOT COMPLETED
24

Reasons for withdrawal

Reasons for withdrawal
Measure
All Study Participants
Adult patients scheduled for elective unicompartmental or total knee replacement surgery or total hip replacment Observational: Observational study only
Overall Study
Death
1
Overall Study
long term ICU admission
1
Overall Study
Withdrawal by Subject
14
Overall Study
Lost to Follow-up
7
Overall Study
Surgery cancelled
1

Baseline Characteristics

Pain and Function After Orthopedic Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
All Study Participants
n=40 Participants
Adult patients scheduled for elective unicompartmental or total knee replacement surgery or total hip replacement will be consented to participate Observational: Observational study only
Age, Categorical
<=18 years
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
26 Participants
n=5 Participants
Age, Categorical
>=65 years
14 Participants
n=5 Participants
Age, Continuous
60.35 years
n=5 Participants
Sex: Female, Male
Female
22 Participants
n=5 Participants
Sex: Female, Male
Male
18 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
8 Participants
n=5 Participants
Race (NIH/OMB)
White
32 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
Region of Enrollment
United States
40 participants
n=5 Participants

PRIMARY outcome

Timeframe: Day of hospital discharge to postoperative day 168

Population: Lower Extremity Total Joint Arthroplasty (TJS) Cohort (n=31)

McGill Pain Questionnaire: 0-10 Visual Analog Scale for self reported pain intensity 0= no pain 10= worst pain imaginable Lower score denotes better outcomes Visual Analog Scores were obtained during the following times: Twice daily: day of hospital discharge through postoperative day 14 Once daily postoperative day 15 through postoperative day 28 Once weekly postoperative day 29 through postoperative day 85 Once monthly postoperative day 86 through postoperative day 168 Longitudinal analysis of primary outcome measure over time was estimated by longitudinal mixed models and not one mean and standard deviation. The change in pain over time was modeled by 7.7344 - 1.6013(log(time))

Outcome measures

Outcome measures
Measure
All Study Participants
n=31 Participants
Adult patients scheduled for elective unicompartmental or total knee replacement surgery or total hip replacment Observational: Observational study only
Self-reported Pain Intensity
3 units on a scale
Standard Deviation 2.9

Adverse Events

Observational

Serious events: 1 serious events
Other events: 1 other events
Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure
Observational
n=31 participants at risk
Adult patients scheduled for elective unicompartmental or total knee replacement surgery or total hip replacment Observational: Observational study only
Cardiac disorders
Subject experienced myocardial infarction during the immediate postoperative period
3.2%
1/31 • Number of events 1 • 6 months

Other adverse events

Other adverse events
Measure
Observational
n=31 participants at risk
Adult patients scheduled for elective unicompartmental or total knee replacement surgery or total hip replacment Observational: Observational study only
General disorders
Subject experienced postoperative complications resulting in long term hospitializaton
3.2%
1/31 • Number of events 1 • 6 months

Additional Information

James C. Eisenach, M.D.

Wake Forest School of Medicine

Phone: 336-716-4498

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place