- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05137080
Dexamethasone and Functional Outcome After TKA
October 4, 2022 updated by: Asger Krog Moelgaard, Slagelse Hospital
Dexamethasone and Functional Outcome After Total Knee Arthroplasty: A 2 Year Follow up of the DEX-2-TKA-trial
Patients previously included in the DEX-2-TKA-trial (ethics committee ID SJ-695; ClinicalTrials.gov:
NCT03506789) at Næstved Hospital will be invited for a follow up study consisting of questionnaires and a visit with a physical therapist.
The study includes the following validated questionnaires: EQ-5D-5L, Oxford Knee Score and PainDetect, and information on height, weight, daily pain-medication and co-morbidities.
With the physical therapist, the patient will perform the following functional tests: knee range of motion, timed-up-to-go, 30 second chair stand test, 40m fast paced walk test, stair climb test and a measure of the thigh force.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
162
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Næstved, Denmark, 4700
- Næstved, Slagelse og Ringsted Hospitals
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Slagelse, Denmark, 4200
- Næstved, Slagelse and Ringsted Hospitals
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- participation in the DEX-2-TKA-trial at Næstved Hospital in accordance with protocol
- Signed, informed consent for participation
Exclusion Criteria:
- Lack of signed, informed consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Treatment A
24mg dexamethasone i.v.
perioperatively and 24mg dexamethasone i.v. on the first postoperative day
|
24mg dexamethasone
|
Active Comparator: Treatment B
24mg dexamethasone i.v.
perioperatively and placebo (isotonic saline) i.v. on the first postoperative day
|
24mg dexamethasone
Isotonic saline
|
Placebo Comparator: Treatment C
Placebo (isotonic saline) i.v.
perioperatively and placebo (isotonic saline) i.v. on the first postoperative day
|
Isotonic saline
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Average pain during functional performance exercises
Time Frame: 2-3 years after total knee arthroplasty
|
Average of maximal pain experienced during the functional performance exercises measured as a VAS 0-100mm with comparisons between treatment allocation group.
The average will be calculated based on measurements after each functional performance exercise (TUG, 30CST, 40FPW and SCT).
|
2-3 years after total knee arthroplasty
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
EQ-5D-5L
Time Frame: 2-3 years after total knee arthroplasty
|
Difference in performance between treatment allocation groups on the EQ-5D-5L questionnaire at follow-up.
EQ-5D-5L is comprised of five health dimensions (mobility, self-care, usual activities, pain/discomfort) which the patient must rate on a 1-5 dimension going from no problems to perform the activity to being unable to perform the activity.
In addition, the patient will rate his/her health on a 0-100 scale, where 0 being worst imaginable health and 100 being best imaginable health.
|
2-3 years after total knee arthroplasty
|
Oxford Knee Score
Time Frame: 2-3 years after total knee arthroplasty
|
Difference in performance between allocation groups on the Oxford Knee Score questionnaire at follow-up.
Oxford Knee Score is a questionnaire comprised of 12 questions regarding pnee pain and function.
Each question can be answered on a 1 (best) to 5 (worst) score and thus a overall scores can be calculated by summing op all the scores.
Best outcome would hence be a score of 12, while worst possible outcome is a score of 60.
|
2-3 years after total knee arthroplasty
|
PainDetect
Time Frame: 2-3 years after total knee arthroplasty
|
Difference in performance between allocation groups on the PainDetect questionnaire at follow-up.
The PainDetect questionnaire is comprised of 11 questions regarding strengt and character of any experienced pain.
The patients answers can then be calculated into a total score of 0-38 and further grouped into likelihood of a neuropathic component of the patients chronic pain.
If 0-12 there is <15% likelihood that the patient experiences neuropathic pain, while >18 estimates a likelihhed >90% for a neuropathic component.
13-18 points is a greyzone in between where a neuropathic component of the experienced pain cannot either be ruled in or out.
|
2-3 years after total knee arthroplasty
|
Use of opioids
Time Frame: 2-3 years after total knee arthroplasty
|
Difference in daily use of opioids between allocation groups at follow-up.
Daily use will be calculated into equivalents of mg morphine per day.
|
2-3 years after total knee arthroplasty
|
Range of Motion
Time Frame: 2-3 years after total knee arthroplasty
|
Difference in performance between allocation groups on the Range of Motion exercise at follow-up.
Range of motion is measured in degrees from fully extended to full flexion of the knee
|
2-3 years after total knee arthroplasty
|
Timed-Up-To-Go (TUG)
Time Frame: 2-3 years after total knee arthroplasty
|
Difference in performance between allocation groups on the timed-up-to-go-test exercise at follow-up assessed as time in seconds it takes to
|
2-3 years after total knee arthroplasty
|
30 second chair stand test (30CST)
Time Frame: 2-3 years after total knee arthroplasty
|
Difference in performance between allocation groups on the 30 second chair-stand-test exercise at follow-up assessed as number of repetitions performed during 30 seconds. one repetition is counted as
|
2-3 years after total knee arthroplasty
|
40 meter fast paced walk test (40FPW)
Time Frame: 2-3 years after total knee arthroplasty
|
Difference in performance between allocation groups on the 40 meter fast paced walk test exercise at follow-up assessed as walk speed in meters pr.
second.
The exercised is performed by the patient walkning as highest possible speed between to lines on the floor 10 meters apart from each other.
A timer is started eache time the patient crossess the line and paused, when the patient is at the other end.
After 4 walks between the lines the 40 meters is divided by the total time in seconds and expressed as meters pr.
second
|
2-3 years after total knee arthroplasty
|
Stair Climb Test (SCT)
Time Frame: 2-3 years after total knee arthroplasty
|
Difference in performance between allocation groups on the stair climb test exercise at follow-up assessed as time in seconds it takes to walk 9 steps up and 9 steps down a flight of stairs.
|
2-3 years after total knee arthroplasty
|
Thigh Force
Time Frame: 2-3 years after total knee arthroplasty
|
Difference in thigh force between allocation groups at follow-up assessed during flexion and extension.
Force will be measured with an EASYFORCE-apparatus and expressed as newton.
|
2-3 years after total knee arthroplasty
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Asger K Mølgaard, MD, Research Center for Anaesthesiology and Intensive Care Medicine, Department of Anaesthesiology, Næstved, Slagelse and Ringsted Hospitals
- Study Chair: Daniel Hägi-Pedersen, MD, Ph.D., Research Center for Anaesthesiology and Intensive Care Medicine, Department of Anaesthesiology, Næstved, Slagelse and Ringsted Hospitals
- Study Chair: Kasper S Gasbjerg, MD, Research Center for Anaesthesiology and Intensive Care Medicine, Department of Anaesthesiology, Næstved, Slagelse and Ringsted Hospitals
- Study Chair: Ole Mathiesen, MD, PhD, Assoc Prof, Centre for Anaesthesiological Research, Department of Anaesthesiology, Zealand University Hospital
- Study Chair: Søren T Skou, PhD, Assoc Prof, PROgrez, Department of physical therapy and Occupational Therapy, Næstved, Slagelse and Ringsted Hospitals
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 15, 2021
Primary Completion (Actual)
June 7, 2022
Study Completion (Actual)
June 8, 2022
Study Registration Dates
First Submitted
November 16, 2021
First Submitted That Met QC Criteria
November 16, 2021
First Posted (Actual)
November 30, 2021
Study Record Updates
Last Update Posted (Actual)
October 6, 2022
Last Update Submitted That Met QC Criteria
October 4, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021-RCAI-ASMAN-st02
- SJ-944 (Other Identifier: Regional Ethics Committee)
- REG-108-2021 (Other Identifier: List of ongoing research in Region Zealand (on behalf of the Danish Data Protection Agency))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
If data are to be published, they will be anonymised according to ICIMEs (International Committee of Medical Journal Editors) guidelines
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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