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

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

      • Næstved, Denmark, 4700
        • Næstved, Slagelse og Ringsted Hospitals
      • 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

  • Stand up from the chair
  • Walk to a line on the floor 3 meters away
  • Turn
  • Walk back to the chair
  • Sit down again. The time will be measured from "Go" to the participant is sitting again.
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

  • sitting on a chair with the arms crossed across the chest
  • stand fully up
  • sit down again
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.

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

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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