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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
162

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Denmark
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Treatment A
24mg dexamethasone i.v. perioperatively and 24mg dexamethasone i.v. on the first postoperative day
Drug: Dexamethasone
24mg dexamethasone
Active Comparator: Treatment B
24mg dexamethasone i.v. perioperatively and placebo (isotonic saline) i.v. on the first postoperative day
Drug: Dexamethasone
24mg dexamethasone
Drug: Isotonic saline
Isotonic saline
Placebo Comparator: Treatment C
Placebo (isotonic saline) i.v. perioperatively and placebo (isotonic saline) i.v. on the first postoperative day
Drug: Isotonic saline
Isotonic saline

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Slagelse Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 15, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 7, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 8, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 16, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 16, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 30, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 6, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 4, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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