Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
162 participants
INTERVENTIONAL
2021-12-15
2022-06-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Treatment A
24mg dexamethasone i.v. perioperatively and 24mg dexamethasone i.v. on the first postoperative day
Dexamethasone
24mg dexamethasone
Treatment B
24mg dexamethasone i.v. perioperatively and placebo (isotonic saline) i.v. on the first postoperative day
Dexamethasone
24mg dexamethasone
Isotonic saline
Isotonic saline
Treatment C
Placebo (isotonic saline) i.v. perioperatively and placebo (isotonic saline) i.v. on the first postoperative day
Isotonic saline
Isotonic saline
Interventions
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Dexamethasone
24mg dexamethasone
Isotonic saline
Isotonic saline
Eligibility Criteria
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Inclusion Criteria
* Signed, informed consent for participation
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Slagelse Hospital
OTHER
Responsible Party
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Asger Krog Moelgaard
MD, Ph.D.-student
Principal Investigators
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Asger K Mølgaard, MD
Role: PRINCIPAL_INVESTIGATOR
Research Center for Anaesthesiology and Intensive Care Medicine, Department of Anaesthesiology, Næstved, Slagelse and Ringsted Hospitals
Daniel Hägi-Pedersen, MD, Ph.D.
Role: STUDY_CHAIR
Research Center for Anaesthesiology and Intensive Care Medicine, Department of Anaesthesiology, Næstved, Slagelse and Ringsted Hospitals
Kasper S Gasbjerg, MD
Role: STUDY_CHAIR
Research Center for Anaesthesiology and Intensive Care Medicine, Department of Anaesthesiology, Næstved, Slagelse and Ringsted Hospitals
Ole Mathiesen, MD, PhD, Assoc Prof
Role: STUDY_CHAIR
Centre for Anaesthesiological Research, Department of Anaesthesiology, Zealand University Hospital
Søren T Skou, PhD, Assoc Prof
Role: STUDY_CHAIR
PROgrez, Department of physical therapy and Occupational Therapy, Næstved, Slagelse and Ringsted Hospitals
Locations
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Næstved, Slagelse og Ringsted Hospitals
Næstved, , Denmark
Næstved, Slagelse and Ringsted Hospitals
Slagelse, , Denmark
Countries
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References
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Molgaard AK, Gasbjerg KS, Skou ST, Mathiesen O, Hagi-Pedersen D. Chronic Pain and Functional Outcome 3 years After Total Knee Arthroplasty and Perioperative Dexamethasone: A Follow-Up of the Randomized, Clinical DEX-2-TKA Trial. J Arthroplasty. 2023 Dec;38(12):2592-2598.e2. doi: 10.1016/j.arth.2023.05.060. Epub 2023 Jun 5.
Other Identifiers
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SJ-944
Identifier Type: OTHER
Identifier Source: secondary_id
REG-108-2021
Identifier Type: OTHER
Identifier Source: secondary_id
2021-RCAI-ASMAN-st02
Identifier Type: -
Identifier Source: org_study_id
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