Dexamethasone and Functional Outcome After TKA

NCT ID: NCT05137080

Last Updated: 2022-10-06

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

162 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-15

Study Completion Date

2022-06-08

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Knee Pain Dexamethasone Total Knee Arthroplasty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Treatment A

24mg dexamethasone i.v. perioperatively and 24mg dexamethasone i.v. on the first postoperative day

Group Type ACTIVE_COMPARATOR

Dexamethasone

Intervention Type DRUG

24mg dexamethasone

Treatment B

24mg dexamethasone i.v. perioperatively and placebo (isotonic saline) i.v. on the first postoperative day

Group Type ACTIVE_COMPARATOR

Dexamethasone

Intervention Type DRUG

24mg dexamethasone

Isotonic saline

Intervention Type DRUG

Isotonic saline

Treatment C

Placebo (isotonic saline) i.v. perioperatively and placebo (isotonic saline) i.v. on the first postoperative day

Group Type PLACEBO_COMPARATOR

Isotonic saline

Intervention Type DRUG

Isotonic saline

Interventions

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Dexamethasone

24mg dexamethasone

Intervention Type DRUG

Isotonic saline

Isotonic saline

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Slagelse Hospital

OTHER

Sponsor Role lead

Responsible Party

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Asger Krog Moelgaard

MD, Ph.D.-student

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Næstved, Slagelse and Ringsted Hospitals

Slagelse, , Denmark

Site Status

Countries

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Denmark

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.

Reference Type DERIVED
PMID: 37286048 (View on PubMed)

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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