Dexamethasone and Functional Outcome After TKA

NCT05137080 | Completed Phase 4

• 3 other identifiers: 2021-RCAI-ASMAN-st02SJ-944REG-108-2021
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Chronic Knee Pain; Dexamethasone; Total Knee Arthroplasty

Outcome Measures

Primary Outcomes (1)

• Average pain during functional performance exercises

  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 Outcomes (10)

• EQ-5D-5L

  2-3 years after total knee arthroplasty

• Oxford Knee Score

  2-3 years after total knee arthroplasty

• PainDetect

  2-3 years after total knee arthroplasty

• Use of opioids

  2-3 years after total knee arthroplasty

• Range of Motion

  2-3 years after total knee arthroplasty

Study Arms (3)

Treatment A

ACTIVE COMPARATOR

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

Drug: Dexamethasone

Treatment B

ACTIVE COMPARATOR

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

Drug: Dexamethasone; Drug: Isotonic saline

Treatment C

PLACEBO COMPARATOR

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

Drug: Isotonic saline

Interventions

Dexamethasone DRUG

24mg dexamethasone

Treatment A; Treatment B

Isotonic saline DRUG

Isotonic saline

Treatment B; Treatment C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• participation in the DEX-2-TKA-trial at Næstved Hospital in accordance with protocol
• Signed, informed consent for participation

You may not qualify if:

• Lack of signed, informed consent

Sponsors & Collaborators

• Slagelse Hospital: lead

Study Sites (2)

Næstved, Slagelse og Ringsted Hospitals

Næstved, 4700, Denmark

Location

Næstved, Slagelse and Ringsted Hospitals

Slagelse, 4200, Denmark

Location

Related Publications (1)

• 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.

  PMID: 37286048 DERIVED

MeSH Terms

Interventions

Dexamethasone; Sodium Chloride

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Asger K Mølgaard, MD

  Research Center for Anaesthesiology and Intensive Care Medicine, Department of Anaesthesiology, Næstved, Slagelse and Ringsted Hospitals

  PRINCIPAL INVESTIGATOR

• 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 CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Ph.D.-student

Study Record Dates

• First Submitted: November 16, 2021
• First Posted: November 30, 2021
• Study Start: December 15, 2021
• Primary Completion: June 7, 2022
• Study Completion: June 8, 2022
• Last Updated: October 6, 2022

Record last verified: 2022-10

Locations

DK (2)