Dexamethasone and Functional Outcome After TKA

Sponsor
Slagelse Hospital (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05137080
Collaborator
(none)
252
Enrollment
2
Locations
3
Arms
12.5
Anticipated Duration (Months)
126
Patients Per Site
10.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
252 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Dexamethasone and Functional Outcome After Total Knee Arthroplasty: A 2 Year Follow up of the DEX-2-TKA-trial
Actual Study Start Date :
Dec 15, 2021
Anticipated Primary Completion Date :
Jul 1, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

ArmIntervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  1. Average pain during functional performance exercises [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).

Secondary Outcome Measures

  1. EQ-5D-5L [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. Oxford Knee Score [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.

  3. PainDetect [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.

  4. Use of opioids [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.

  5. Range of Motion [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

  6. Timed-Up-To-Go (TUG) [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.

  7. 30 second chair stand test (30CST) [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

  8. 40 meter fast paced walk test (40FPW) [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

  9. Stair Climb Test (SCT) [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.

  10. Thigh Force [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Næstved, Slagelse og Ringsted HospitalsNæstvedDenmark4700
2Næstved, Slagelse and Ringsted HospitalsSlagelseDenmark4200

Sponsors and Collaborators

  • Slagelse Hospital

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 Chair: Kristoffer B Hare, MD, PhD, Department of Orthopedics, Næstved, Slagelse and Ringsted Hospitals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Asger Krog Moelgaard, MD, Ph.D.-student, Slagelse Hospital
ClinicalTrials.gov Identifier:
NCT05137080
Other Study ID Numbers:
  • 2021-RCAI-ASMAN-st02
  • SJ-944
  • REG-108-2021
First Posted:
Nov 30, 2021
Last Update Posted:
Dec 16, 2021
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 16, 2021