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Completed

NCT Number: NCT05137080

Dexamethasone and Functional Outcome After TKA

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Næstved, Slagelse og Ringsted Hospitals, Næstved, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexamethasone

Drug

24mg dexamethasone

Isotonic saline

Drug

Isotonic saline

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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. 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.

  3. 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.

  4. 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.

  5. 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

  6. 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.
  7. 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
  8. 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

  9. 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.

  10. 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.

Sponsors and collaborators

Lead sponsor

Slagelse Hospital

Other

Registry information

Official study title

Dexamethasone and Functional Outcome After Total Knee Arthroplasty: A 2 Year Follow up of the DEX-2-TKA-trial

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 30, 2021
Registry last updated
Oct 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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