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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05137080
Other study ID # 2021-RCAI-ASMAN-st02
Secondary ID SJ-944REG-108-20
Status Completed
Phase Phase 4
First received
Last updated
Start date December 15, 2021
Est. completion date June 8, 2022

Study information

Verified date October 2022
Source Slagelse Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 162
Est. completion date June 8, 2022
Est. primary completion date June 7, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Dexamethasone
24mg dexamethasone
Isotonic saline
Isotonic saline

Locations

Country Name City State
Denmark Næstved, Slagelse og Ringsted Hospitals Næstved
Denmark Næstved, Slagelse and Ringsted Hospitals Slagelse

Sponsors (1)

Lead Sponsor Collaborator
Slagelse Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 EQ-5D-5L 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. 2-3 years after total knee arthroplasty
Secondary Oxford Knee Score 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. 2-3 years after total knee arthroplasty
Secondary PainDetect 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. 2-3 years after total knee arthroplasty
Secondary Use of opioids Difference in daily use of opioids between allocation groups at follow-up. Daily use will be calculated into equivalents of mg morphine per day. 2-3 years after total knee arthroplasty
Secondary Range of Motion 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 2-3 years after total knee arthroplasty
Secondary Timed-Up-To-Go (TUG) 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.
2-3 years after total knee arthroplasty
Secondary 30 second chair stand test (30CST) 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
2-3 years after total knee arthroplasty
Secondary 40 meter fast paced walk test (40FPW) 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 2-3 years after total knee arthroplasty
Secondary Stair Climb Test (SCT) 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. 2-3 years after total knee arthroplasty
Secondary Thigh Force 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. 2-3 years after total knee arthroplasty
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