Dexamethasone and Functional Outcome After TKA

Total Knee Arthroplasty Clinical Trial

Official title:

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

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
• 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
• 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

Related Conditions & MeSH terms

• Chronic Knee Pain
• Dexamethasone
• Total Knee Arthroplasty

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