Clinical trial NCT05137080: Dexamethasone and Functional Outcome After TKA
Official title: Dexamethasone and Functional Outcome After Total Knee Arthroplasty: A 2 Year Follow up of the DEX-2-TKA-trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Knee Pain
Dexamethasone
Total Knee Arthroplasty
Lead sponsor: Slagelse Hospital
Sponsor class: OTHER
First posted: 2021-11-30
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Average pain during functional performance exercises
timeFrame: 2-3 years after total knee arthroplasty
Secondary outcomes:
measure: EQ-5D-5L
timeFrame: 2-3 years after total knee arthroplasty
measure: Oxford Knee Score
timeFrame: 2-3 years after total knee arthroplasty
measure: PainDetect
timeFrame: 2-3 years after total knee arthroplasty
measure: Use of opioids
timeFrame: 2-3 years after total knee arthroplasty
measure: Range of Motion
timeFrame: 2-3 years after total knee arthroplasty
measure: Timed-Up-To-Go (TUG)
timeFrame: 2-3 years after total knee arthroplasty
measure: 30 second chair stand test (30CST)
timeFrame: 2-3 years after total knee arthroplasty
measure: 40 meter fast paced walk test (40FPW)
timeFrame: 2-3 years after total knee arthroplasty
measure: Stair Climb Test (SCT)
timeFrame: 2-3 years after total knee arthroplasty
measure: Thigh Force
timeFrame: 2-3 years after total knee arthroplasty
Other outcomes:
Locations:
city: Næstved
country: Denmark
facility: Næstved, Slagelse og Ringsted Hospitals
city: Slagelse
country: Denmark
facility: Næstved, Slagelse and Ringsted Hospitals
Study officials:
affiliation: Research Center for Anaesthesiology and Intensive Care Medicine, Department of Anaesthesiology, Næstved, Slagelse and Ringsted Hospitals
name: Asger K Mølgaard, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Research Center for Anaesthesiology and Intensive Care Medicine, Department of Anaesthesiology, Næstved, Slagelse and Ringsted Hospitals
name: Daniel Hägi-Pedersen, MD, Ph.D.
role: STUDY_CHAIR
affiliation: Research Center for Anaesthesiology and Intensive Care Medicine, Department of Anaesthesiology, Næstved, Slagelse and Ringsted Hospitals
name: Kasper S Gasbjerg, MD
role: STUDY_CHAIR
affiliation: Centre for Anaesthesiological Research, Department of Anaesthesiology, Zealand University Hospital
name: Ole Mathiesen, MD, PhD, Assoc Prof
role: STUDY_CHAIR
affiliation: PROgrez, Department of physical therapy and Occupational Therapy, Næstved, Slagelse and Ringsted Hospitals
name: Søren T Skou, PhD, Assoc Prof
role: STUDY_CHAIR
References: