Dexamethasone and Functional Outcome After TKA

Slagelse Hospital

Status and phase: Completed; Phase 4

Conditions: Chronic Knee Pain; Total Knee Arthroplasty; Dexamethasone

Treatments: Drug: Isotonic saline; Drug: Dexamethasone

Study type: Interventional

Funder types: Other

Identifiers

NCT05137080

2021-RCAI-ASMAN-st02

SJ-944 (Other Identifier)

REG-108-2021 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 162 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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162 participants in 3 patient groups, including a placebo group

Treatment A

Active Comparator group

Description:

24mg dexamethasone i.v. perioperatively and 24mg dexamethasone i.v. on the first postoperative day

Treatment:

Drug: Dexamethasone

Treatment B

Active Comparator group

Description:

24mg dexamethasone i.v. perioperatively and placebo (isotonic saline) i.v. on the first postoperative day

Treatment:

Drug: Isotonic saline

Drug: Dexamethasone

Treatment C

Placebo Comparator group

Description:

Placebo (isotonic saline) i.v. perioperatively and placebo (isotonic saline) i.v. on the first postoperative day

Treatment:

Drug: Isotonic saline