Dexamethasone and Functional Outcome After Total Knee Arthroplasty: A 2 Year Follow up of the DEX-2-TKA-trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 162
- 试验地点
- 2
- 主要终点
- Average pain during functional performance exercises
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •participation in the DEX-2-TKA-trial at Næstved Hospital in accordance with protocol
- •Signed, informed consent for participation
排除标准
- •Lack of signed, informed consent
研究组 & 干预措施
Treatment A
24mg dexamethasone i.v. perioperatively and 24mg dexamethasone i.v. on the first postoperative day
干预措施: Dexamethasone (Drug)
Treatment B
24mg dexamethasone i.v. perioperatively and placebo (isotonic saline) i.v. on the first postoperative day
干预措施: Dexamethasone (Drug)
Treatment B
24mg dexamethasone i.v. perioperatively and placebo (isotonic saline) i.v. on the first postoperative day
干预措施: Isotonic saline (Drug)
Treatment C
Placebo (isotonic saline) i.v. perioperatively and placebo (isotonic saline) i.v. on the first postoperative day
干预措施: Isotonic saline (Drug)
结局指标
主要结局
Average pain during functional performance exercises
时间窗: 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).
次要结局
- Use of opioids(2-3 years after total knee arthroplasty)
- Range of Motion(2-3 years after total knee arthroplasty)
- Thigh Force(2-3 years after total knee arthroplasty)
- Timed-Up-To-Go (TUG)(2-3 years after total knee arthroplasty)
- Stair Climb Test (SCT)(2-3 years after total knee arthroplasty)
- EQ-5D-5L(2-3 years after total knee arthroplasty)
- Oxford Knee Score(2-3 years after total knee arthroplasty)
- PainDetect(2-3 years after total knee arthroplasty)
- 30 second chair stand test (30CST)(2-3 years after total knee arthroplasty)
- 40 meter fast paced walk test (40FPW)(2-3 years after total knee arthroplasty)
研究者
Asger Krog Moelgaard
MD, Ph.D.-student
Slagelse Hospital