A Comparison of 6 month Post operative Patient Reported Outcome and Adverse Events after Unicompartmental Knee Arthroplasty vs Total Knee Arthroplasty in elderly patients with age more than equal to 70 years : A Randomised Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Functional Outcome:
研究概览
简要总结
The aim of this study is to compare 6-month postoperative patient reported outcome measures (PROM) and post operative adverse events (POAE) after unicompartmental knee arthroplasty(UKA) versus total knee arthroplasty(TKA) in age more than equal to 70 years.
OBJECTIVES:
- PRIMARY OBJECTIVE:
- To compare 6-month PROM and POAE in patients undergoing UKA versus TKA
-
SECONDARY OBJECTIVE:
-
To determine implant positioning between both groups
-
To determine survivorship with Kaplan Meier chart (Resurgery)
MATERIALS AND METHODS: This will be randomized controlled trial. The study will be executed in the department of Orthopedics at All India Institute of Medical Science, Jodhpur for a period of 2 years.
STUDY DESIGN: A double blinded non inferiority randomized controlled trial
SAMPLING SIZE:
Where is standard deviation
Zα2 is the standard normal z-value for a significance level α = 0.05, which is 1.196.
Zβ is the standard normal z-value for the power of 80%, which is 0.84.
μ1-μ2 –is the difference in mean values of the 2 groups
The sample size calculated according to above formula using study by Boonchana et.al was 60 (30 in each group).
NULL HYPOTHESIS – There is similar PROM and POAE between UKA and TKA.
ALTERNATE HYPOTHESIS- There is dissimilar PROM and POAE between UKA and TKA
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 70.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •More than equal to 70 years old patients Antero Medial compartment varus osteoarthritis of knee Flexion more than 90 degrees Flexion contracture less than 10 degrees Varus deformity less than 20 degrees.
排除标准
- •Grade II-IV degenerative changes of lateral compartment H/O Lateral meniscectomy Anterior cruciate ligament absence BMI more than 40 Kg/m2.
结局指标
主要结局
Functional Outcome:
时间窗: Functional Outcome: | a) Baseline | b)1 week | c)12 week | d) 24 week
a) 2 minute walk test
时间窗: Functional Outcome: | a) Baseline | b)1 week | c)12 week | d) 24 week
b) KOOS score
时间窗: Functional Outcome: | a) Baseline | b)1 week | c)12 week | d) 24 week
c) KSS 2011 score
时间窗: Functional Outcome: | a) Baseline | b)1 week | c)12 week | d) 24 week
d) FJS (Forgotten joint score)
时间窗: Functional Outcome: | a) Baseline | b)1 week | c)12 week | d) 24 week
次要结局
- To determine implant positioning between both groups(To determine survivorship with Kaplan Meier chart (Resurgery))
研究者
Dr Aryan Mechu
AIIMS JODHPUR