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
Overview
- Phase
- Phase 4
- Status
- Not yet recruiting
- Sponsor
- AIIMS Jodhpur
- Enrollment
- 52
- Locations
- 1
- Primary Endpoint
- Functional Outcome:
Overview
Brief Summary
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 70.00 Year(s) to 99.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •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.
Exclusion Criteria
- •Grade II-IV degenerative changes of lateral compartment H/O Lateral meniscectomy Anterior cruciate ligament absence BMI more than 40 Kg/m2.
Outcomes
Primary Outcomes
Functional Outcome:
Time Frame: Functional Outcome: | a) Baseline | b)1 week | c)12 week | d) 24 week
a) 2 minute walk test
Time Frame: Functional Outcome: | a) Baseline | b)1 week | c)12 week | d) 24 week
b) KOOS score
Time Frame: Functional Outcome: | a) Baseline | b)1 week | c)12 week | d) 24 week
c) KSS 2011 score
Time Frame: Functional Outcome: | a) Baseline | b)1 week | c)12 week | d) 24 week
d) FJS (Forgotten joint score)
Time Frame: Functional Outcome: | a) Baseline | b)1 week | c)12 week | d) 24 week
Secondary Outcomes
- To determine implant positioning between both groups(To determine survivorship with Kaplan Meier chart (Resurgery))
Investigators
Dr Aryan Mechu
AIIMS JODHPUR