Health Condition 1: M170- Bilateral primary osteoarthritis of knee
Conditions
Interventions
Intervention1: Functional Alignment: Patient undergoing simultaneous bilateral total knee arthroplasty will be RANDOMIZED to receive Robotic-arm assisted total knee arthroplasty with random allocation
Sponsors
Sunshine Hospitals Gachibowli
Eligibility
Inclusion criteria
Inclusion criteria: All patients eligible for Bilateral simultaneous total knee arthroplasty for primary OA of the knee joint These patients are consented for participation in this RCT, in which they will receive robotic-arm assisted total knee replacement surgery with different alignment strategies in both the knees (i.e one knee randomized to receive TKR with FUNCTIONAL ALIGNMENT, and the second knee to receive TKR with MECHANICAL ALIGNMENT)
Exclusion criteria
Exclusion criteria: Post-traumatic arthritis Asymmetrical knee deformities Unwilling to participate in the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain assessment using the Visual Analogue Pain Scale (VAS Pain), recorded for each knee separatelyTimepoint: Pain assessment using the Visual Analogue Pain Scale (VAS Pain), recorded for each knee separately at 6 hours, 12 hours, 18 hours, 24 hours, 36 hours and 48 hours after surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| Aids used to walk indepedently (4-Frame walker, crutch, single cane, unaided walking)Timepoint: 24 hours, 48 hours after surgery;Analgesic requirements for breakthrough pain after surgery by documentation of requirements of Intravenous Fentanyl OR Subcutaneous MorphineTimepoint: 6 hours, 12 hours, 18 hours, 24 hours, 36 hours and 48 hours after surgery;Complications: assessment and documentationTimepoint: 24, 48 hours after surgery 1,3,6 and 12 months after surgery;Distance walked in 3 minutes. Measured in metresTimepoint: 24 hours, 48 hours after surgery;EuroQol-5D quality of life measurement (EQ-5D)Timepoint: 1,3,6 MONTHS and 1-year after surgery;Forgotten Joint Score (FJS)Timepoint: 1,3,6 and 12 months after surgery;Knee Range of Motion (ROM) Active ROM measured in degreesTimepoint: 24 hours, 48 hours after surgery;Knee Range of Motion (ROM) Passive (measured in degrees)Timepoint: 24 hours, 48 hours after surgery;Knee Society Score (KSS)Timepoint: 1,3,6 MONTHS and 1 year after surgery;Limb Alignment (Overall limb alignment measured in degrees of varus or valgus)- CT scan based measurements of the Hip-Knee-Ankle (HKA) angleTimepoint: Pre-operatively and immediate post-operatively;Operating time (minutes)Timepoint: Immediately after surgery;Oxford Knee Score (OKS)Timepoint: 1,3,6 and 12 months after surgery;WOMAC (Western Ontario and McMaster Universities Arthritis Index) scoreTimepoint: 1 month, 3 months, 6 months, 1 year | — |
Countries
India
Contacts
Public ContactPraharsha Mulpur
Sunshine Hospitals, Gachibowli
Outcome results
None listed