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Manual versus Robotic-arm assisted Total Knee Replacement

Comparison of post-operative pain, early rehabilitation and functional outcomes of robotic-arm assisted total knee arthroplasty (TKA) versus conventional TKA in bilateral simultaneous TKA a prospective double blinded randomised controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/11/029269
Enrollment
100
Registered
2020-11-20
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: M170- Bilateral primary osteoarthritis of knee

Interventions

Intervention1: Robotic-Arm Assisted Total Knee Arthroplasty (RATKA): Patients undergoing simultaneous bilateral total knee replacement surgery, will be RANDOMIZED to receive Robot-arm assisted TKR one

Sponsors

Sunshine Hospitals Gachibowli
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients with bilateral primary osteoarthritis of the knee 2. Both knees with symmetrical deformities (varus or valgus) 3. Radiologically same stage of OA Knee as per the Kellgren-Lawrence grading system. 4. Patients who consent to undergo simultaneous bilateral TKR, And to receive manual/conventional jig-based TKR on one side and Robot-arm assisted TKR on the other side (as decided by computer generated randomization)

Exclusion criteria

Exclusion criteria: Inflammatory arthropathy Asymmetrical knee deformities Differential stage of arthritis of the knee in the same patient previous surgery on the knee

Design outcomes

Primary

MeasureTime frame
Visual Analogue Scale for Pain (VAS Pain) for assessment of post-operative pain, scored for each knee separatelyTimepoint: Visual Analogue Scale for Pain (VAS Pain) for assessment of post-operative pain 6,12,18,24,36,48 hours after surgery 1,3,6,12 months after surgery—

Secondary

MeasureTime frame
Additional Analgesic requirements calculated by 1. Number of doses of intravenous Fentanyl or SC Morphine, Intravenous tramadol For breakthrough pain 2. Calculation of Morphine-Equivalents (ME)Timepoint: 6,12,18,24,48 hours after surgery;Distance walked in 3 minutes (in meters)Timepoint: 24, 48 hours after surgery;EQ-5D scoreTimepoint: 1,3,6,12 months;Forgotten Joint Score (FJS)Timepoint: 1,3,6,12 months;Knee Range of Motion (ROM) Active ROM of each knee measured in degreesTimepoint: 24,48 hours;Knee Range of Motion (ROM) Passive ROM of each knee measured in degreesTimepoint: 24, 48 hours after surgery;Knee Society ScoreTimepoint: 1,3,6,12 months;Limb alignment: CT based measurement of Hip-Knee-Ankle angle measurement in degreesTimepoint: Immediately Post-operative;Oxford Knee Score (OKS)Timepoint: 1,3,6,12 months;Use of aids to walk (eg. 4-frame walker, crutches, single-cane, unaided)Timepoint: 24, 48 hours after surgery;WOMAC ScoreTimepoint: 1,3,6,12 months—

Countries

India

Contacts

Public ContactSuhas Masilamani

Sunshine Hospitals, Gachibowli

drsuhas09@gmail.com09948958941

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026