Manual versus Robotic-arm assisted Total Knee Replacement

Not yet recruiting

Conditions: Bilateral primary osteoarthritis of knee,

Registration Number: CTRI/2020/11/029269

Lead Sponsor: Sunshine Hospitals Gachibowli

Brief Summary: Total Knee Arthroplasty (TKA) is the most successful procedure for the treatment of knee arthritis, providing consistent pain relief and return to activity after surgery. After several decades of surgical refinement and research, it is commonly accepted that one of the important factors influencing outcomes after TKA is the limb alignment and proper positioning of implants. Compared to conventional or manual jig-based TKR, Robot-arm assisted TKA has been proven to significantly improve accuracy of component positioning and to meet alignment targets reliably and reproducibly.

With robot-arm assisted TKR, the bone cuts are planned and controlled down to a millimeter. The saw blade excursion into bone and surrounding soft-tissues is highly controlled and restricted to a pre-determined area by haptic technology. These factors help in reducing soft-tissue insults of surgery. Since surgeons do not have to place jigs, the soft tissue dissection for exposure is also minimised.

There are multiple confounding factors in the assessment and comparison of robotic-arm versus manual TKR between patients like- grade of arthritis, severity of deformity, pain subjectivity, weight and BMI of patients etc. This is the basis behind our methodology of performing Robotic-arm assisted TKA (RATKA) and conventional TKA in the same patient undergoing bilateral TKA in the same sitting, without any added financial implications for the patient.

We hypothesize that robot-arm assisted TKR is associated with reduced pain, faster rehabilitation and better functional outcomes compared to manual or conventional TKR.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 100

Inclusion Criteria

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.
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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Visual Analogue Scale for Pain (VAS Pain) for assessment of post-operative pain, scored for each knee separately	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 Outcome Measures

Name	Time	Method
Additional Analgesic requirements calculated by	1. Number of doses of intravenous Fentanyl or SC Morphine, Intravenous tramadol
Knee Range of Motion (ROM) Active ROM of each knee measured in degrees	24,48 hours
Use of aids to walk (eg. 4-frame walker, crutches, single-cane, unaided)	24, 48 hours after surgery
Forgotten Joint Score (FJS)	1,3,6,12 months
Knee Range of Motion (ROM) Passive ROM of each knee measured in degrees	24, 48 hours after surgery
EQ-5D score	1,3,6,12 months
Knee Society Score	1,3,6,12 months
Distance walked in 3 minutes (in meters)	24, 48 hours after surgery
Oxford Knee Score (OKS)	1,3,6,12 months
WOMAC Score	1,3,6,12 months
Limb alignment: CT based measurement of Hip-Knee-Ankle angle measurement in degrees	Immediately Post-operative

Trial Locations

Locations (1): Sunshine Hospitals, Gachibowli
🇮🇳
Hyderabad, TELANGANA, India
Sunshine Hospitals, Gachibowli
🇮🇳Hyderabad, TELANGANA, India
Dr Pankaj Rane
Principal investigator
08220937946
ranepankaj85@gmail.com