| CTRI Number |
CTRI/2020/11/029269 [Registered on: 20/11/2020] Trial Registered Prospectively |
| Last Modified On: |
14/11/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Manual versus Robotic-arm assisted Total Knee Replacement |
|
Scientific Title of Study
|
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 |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Suhas Masilamani |
| Designation |
Consultant Orthopaedic and Joint Replacement Surgeon |
| Affiliation |
Sunshine Hospitals, Gachibowli |
| Address |
Department of Orthopaedics, Sunshine Hospitals, 45, 7-56/19, Survey No. 40 46, Dargah Road LIG Chitrapuri Colony, Prashant Hills, Radhe Nagar, Gachibowli, Rai Durg, Telangana
Hyderabad
TELANGANA
500035
India |
| Phone |
09948958941 |
| Fax |
|
| Email |
drsuhas09@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Suhas Masilamani |
| Designation |
Consultant Orthopaedic and Joint Replacement Surgeon |
| Affiliation |
Sunshine Hospitals, Gachibowli |
| Address |
Department of Orthopaedics, Sunshine Hospitals, 45, 7-56/19, Survey No. 40 46, Dargah Road LIG Chitrapuri Colony, Prashant Hills, Radhe Nagar, Gachibowli, Rai Durg, Telangana
Hyderabad
TELANGANA
500035
India |
| Phone |
09948958941 |
| Fax |
|
| Email |
drsuhas09@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Suhas Masilamani |
| Designation |
Consultant Orthopaedic and Joint Replacement Surgeon |
| Affiliation |
Sunshine Hospitals, Gachibowli |
| Address |
Department of Orthopaedics, Sunshine Hospitals, 45, 7-56/19, Survey No. 40 46, Dargah Road LIG Chitrapuri Colony, Prashant Hills, Radhe Nagar, Gachibowli, Rai Durg, Telangana
Hyderabad
TELANGANA
500035
India |
| Phone |
09948958941 |
| Fax |
|
| Email |
drsuhas09@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sunshine Hospitals, Gachibowli, Hyderabad, Telangana, 500035 |
|
|
Primary Sponsor
|
| Name |
Sunshine Hospitals Gachibowli |
| Address |
Department of Orthopaedics, Sunshine Hospitals, 45, 7-56/19, Survey No. 40 46, Dargah Road LIG Chitrapuri Colony, Prashant Hills, Radhe Nagar, Gachibowli, Rai Durg, Telangana |
| Type of Sponsor |
Private hospital/clinic |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Pankaj Rane |
Sunshine Hospitals, Gachibowli |
Department of Orthopaedics, Sunshine Hospitals, 45, 7-56/19, Survey No. 40 46, Dargah Road LIG Chitrapuri Colony, Prashant Hills, Radhe Nagar, Gachibowli, Rai Durg, Telangana, 500035
Hyderabad
TELANGANA |
08220937946
ranepankaj85@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sunshine Institutional Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M170||Bilateral primary osteoarthritis of knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Manual or Jig-Based TKA |
Patients undergoing simultaneous bilateral total knee replacement surgery, will be RANDOMIZED to receive Robot-arm assisted TKR one side/knee and conventional/manual TKR on the other knee.
The patient will be consented for the same, and will not have any financial implications due to use of robotics for one side that receives robotic-arm assisted TKR |
| Intervention |
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 side/knee and conventional/manual TKR on the other knee. |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
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) |
|
| ExclusionCriteria |
| Details |
Inflammatory arthropathy
Asymmetrical knee deformities
Differential stage of arthritis of the knee in the same patient
previous surgery on the knee |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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
|
| Outcome |
TimePoints |
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) |
6,12,18,24,48 hours after surgery |
| Knee Range of Motion (ROM) Passive ROM of each knee measured in degrees |
24, 48 hours after surgery |
| 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 |
| Distance walked in 3 minutes (in meters) |
24, 48 hours after surgery |
| WOMAC Score |
1,3,6,12 months |
| Oxford Knee Score (OKS) |
1,3,6,12 months |
| Forgotten Joint Score (FJS) |
1,3,6,12 months |
| EQ-5D score |
1,3,6,12 months |
| Knee Society Score |
1,3,6,12 months |
| Limb alignment: CT based measurement of Hip-Knee-Ankle angle measurement in degrees |
Immediately Post-operative |
|
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Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/12/2020 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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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.
|