CTRI/2020/11/029018 [Registered on: 10/11/2020] Trial Registered Prospectively
Last Modified On:
15/03/2023
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Surgical/Anesthesia
Study Design
Randomized, Parallel Group Trial
Public Title of Study
Assessment of outcomes after robot-arm assisted total knee replacement
Scientific Title of Study
Comparison of post-operative pain and early rehabilitation functional vs mechanical alignment in bilateral robotic-arm assisted total knee arthroplasty
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
NIL
NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Praharsha Mulpur
Designation
Senior Registrar
Affiliation
Sunshine Hospitals, Gachibowli
Address
Room Number 133, Department of Orthopaedics, Sunshine Hospital, 45, 7-56/19, Survey No. 40 46, Dargah Road LIG Chitrapuri Colony, Gachibowli, Rai Durg, Telangana Room Number 133, Department of Orthopaedics, Sunshine Hospital, 45, 7-56/19, Survey No. 40 46, Dargah Road LIG Chitrapuri Colony, Gachibowli, Rai Durg, Telangana Hyderabad TELANGANA 500035 India
Phone
09652111991
Fax
Email
praharshamulpur9@gmail.com
Details of Contact Person Scientific Query
Name
Praharsha Mulpur
Designation
Senior Registrar
Affiliation
Sunshine Hospitals, Gachibowli
Address
Room Number 133, Department of Orthopaedics, Sunshine Hospital, 45, 7-56/19, Survey No. 40 46, Dargah Road LIG Chitrapuri Colony, Gachibowli, Rai Durg, Telangana Room Number 133, Department of Orthopaedics, Sunshine Hospital, 45, 7-56/19, Survey No. 40 46, Dargah Road LIG Chitrapuri Colony, Gachibowli, Rai Durg, Telangana Hyderabad TELANGANA 500035 India
Phone
09652111991
Fax
Email
praharshamulpur9@gmail.com
Details of Contact Person Public Query
Name
Praharsha Mulpur
Designation
Senior Registrar
Affiliation
Sunshine Hospitals, Gachibowli
Address
Room Number 133, Department of Orthopaedics, Sunshine Hospital, 45, 7-56/19, Survey No. 40 46, Dargah Road LIG Chitrapuri Colony, Gachibowli, Rai Durg, Telangana Room Number 133, Department of Orthopaedics, Sunshine Hospital, 45, 7-56/19, Survey No. 40 46, Dargah Road LIG Chitrapuri Colony, Gachibowli, Rai Durg, Telangana Hyderabad TELANGANA 500035 India
Phone
09652111991
Fax
Email
praharshamulpur9@gmail.com
Source of Monetary or Material Support
Sunshine Hospital, Gachibowli
Primary Sponsor
Name
Sunshine Hospitals Gachibowli
Address
Department of Orthopaedics, 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
Name
Address
NIL
NIL
Countries of Recruitment
India
Sites of Study
No of Sites = 1
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr Abhishek Gupta
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 Hyderabad TELANGANA
09652111991
abhishekgupta0587@gmail.com
Details of Ethics Committee
No of Ethics Committees= 1
Name of Committee
Approval Status
Sunshine Institutional Ethics Committee
Approved
Regulatory Clearance Status from DCGI
Status
Not Applicable
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition: M170||Bilateral primary osteoarthritis of knee,
Intervention / Comparator Agent
Type
Name
Details
Intervention
Functional Alignment
Patient undergoing simultaneous bilateral total knee arthroplasty will be RANDOMIZED to receive Robotic-arm assisted total knee arthroplasty with random allocation of FUNCTIONAL ALIGNMENT TO ONE KNEE and MECHANICAL ALIGNMENT to the second knee in the same patient
The patient will receive different alignment strategies in the same surgery, which is randomized. There is no separate comparator group. Both alignment strategies will be assessed in the same patient.
Comparator Agent
Mechanical Alignment
Patient undergoing simultaneous bilateral total knee arthroplasty will be RANDOMIZED to receive Robotic-arm assisted total knee arthroplasty with random allocation of FUNCTIONAL ALIGNMENT TO ONE KNEE and MECHANICAL ALIGNMENT to the second knee in the same patient The patient will receive different alignment strategies in the same surgery, which is randomized. There is no separate comparator group. Both alignment strategies will be assessed in the same patient.
Inclusion Criteria
Age From
18.00 Year(s)
Age To
85.00 Year(s)
Gender
Both
Details
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)
ExclusionCriteria
Details
Post-traumatic arthritis
Asymmetrical knee deformities
Unwilling to participate in the trial
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Centralized
Blinding/Masking
Participant, Investigator and Outcome Assessor Blinded
Primary Outcome
Outcome
TimePoints
Pain assessment using the Visual Analogue Pain Scale (VAS Pain), recorded for each knee separately
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 Outcome
Outcome
TimePoints
Analgesic requirements for breakthrough pain after surgery by documentation of requirements of Intravenous Fentanyl OR Subcutaneous Morphine
6 hours, 12 hours, 18 hours, 24 hours, 36 hours and 48 hours after surgery
Knee Range of Motion (ROM) Passive (measured in degrees)
24 hours, 48 hours after surgery
Knee Range of Motion (ROM) Active ROM measured in degrees
24 hours, 48 hours after surgery
Distance walked in 3 minutes. Measured in metres
24 hours, 48 hours after surgery
Aids used to walk indepedently (4-Frame walker, crutch, single cane, unaided walking)
24 hours, 48 hours after surgery
WOMAC (Western Ontario and McMaster Universities Arthritis Index) score
1 month, 3 months, 6 months, 1 year
Knee Society Score (KSS)
1,3,6 MONTHS and 1 year after surgery
EuroQol-5D quality of life measurement (EQ-5D)
1,3,6 MONTHS and 1-year after surgery
Oxford Knee Score (OKS)
1,3,6 and 12 months after surgery
Forgotten Joint Score (FJS)
1,3,6 and 12 months after surgery
Operating time (minutes)
Immediately after surgery
Complications: assessment and documentation
24, 48 hours after surgery
1,3,6 and 12 months after surgery
Limb Alignment (Overall limb alignment measured in degrees of varus or valgus)- CT scan based measurements of the Hip-Knee-Ankle (HKA) angle
Pre-operatively and immediate post-operatively
Target Sample Size
Total Sample Size="100" Sample Size from India="100" Final Enrollment numbers achieved (Total)= "0" Final Enrollment numbers achieved (India)="90"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Brief Summary
Total knee arthroplasty is a time-tested and successful surgery for arthritis of the knee joint. However, despite advances in implant design and refinement of surgical techniques, 20% of patients are still dissatisfied. The overall complication rate is less than 1%. There are many factors which may be responsible for patient dissatisfaction, but one of the common complaints is the patient feels "his/her knee does not feel like the native knee". This could be due to alteration in knee kinematics, resulting in dissatisfaction.
In manual or conventional-Jig based TKR, the target limb alignment is a joint line that is 90 degrees or perpendicular to the mechanical axis of the lower limb. This technique is also known as MECHANICAL ALIGNMENT. Mechanically aligned knees have good survivorship but may compromise the kinematics of the knee leading to pain and reduced function.
Functional alignment is an alternative alignment strategy in which surgeons attempt to restore the pre-operative knee kinematics by placing components to target an joint line that is a few degrees oblique (varus or valgus) to the mechanical axis of the knee, thus restoring the original balance of the knee. This is particularly important in those patients with "constitutional varus" of the knee, where the limb alignment was 1+ degrees of varus. Putting these knees in mechanical alignment (0 degrees) disrupts knee kinematics.
Functional alignment is possible and accurate with robotic-arm assisted TKR, in which the surgeon can visualise every bone cut which is pre-planned. Components are placed in a safe-zone to recreate the balance of the knee, without excessive soft-tissue releases.
The hypothesis of our study is that functional alignment is associated with less soft tissue releases, less dissection, and improved knee kinematics leading to reduced pain, improved early rehabilitation after the surgery.
A lot of confounding factors come into play when trying to compare FUNCTIONAL versus MECHANICAL alignment in different individuals. This is because of differences in the native limb or pre-arthritic limb alignment, OA wear patterns, weight and BMI of the patients etc. This is the reason behind this novel methodology, where patients undergoing bilateral simultaneous TKR will receive two globally accepted and time tested alignment strategies. One knee is randomized to receive functional alignment and the other knee is mechanically aligned. Both strategies are followed widely across the world. The patients thus provide internal controls against which the comparison can be done, without any confounding variables influencing the outcomes.