| CTRI Number |
CTRI/2022/07/043767 [Registered on: 06/07/2022] Trial Registered Prospectively |
| Last Modified On: |
05/07/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to check the correctness of bone cuts and rotation of tibia in patients undergoing robot assisted total knee replacement |
|
Scientific Title of Study
|
Prospective study to evaluate the accuracy of bone resection of MAKO TKA and measurement of tibial component rotation CT based with short term functional outcome. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 2022/06/MTKA/AIOR |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shashank Varma |
| Designation |
DNB student |
| Affiliation |
Anup Institute of Orthopedics and Rehabilitation |
| Address |
Anup Institute of Orthopaedics and Rehabilitation, G75-77, P C Colony, Kankerbagh, Patna-800020
Patna
BIHAR
800020
India |
| Phone |
8800547149 |
| Fax |
|
| Email |
drshashankvarma04@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashish Singh |
| Designation |
Consultant Orthopedic Surgeon and Director |
| Affiliation |
Anup Institute of Orthopedics and Rehabilitation |
| Address |
Anup Institute of Orthopaedics and Rehabilitation, G75-77, P C Colony, Kankerbagh, Patna-800020
Patna
BIHAR
800020
India |
| Phone |
8294240349 |
| Fax |
|
| Email |
drashishsingh@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashish Singh |
| Designation |
Consultant Orthopedic Surgeon and Director |
| Affiliation |
Anup Institute of Orthopedics and Rehabilitation |
| Address |
Anup Institute of Orthopaedics and Rehabilitation, G75-77, P C Colony, Kankerbagh, Patna-800020
Patna
BIHAR
800020
India |
| Phone |
8294240349 |
| Fax |
|
| Email |
drashishsingh@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Anup Institute of Orthopedics and Rehabilitation |
|
|
Primary Sponsor
|
| Name |
Anup Institute of Orthopedics and Rehabilitation |
| Address |
Anup institute of Orthopaedics and Rehabilitation, G75-77, P C Colony, Kankerbagh, Patna-800020 |
| Type of Sponsor |
Private hospital/clinic |
|
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Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shashank Varma |
Anup Institute of Orthopedics and Rehabilitation |
R. No. 117, Ground Floor, AIOR OPD Complex, G75-77, P C Colony, Kankerbagh, Patna-800020
Patna
BIHAR |
8800547149
drshashankvarma04@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of AIOR |
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: M255||Pain in joint, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
None |
Not Applicable |
| Intervention |
None |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
1. All primary Osteoarthritis (OA) knee, Rheumatoid arthritis (RA) knee / Post-Traumatic Osteoarthritis undergoing Single implant – Stryker triathlon using MAKO Robotic system
2. Male and females aged 21 years to 85 years (inclusive)
3. Subject is willing to take part in the study by signing Ethics Committee (EC) approved informed consent form (ICF)
4. Subject agrees to comply with postoperative scheduled clinical and radiographic evaluation
|
|
| ExclusionCriteria |
| Details |
1. Revision TKA
2. Using constraint knee
3. Knee with tumours, infection
4. Patients shall be excluded from the study if their data is not captured by the computer software
5. Patient with a neuromuscular or neurosensory deficiency that may affect the ability to evaluate the study endpoints.
6. Patients who are known drug or alcohol abusers or with psychological disorders that could affect follow up care or treatment outcomes.
7. Patients with a history of deep vein thrombosis or other thrombotic disorders.
8. Clinical signs of a coexisting severe acute systemic illness (Pneumonia, sepsis, UTI, other co-morbidities)
9. Diagnosis of immune deficiency (AIDS, other congenital immunodeficiency syndrome, drug therapy with steroids, anticancer drugs etc.)
10. Patient is unlikely to adhere to study procedures, keep appointments, or is planning to relocate during the study.
11. Any other reason that in the opinion of the investigator may interfere with the evaluation required by the study.
|
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
i) To evaluate the accuracy of bone resection by the MAKO software.
ii) To measure the tibial component rotation.
iii) To evaluate the functional outcome at the end of 2 years using patient-reported outcomes and correlate with the accuracy of bone resections and tibial component rotation.
|
Screening. Post-op Day 1, Week 6, Month 3 and year 1 and 2 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| None |
Not Applicable |
|
|
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)
|
15/07/2022 |
| 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
|
Once Study is completed the Investigator and guide shall explore options for publication |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
|
The patients planned for single implant TKA at the
study centre shall be approached for the study. If they agree to participate
and sign the informed consent form, data shall be collected for the study
variables at the following time points, Pre-operative, Post-operative at 6
weeks, 3 months, 1 year and 2 years after surgery.
This shall be a single surgeon series from the study
centre. The surgeon shall record the planned bone resections after initial bone
mapping. A navigated probe shall be used to determine bone resection of the
distal femur, anterior femur, and tibia after bone resection. Computer
measurement of bone resection shall be recorded. Coronal alignment shall be
recorded at trial implantation and definitive implantation. Data shall be
recorded in real-time as screenshots of the MAKO system software and stored
for analysis. Post-op CT shall be done
for all patients.
Data for accuracy of measurements and tibial rotation
shall be collected from pre-op, intra-op and post-op medical records.
WOMAC and KSS shall be administered pre-op and post-op
at 6 weeks, 3 months, 1 year and 2 years.
FJS shall be administered post-op at 6 weeks, 3 months,
1 year and 2 years.
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