| CTRI Number |
CTRI/2020/11/029021 [Registered on: 10/11/2020] Trial Registered Prospectively |
| Last Modified On: |
20/05/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A prospective, observational study to assess the functional recovery, duration of hospital stay, and complications in patients with arthritis undergoing Robotic Total Knee Replacement surgery |
|
Scientific Title of Study
|
A prospective, observational study to assess the functional recovery, duration of hospital stay, and complications of Robot assisted Total Knee Replacement surgery in patients with end stage knee arthritis aged 18-90 years in India – A pilot investigator initiated study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ashish Singh |
| Designation |
Consultant Orthopedic Surgeon and Director |
| Affiliation |
Anup Institute of Orthopedics and Rehabilitation |
| Address |
Ground Floor, OPD Complex, Room No 117, Anup Institute of Orthopedics and Rehabilitation, (AIOR)
G 75, 77, P C Colony Rd, Kankarbagh, Bankman Colony, Patna, India
Patna
BIHAR
800020
India |
| Phone |
8294240349 |
| Fax |
|
| Email |
drashishsingh@hotmail.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 |
Ground Floor, OPD Complex, R No 117,Anup Institute of Orthopedics and Rehabilitation, (AIOR)
G 75, 77, P C Colony Rd, Kankarbagh, Bankman Colony, Patna, India
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 |
Ground Floor, OPD Complex, R No 117,Anup Institute of Orthopedics and Rehabilitation, (AIOR)
G 75, 77, P C Colony Rd, Kankarbagh, Bankman Colony, Patna, India
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 Orthopedics and Rehabilitation, (AIOR)
G 75, 77, P C Colony Rd, Kankarbagh, Bankman Colony, Patna, Bihar 800020, India
|
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Ashish Singh |
Anup Institute of Orthopedics and Rehabilitation |
Ground Floor, OPD Complex, R No 117,Anup Institute of Orthopedics & Rehabilitation, (AIOR)
G 75, 77, P C Colony Rd, Kankarbagh, Bankman Colony, Patna, Bihar 800020, India
Patna
BIHAR |
8294240349
drashishsingh@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC, Anup Institute of Orthopedics and Rehabilitation |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with ends stage knee arthritis eligible for Total knee arthroplasty.
2. Male and female aged 18 years to 90 years
3. Subject is willing to take part in the study by signing Ethics Committee (EC) approved informed consent form (ICF)
4. Subjects agrees to comply with postoperative scheduled clinical and radiographic evaluation
|
|
| ExclusionCriteria |
| Details |
1. Patient with an active infection within the affected knee joint
2. Patient with neuromuscular or neurosensory deficiency that may affect the ability to evaluate the study end points.
3. Patients who are known drug or alcohol abusers or with psychological disorders that could affect follow up care or treatment outcomes.
4. Patients with history of deep vein thrombosis or other thrombotic disorders.
5. Patients for whom the surgical procedure is a revision of a previous TKA or hemi arthoplasty, or who have previously undergone arthrodesis or osteotomy of the knee.
6. Clinical signs of a coexisting severe acute systemic illness (Pneumonia, sepsis, UTI, other co-morbidities)
7. Diagnosis of immune deficiency (AIDS, other congenital
immunodeficiency syndrome, drug therapy with steroids, anticancer drugs etc.)
8. Participation in another clinical study within 30 days before the beginning or anytime during the duration of the current clinical study.
9. Patient is unlikely to adhere to study procedures, keep appointments, or is planning to relocate during the study.
10. Any other reason that in the opinion of the investigator may interfere with the evaluation required by the study.
11. Patient identified as employee of the Investigator or study center as well as family members (i.e. immediate, husband, wife and their children, adopted or natural) of the employees or the Investigator
|
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To observe the functional recovery, duration of hospital stay and complications of Robotic assisted technology in patients undergoing TKA |
Baseline, 5 days post surgery, 6 weeks, 3 month, 6 month, 1 year, 2 year, 3 year and 5 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Changes in pain levels between pre-operation (baseline) and post-operation during the course of the study (before discharge and post-surgery
Total time taken for surgery
Amount of blood loss during surgery
Bone measurements- Anthropometry, Post bone cut extension gap difference in Minimally invasive surgery.
Patients requiring spinal vs general anesthesia
Patients diagnosed with Deep vein thrombosis (DVT)
Patients with infections despite Antibiotic prophylaxis
Implant defects
|
One, two, three and five years |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
16/11/2020 |
| 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="6"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This prospective, observational, Investigator Initiated
study will be conducted at a study sites under the Principal Investigator.
Patients between the ages
of 18 to 90 years, presenting with end stage knee arthritis requiring Total
Knee Arthroplasty (TKA) in the Outpatient Department (OPD) of the investigator
will be considered for the study. |