| CTRI Number |
CTRI/2026/03/106446 [Registered on: 18/03/2026] Trial Registered Prospectively |
| Last Modified On: |
02/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
DOES THE TIMING OF THE SECOND SURGERY IN STAGGERED BILATERAL TOTAL KNEE REPLACEMENT INFLUENCE THE PERIOPERATIVE OUTCOMES - A PROSPECTIVE COHORT STUDY |
|
Scientific Title of Study
|
DOES THE TIMING OF THE SECOND SURGERY IN STAGGERED BILATERAL TOTAL KNEE REPLACEMENT INFLUENCE THE PERIOPERATIVE OUTCOMES - A PROSPECTIVE COHORT STUDY |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Tandlam Manish Reddy |
| Designation |
MS (Orthopedics) |
| Affiliation |
Ganga Medical Center and Pvt Hospitals Ltd |
| Address |
OPD 5,
B - BLOCK, Department of Arthroplasty,
Ganga Medical Center and Pvt Hospital Ltd.
313, Mettupalayam Road, Sai baba colony, Coimbatore
Coimbatore
TAMIL NADU
641043
India |
| Phone |
7013239898 |
| Fax |
|
| Email |
manish126reddy@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Tandlam Manish Reddy |
| Designation |
MS (Orthopedics) |
| Affiliation |
Ganga Medical Center and Pvt Hospitals Ltd |
| Address |
Ganga Medical Center and Pvt Hospital Ltd.
313, Mettupalayam Road, Sai baba colony, Coimbatore
TAMIL NADU
641043
India |
| Phone |
7013239898 |
| Fax |
|
| Email |
manish126reddy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Tandlam Manish Reddy |
| Designation |
MS (Orthopedics) |
| Affiliation |
Ganga Medical Center and Pvt Hospitals Ltd |
| Address |
Ganga Medical Center and Pvt Hospital Ltd.
313, Mettupalayam Road, Sai baba colony, Coimbatore
TAMIL NADU
641043
India |
| Phone |
7013239898 |
| Fax |
|
| Email |
manish126reddy@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ganga Medical Center and Pvt hospital Ltd |
|
|
Primary Sponsor
|
| Name |
Ganga Medical Center and Pvt hospitals Ltd |
| Address |
Ganga Medical Center and Pvt Hospital Ltd.
313, Mettupalayam Road, Sai baba colony, Coimbatore |
| 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 |
| Tandlam Manish Reddy |
Ganga Medical Center and Pvt hospitals |
OPD - 5, B-Block, Department of Arthropalsty, Ganga Medical Center and Pvt Hospital Ltd.
313, Mettupalayam Road, Sai baba colony, Coimbatore
Coimbatore
TAMIL NADU |
7013239898
manish126reddy@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M170||Bilateral primary osteoarthritis of knee, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Radiology KL 3 or 4
ASA - I or II or III
HBA1C - 8 or Lower
Routine Cardiology Clearance |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Evaluate Clinical outcomes among patient groups who underwent Bilateral Staggered TKA
Variables to be considered
Lab Parameters - CRP, IL-6.
PROM’s – New Oxford Knee Score
Clinical Picture
Timed Up and Go Test (TUG)
Knee ROM and SLR
Pain - VAS |
All the parameters will be assessed at baseline, POD 1, 3 and Followup at 1st month and 3rd month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To catergorize Complications & Interventions if any
Minor complications
Urinary Retention, UTI
DVT (Includes Desaturation, Tachypnoea & Tachycardia)
SSI
Major complications
PTE
CVA
Infection
Return to OR
MI/Death
Interventions
Blood/ Blood Products or Colloid Tranfusions
Intubation, Ventilation & Resucitation
|
All the parameters will be assessed at baseline, POD 1, 3 & Followup at 1st month & 3rd month |
|
|
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)
|
27/03/2026 |
| 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="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
•Total knee arthroplasty (TKA) remains the surgical intervention of choice for patients who have debilitating bilateral knee osteoarthritis (OA). •Can be performed
•Simultaneously (one procedure under the same anesthesia),
•Staggered (two separate procedures during a single hospitalization with a specified gap between procedures),
•Staged (two surgeries in two hospital admissions separated by several months). •Simultaneous bilateral TKA
•Single period of hospitalization and anesthesia exposure
•Lower medical costs and better overall recovery time.
•Primary concern with simultaneous bilateral TKA includes a higher risk of major complications, such as increased cardiovascular stress and thromboembolic events.
•Staged TKA - Cons – Longer gap between procedures • Staggered TKA - might reduce the incidence of postoperative complications.
•The physiological stress induced by staggered TKA was a concern, as the procedure involves two separate surgical events, which could amplify the systemic inflammatory response. • There have been several studies done aimed at optimizing the surgical protocol for bilateral TKA patients • |