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CTRI Number  CTRI/2026/03/105736 [Registered on: 09/03/2026] Trial Registered Prospectively
Last Modified On: 22/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Study to evaluate the effect of negative suction drain after Total Knee Replacement 
Scientific Title of Study   Prospective cohort study to analyse the effect of negative suction drain in Total Knee Arthroplasty 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Pradeep Kamboj 
Designation  Senior Professor and Unit Head, Department of Orthopaedics, PGIMS Rohtak 
Affiliation  Department of Orthopaedics, PGIMS Rohtak 
Address  Department of Orthopaedics, Pt B D Sharma PGIMS, Rohtak, Haryana
Department of Orthopaedics, Pt B D Sharma PGIMS, Rohtak, Haryana
Rohtak
HARYANA
124001
India 
Phone  9992014147  
Fax    
Email  kambojdr@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sanchit Bansal 
Designation  MS Post Graduate Student  
Affiliation  Department of Orthopaedics, Pt B D Sharma PGIMS Rohtak 
Address  Department of Orthopaedics, PGIMS Rohtak
Department of Orthopaedics, PGIMS, Rohtak, Haryana
Rohtak
HARYANA
124001
India 
Phone  9466017151  
Fax    
Email  sanchitbansal199@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sanchit Bansal 
Designation  MS Post Graduate Student  
Affiliation  Department of Orthopaedics, Pt B D Sharma PGIMS Rohtak 
Address  Department of Orthopaedics, Pt B D Sharma PGIMS, Rohtak, Haryana
Department of Orthopaedics, PGIMS Rohtak, Haryana
Rohtak
HARYANA
124001
India 
Phone  9466017151  
Fax    
Email  sanchitbansal199@gmail.com  
 
Source of Monetary or Material Support  
Pt B D Sharma PGIMS, Rohtak, Haryana, Pin Code 124001 
 
Primary Sponsor  
Name  Pt B D Sharma PGIMS Rohtak 
Address  Pt B D Sharma PGIMS, Rohtak, Haryana, Pin Code 124001 
Type of Sponsor  Government medical college 
 
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 Sanchit Bansal  Pt B D SHARMA PGIMS  Department of Orthopaedics , Pt B D Sharma PGIMS, Rohtak, Haryana, Pin Code - 124001
Rohtak
HARYANA 		 9466017151

sanchitbansal199@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Biomedical Research Ethics Committee, PGIMS, Rohtak  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M171||Unilateral primary osteoarthritisof knee,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  TKA with drain  This group include patients in which drain was fixed intraoperatively and removed later 
Comparator Agent  TKA without drain  This group includes patients in whom drain was not inserted intraoperatively 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Patients undergoing primary tka with posterior stablised or cruciate sacrificing prosthesis 
 
ExclusionCriteria 
Details  Patients with coagulopathy, inflammatory arthritis, simulataneous bilateral tkr, malignancy, revision tkr and patients on long term anticoagulant therapy 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To assess the effects of surgical drains on postoperative wound complications such as hematoma, infection, and delayed wound healing.  immediate and 1 month 
 
Secondary Outcome  
Outcome  TimePoints 
1. To evaluate the effect of drain usage on postoperative pain and knee swelling.
2. To compare the total blood loss and need for blood transfusions between patients
with and without drains.
3. To determine differences in functional outcomes and recovery times (range of motion, hospital stay duration, time to mobilization) between the two groups.
4. To determine the difference in incidence of 1 month postoperative complications in patients with and without drains 		 immediate and one month 
 
Target Sample Size   Total Sample Size="24"
Sample Size from India="24" 
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   Phase 4 
Date of First Enrollment (India)   09/03/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  09/03/2026 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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) is a commonly performed procedure for advanced knee osteoarthritis. Postoperative closed suction drains are traditionally used to reduce hematoma formation, swelling, and wound complications. However, recent evidence suggests that drain usage may increase blood loss, transfusion requirements, and delay functional recovery without providing significant clinical benefit.

This prospective randomized controlled trial aims to compare the clinical and functional outcomes of patients undergoing primary total knee arthroplasty with and without postoperative closed suction drainage. A total of 24 patients will be randomly allocated into two groups: Group A (drain group) and Group B (no-drain group). Primary outcomes include postoperative hemoglobin drop and total blood loss. Secondary outcomes include wound complications, postoperative pain, functional outcome assessed using WOMAC score at 1 month, transfusion requirement, and duration of hospital stay.

The findings of this study will help determine whether routine use of postoperative suction drains provides any clinical or functional advantage in patients undergoing primary total knee arthroplasty.

 
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