FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2026/01/100062 [Registered on: 01/01/2026] Trial Registered Prospectively
Last Modified On: 30/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Other 
Public Title of Study   Thirty day post operative complications following primary total knee replacement 
Scientific Title of Study   A prospective observational study on thirty day post operative complications following primary total knee replacement surgery 
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 Sumit Tibrewal  
Designation  Post graduate junior resident orthopaedics  
Affiliation  PGIMS Post Graduate Institute of Medical Sciences Rohtak 
Address  Department of Orthopaedics Post Graduate Institute of Medical Sciences Rohtak PGIMS Rohtak HARYANA 124001 India

Rohtak
HARYANA
124001
India 
Phone  7980377404  
Fax    
Email  stibrewal610@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Pradeep kamboj 
Designation  Senior Professor 
Affiliation  PGIMS Post Graduate Institute of Medical Sciences Rohtak 
Address  Department of Orthopaedics Post Graduate Institute of Medical Sciences PGIMS Rohtak Rohtak HARYANA 124001 India

Rohtak
HARYANA
124001
India 
Phone  9992014147  
Fax    
Email  kambojdr@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Pradeep kamboj 
Designation  Senior Professor 
Affiliation  PGIMS Post Graduate Institute of Medical Sciences Rohtak 
Address  Department of Orthopaedics Post Graduate Institute of Medical Sciences PGIMS Rohtak Rohtak HARYANA 124001 India

Rohtak
HARYANA
124001
India 
Phone  9992014147  
Fax    
Email  kambojdr@gmail.com  
 
Source of Monetary or Material Support  
Department of Orthopaedics PGIMS Rohtak 
 
Primary Sponsor  
Name  Dr. Sumit Tibrewal  
Address  Department of Orthopaedics Post Graduate Institute of Medical Sciences PGIMS Rohtak Pincode 124001 Haryana 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
Department of Orthopaedics PGIMS Rohtak  Department of Orthopaedics PGIMS Rohtak Pincode 124001 Haryana 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Pradeep Kamboj  PGIMS ROHTAK   Department of Orthopaedics PGIMS Rohtak Pincode 124001 Haryana Rohtak HARYANA
Rohtak
HARYANA 
9992014147

kambojdr@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
BIOMEDICAL RESEARCH ETHICS COMMITTEE Pt.B.D.Sharma/UHS, Rohtak  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 
Comparator Agent  Nil  Nil 
Intervention  Total knee arthroplasty   Total knee arthroplasty is a surgical procedure of approximately 90 minutes performed in patients With osteoarthritis of knee joint  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Patients undergoing primay Total knee arthroplasty 
 
ExclusionCriteria 
Details  Patient undergoing total knee arthroplasty for hemophilia arthropathy and malignant disease.
Patient undergoing revision surgery.
Patient undergoing hybrid total knee arthroplasty with all polyethylene tibial components will be excluded from the study 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
2011 Knee Society score, Western Ontario and
McMaster Universities Osteoarthritis Index
WOMAC 
Scores measured pre operative and post operative at first month 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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 3 
Date of First Enrollment (India)   10/01/2026 
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="1"
Months="3"
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   Osteoarthritis is a common disorder of the musculoskeletal system that reduces function and quality
of life and is characterized by joint pain, tenderness, crackling, stiffness, varying degrees of local
inflammation and occasional exudate. Osteoarthritis disease is often activity related. Later, during
the course of illness, constant pain becomes a features. Pain in osteoarthritis is not only due to
structural changes in the affected joint, but is the result of the interaction of structural changes,
peripheral and central pain processing mechanisms. However, pain is not the only result of
osteoarthritis. Pain is related to functions, body movement causes pain, and pain results in limitation
of body functions. Joint stiffness is also common, especially in the morning. Auditory and tactile
"cracking" or "grinding" of the joint, as well as a feeling of instability or bending, are common during
active or passive movements, especially in the later stages. This can result from pain, effusion,
capsular contracture, muscle spasm or weakness, loose body in the joint, mechanical restrictions,
and joint deformity/alignment. Dysfunction is another important factor in osteoarthritis. It is often
associated with joint stiffness. Osteoarthritis causes changes in mobility and function. Patients often
experience physical limitations, personal care issues, work capacity, and even household management issues.
Various treatment modalities for osteoarthritis include exercise, transcutaneous electrical nerve
stimulation (TENS), weight control, chondroitin or glucosamine, acetaminophen duloxetine, oral
non-steroidal anti-inflammatory drugs (NSAIDs), topical NSAIDs, opioids, intra-articular injections
(corticosteroids, platelet rich plasma, hyaluronic acid) and surgeries if no relief from above
mentioned options.
The Kellgren and Lawrence (KL) classification has been commonly used to classify osteoarthritis.
The Kellgren and Lawrence classification also assist healthcare providers with a treatment
algorithm to guide clinical decision-making, specifically defining which patients may benefit most
from surgical management. The KL classification was originally described using AP knee
radiographs. Each radiograph was assigned a grade from 0 to 4, which they correlated to increasing
severity of OA, with Grade 0 signifying no presence of OA and Grade 4 signifying severe OA. Grade
0 is No radiographic features of osteoarthritis. Grade 1 is possible joint space narrowing (normal
joint space is at least 2 mm at the superior acetabulum) and osteophyte formation. Grade 2 is
definite osteophyte formation with possible joint space narrowing. Grade 3 is multiple osteophytes,
definite joint space narrowing, sclerosis and possible bony deformity Grade 4 is large osteophytes,
marked joint space narrowing, severe sclerosis and definite bony deformity.
Total knee arthroplasty (TKA) is an effective surgical treatment for arthritis of knee joint. It is
considered to provide significant pain relief and improves knee function in patients with arthritis with
good long-term results. Total Knee arthroplasty, a surgical procedure to replace weight-bearing
surfaces of knee joint to relieve pain and disability; is an end-of-line treatment for patients with
severe pain and functional limitations.
Total knee arthroplasty (TKA) can be associated with early and late complications. Early complications include wound infection, hematoma, thromboembolic events (DVT, pulmonary embolism), neurovascular injury, and stiffness. Prosthesis-related issues include malalignment, instability, patellar tracking problems, and periprosthetic fractures. Late complications involve aseptic loosening, polyethylene wear, osteolysis, and chronic infection. Persistent pain and limited range of motion may affect outcomes. Rare complications include metal hypersensitivity and extensor mechanism disruption. Careful surgical technique, patient optimization, thromboprophylaxis, and infection prevention strategies are crucial to minimize risks and improve long-term function and implant survival after TKA.
 
Close