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CTRI Number  CTRI/2024/01/061578 [Registered on: 18/01/2024] Trial Registered Prospectively
Last Modified On: 15/01/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Total hip arthroplasty by anterolateral approach. 
Scientific Title of Study   Clinical and radiological outcome of total hip arthroplasty by anterolateral approach: A cross sectional 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  NISHANT KUMAR RUHELA 
Designation  JUNIOR RESIDENT 
Affiliation  ROHILKHAND MEDICAL COLLEGE AND HOSPITAL BAREILLY  
Address  Rohilkhand Medical College and Hospital.Department-Orthopaedics, AC boys hostel Room No 19,Pilibhit Bypas Road, Op. Suresh Sharma Nagar Bareilly, U. P. - 243006, India

Bareilly
UTTAR PRADESH
243006
India 
Phone  9568854478  
Fax    
Email  Nishantbhai0529638@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Lekhraj verma 
Designation  Professor 
Affiliation  ROHILKHAND MEDICAL COLLEGE AND HOSPITAL BAREILLY  
Address  Rohilkhand Medical College and Hospital.Department-Orthopaedics, Faculty hostel ,Pilibhit Bypas Road, Op. Suresh Sharma Nagar Bareilly, U. P. - 243006, India


UTTAR PRADESH
243006
India 
Phone  9568854478  
Fax    
Email  Vermalekhraj@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  NISHANT KUMAR RUHELA 
Designation  JUNIOR RESIDENT 
Affiliation  ROHILKHAND MEDICAL COLLEGE AND HOSPITAL BAREILLY  
Address  Rohilkhand Medical College and Hospital.Department-Orthopaedics, AC boys hostel Room No 19,Pilibhit Bypas Road, Op. Suresh Sharma Nagar Bareilly, U. P. - 243006, India


UTTAR PRADESH
243006
India 
Phone  9568854478  
Fax    
Email  Nishantbhai0529638@gmail.com  
 
Source of Monetary or Material Support  
Rohilkhand medical college and hospital bareilly 
 
Primary Sponsor  
Name  ROHILKHAND MEDICAL COLLEGE AND HOSPITAL BAREILLY  
Address  Rohilkhand Medical College and Hospital.Department-Orthopaedics, AC boys hostel Room No 19,Pilibhit Bypas Road, Op. Suresh Sharma Nagar Bareilly, U. P. - 243006, India 
Type of Sponsor  Private 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 Nishant Kumar Ruhela  ROHILKHAND MEDICAL COLLEGE AND HOSPITAL   Rohilkhand Medical College and Hospital.Department-Orthopaedics, AC boys hostel Room No 19,Pilibhit Bypas Road, Op. Suresh Sharma Nagar Bareilly, U. P. - 243006, India
Bareilly
UTTAR PRADESH 
9568854478

Nishantbhai0529638@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Communication of Decision of the Institutional Ethics Committee (IEC). Rohilkhand Medical College & Hospital, Bareilly, U. P. - 243006  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M169||Osteoarthritis of hip, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Observational study  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1.Age above 18 years old.
2.Any patient requiring total hip replacement would be considered.
3.Participants in the study must have given written, informed consent from their orthopaedic surgeon prior to having a total hip replacement.
4.Femoral neck fractures. (Garden types III and IV and Pauwel’s type III)
5.Femur head avascular necrosis. (Ficat and arlet type III and IV)
6.Hip osteoarthritis (Tonnis grade III)  
 
ExclusionCriteria 
Details  1.Revision Total hip replacement.
2.Medically unfit patient.
3.Active sinus or infection of hip joint.
4.Acetabular Fracture. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To analyse the stages of the Anterolateral Total hip arthroplasty surgical procedure.
To document the advantages and disadvantages of the procedure.
To assess Harris Hip score of patients. 
6 weeks 3 months and 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
To assess clinical parameters like leg length, blood loss, ambulation and gait.
 
6 weeks 3 months and 6 months 
 
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)   25/01/2024 
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="0"
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  

The hip joint normally operates as a "ball-and-socket" joint. The femoral head and acetabulum articulate, allowing smooth range of motion in multiple planes. Any condition that impacts any one of these structures can cause the joint to detoriate. This can result in deformity, discomfort, and functional loss. In primary causes Osteoarthritis is the most typical ailment affecting the hip joint along with idiopathic osteonecrosis alcohol-induced secondary osteonecrosis, Trauma, developmental dysplasia and inflammatory arthritis (including rheumatoid arthritis, psoriatic arthritis, Spondyloarthropathies, etc.) are the other some causes.

Total hip arthroplasty is a procedure that replaces the hip joint to reduce pain and enhance joint function as well prosthetic articular surfaces replaces the damaged ones.A femoral stem is used to replace the resected femoral head during total hip arthroplasty, Which also involves replacing the acetabulum’s articulating surface with an implant Polymethyl methacrylate (PMMA) also referred to as bone cement that can be used to affix the acetabular and femoral component to the bone, as well the Age and sex of the patient should be focused during surgery. 

Uncemented implants work well for younger patients, whereas cemented implants work better for older patients, especially elderly women. 

The total hip replacement procedure was invented by Sir John Charnley. Since then, total hip arthroplasty has shown to be a highly rewarding treatment with positive outcomes throughout the past 40 years. 

Therefore, if the operation is done appropriately, then each patient will observe a better quality of life as well as functional improvement and it is a great way to improve mobility and lessen discomfort. 

In India, 40,000 total hip arthroplasties are being performed each year. The success rate for this surgery has drastically increased with 90-95% of hip replacement surgeries succeed 10 years following surgery, and 80-85% succeed 20 years.

 
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