| 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
|
|
|
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
|
|
|
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. |