| CTRI Number |
CTRI/2024/01/062034 [Registered on: 30/01/2024] Trial Registered Prospectively |
| Last Modified On: |
03/09/2024 |
| 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
|
THE COMPARISON OF POST OPERATIVE RECOVERY AND OUTCOME OF TOTAL HIP REPLACEMENT SURGERY, WHEN PERFORMED BY DIRECT ANTERIOR APPROACH IN COMPARISON WITH POSTERIOR APPROACH |
|
Scientific Title of Study
|
THE COMPARISON OF CLINICAL AND RADIOLOGICAL
OUTCOMES OF TOTAL HIP ARTHROPLASTY WITH DIRECT
ANTERIOR APPROACH VERSUS POSTERIOR APPROACH –
A RANDOMISED CONTROL TRIAL |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Arjun C |
| Designation |
Junior Resident |
| Affiliation |
AIIMS New Delhi |
| Address |
Room 205 Doctors Hostel AIIMS JPNATC Trauma Center AIIMS New Delhi
Room 205 Doctors Hostel AIIMS JPNATC Trauma Center AIIMS New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9986771186 |
| Fax |
|
| Email |
mailtoarjun.c@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajesh Malhotra |
| Designation |
Professor |
| Affiliation |
AIIMS New Delhi |
| Address |
Room 5019, 5th Floor, Teaching Block, AIIMS, New Delhi
East
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
rmalhotra62ortho@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Arjun C |
| Designation |
Junior Resident |
| Affiliation |
AIIMS, New Delhi |
| Address |
Department of Orthopaedics
AIIMS, New Delhi
Ansari Nagar, Ansari Nagar East, New Delhi, Delhi 110029
New Delhi
DELHI
110029
India |
| Phone |
9986771186 |
| Fax |
|
| Email |
mailtoarjun.c@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS NEW DELHI |
| Address |
Department of Orthopaedics
AIIMS New Delhi |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Arjun C |
AIIMS, New Delhi |
DEPARTMENT OF ORTHOPAEDICS, Room no- 5019/5036 (A),5th Floor, Teaching Block, AIIMS New Delhi
New Delhi
DELHI |
9986771186
mailtoarjun.c@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, AIIMS New Delhi |
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 |
Total Hip Arthroplasty using Direct Anterior Approach |
Direct Anterior Approach to the hip joint will be used to perform total hip arthroplasty
with an approximate duration of 2 hours. |
| Comparator Agent |
Total Hip Arthroplasty using Posterior Approach |
Posterior Approach to hip joint will be used to perform total hip arthroplasty, also with an approximate duration of 2 hours |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients aged between 18-70 years with unilateral symptomatic hip arthritis undergoing unilateral cementless THA. |
|
| ExclusionCriteria |
| Details |
1. Patients with previous prosthetic hip replacement devices/ revision surgeries.
2. Patients aged less than 18 years or more than 70 years.
3. Patients with the presence of infections- highly communicable diseases like AIDS, venereal diseases, hepatitis, pulmonary tuberculosis.
4. Patients undergoing simultaneous hip and knee arthroplasty.
5. Patients not giving consent.
6. Patient having contralateral symptomatic hip arthritis.
7. Patients with Crowe 3 and 4 hip dysplasias.
8. Patients with neuromuscular disorders or musculoskeletal disorders or diseases that may adversely affect normal weight bearing or gait
9. Patients with active major psychiatric illness or active metastatic disease.
10. Patients with spinopelvic involvement and difference in sacral slope in standing and sitting lateral spine x ray less than 10º. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the clinical and radiological outcomes of THA with direct anterior approach
(DAA) versus posterior approach. |
Preoperative period upto 1 year of Postoperative follow up, including regular follow ups at 2 weeks, 6 weeks, 3 months and 1 year. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• To compare tissue damage between Direct Anterior Approach (DAA) versus Posterior Approach THA by blood tests and MRI.
• To compare functional outcomes between DAA vs Posterior approach THA using patient reported outcome scores and Gait analysis.
• To compare rate of return to activities of daily living using a milestone diary.
• To compare the radiological outcomes between the two groups for optimal implant positioning and leg length using standard radiographs and EOSTM scan. |
Preoperative period upto 1 year of Postoperative follow up, including regular follow ups at 2 weeks, 6 weeks, 3 months and 1 year. |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
05/02/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study aims to compare the clinical and radiological outcomes in patients undergoing Total Hip Arthroplasty (THA) with direct anterior approach (DAA) versus posterior approach. Blood tests, MRI, EOS scan, Gait analysis, Radiological and clinical evaluation shall be done at preoperative period, immediate postop period, and at 2 weeks, 6 weeks, 3 months and 1 year postoperatively. Primary objectives being: • To compare tissue damage between Direct Anterior Approach (DAA) versus Posterior Approach THA by blood tests and MRI. • To compare functional outcomes between DAA vs Posterior approach THA using patient reported outcome scores and Gait analysis. • To compare rate of return to activities of daily living using a milestone diary. • To compare the radiological outcomes between the two groups for optimal implant positioning and leg length using standard radiographs and EOSTM scan.
|