| CTRI Number |
CTRI/2026/03/105994 [Registered on: 12/03/2026] Trial Registered Prospectively |
| Last Modified On: |
11/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
A CT scan study of how well hip replacements stay in place in patients with sickle cell disease. |
|
Scientific Title of Study
|
Comparison of Acetabular Cup Fixation With and Without Screws in Total Hip Arthroplasty for Sickle Cell Disease: A CT Based Migration Analysis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Darshan Temker Madan |
| Designation |
Senior Resident |
| Affiliation |
AIIMS, Raipur |
| Address |
Department of Orthopaedics, AIIMS Raipur, Great Eastern Road, Tatibandh, Raipur
Raipur CHHATTISGARH 492099 India |
| Phone |
9035838639 |
| Fax |
|
| Email |
temker1997@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Alok C Agrawal |
| Designation |
Professor and Head of Department |
| Affiliation |
AIIMS, Raipur |
| Address |
Department of Orthopaedics, AIIMS Raipur, Great Eastern Road, Tatibandh, Raipur
Raipur CHHATTISGARH 492099 India |
| Phone |
9425151634 |
| Fax |
|
| Email |
dralokcagrawal@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Darshan Temker Madan |
| Designation |
Senior Resident |
| Affiliation |
AIIMS, Raipur |
| Address |
Department of Orthopaedics, AIIMS Raipur, Great Eastern Road, Tatibandh, Raipur
CHHATTISGARH 492099 India |
| Phone |
9035838639 |
| Fax |
|
| Email |
temker1997@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS Raipur Dept of Orthopaedics |
| Address |
AIIMS Raipur, Great Eastern Rd, Tatibandh, Raipur |
| 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 Darshan Temker Madan |
AIIMS Raipur |
Department Office, Department of Orthopaedics, Ground Floor, D - Block, AIIMS Raipur, Great Eastern Rd, Tatibandh, Raipur, Chhattisgarh - 492099 Raipur CHHATTISGARH |
9035838639
temker1997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, AIIMS Raipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M873||Other secondary osteonecrosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Avascular necrosis of hip and known case of sickle cell disease
Willing to undergo CT scan for follow up |
|
| ExclusionCriteria |
| Details |
Those undergoing revision total hip arthroplasty
Osteonecrosis due to other causes like smoking, alcohol and steroid intake
Prior acetabular surgery
Complex deformities requiring use of revision style hip prosthesis |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess implant migration of more than 0.5mm at 1 year follow up using a CT Scan |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess cup stability using Moore’s Radiographic Signs (adapted to CT) in
both groups. |
1 year |
To evaluation changes in cup inclination and version over time in both
groups. |
1 year |
To compare clinical outcomes between the two groups using Modified
Harris Hip Score (mHHS). |
1 year |
|
|
Target Sample Size
|
Total Sample Size="34" Sample Size from India="34"
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)
|
31/03/2026 |
| 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="2" 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report Response - Analytic Code
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [temker1997@gmail.com].
- For how long will this data be available start date provided 10-03-2026 and end date provided 10-03-2028?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Total Hip Arthroplasty (THA) is an effective treatment for end-stage hip disease; however, in patients with Sickle Cell Disease (SCD), altered bone biology poses unique challenges to acetabular component fixation. Poor bone quality, sclerosis, infarcts, and trabecular abnormalities may compromise press-fit stability, leading surgeons to use supplemental acetabular screws based on intraoperative judgment. Despite widespread practice, objective evidence supporting screw fixation in SCD is lacking, and existing studies are largely confined to populations with normal bone biology and rely on low-precision radiographic methods.
This prospective cohort study aims to compare early acetabular cup stability in SCD patients undergoing primary uncemented THA with and without supplemental screw fixation using a CT- based markerless migration analysis. The primary objective is to quantify three-dimensional acetabular cup migration at one year postoperatively. Secondary objectives include evaluation of cup inclination and version changes, assessment of radiological stability using Moore’s signs adapted to CT imaging, and comparison of functional outcomes using the Modified Harris Hip Score (mHHS).
The study will be conducted at the Department of Orthopaedics, AIIMS Raipur, over a two-year period following Institutional Ethics Committee approval. Adult patients (>18 years) with avascular necrosis of the femoral head secondary to SCD undergoing primary unilateral THA will be included. Patients undergoing revision THA, those with AVN due to other etiologies, prior pelvic surgeries, major acetabular defects requiring augments, or inability to comply with follow-up or CT imaging will be excluded. Convenience sampling will be used, with the decision to use screws made intraoperatively based on cup stability.
All patients will undergo standardized preoperative evaluation, surgery, and postoperative rehabilitation. A baseline CT scan of the pelvis and hips will be obtained within one week of surgery, followed by a repeat CT scan at one year. CT-based migration analysis will be performed using 3D Slicer software. The pelvis will serve as the fixed reference body through rigid registration using Iterative Closest Point (ICP) algorithms. Cup migration will be quantified by calculating centroid displacement in superior–inferior, medial–lateral, and anterior–posterior directions, along with rotational changes in inclination and version. Radiological stability will be assessed using Moore’s signs adapted for CT imaging. Functional outcomes will be evaluated using mHHS preoperatively and at 3, 6, and 12 months postoperatively.
Based on prior RSA data, a sample size of 17 patients per group (34 total) has been calculated to detect a clinically meaningful difference in migration.Statistical analysis will compare migration parameters, radiological stability, and functional outcomes between screw and no-screw groups, with correlation analyses to assess relationships between migration and clinical outcomes. This study aims to provide objective, high-precision evidence to guide acetabular fixation strategies in SCD patients undergoing THA |