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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  
NIL 
 
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  
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 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  
Status 
Not Applicable 
 
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
  1. 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).

  2. 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

  3. 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.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [temker1997@gmail.com].

  6. 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.

  7. 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

 
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