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CTRI Number  CTRI/2025/09/095196 [Registered on: 22/09/2025] Trial Registered Prospectively
Last Modified On: 17/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A randomised control trial to determine whether considering spine and pelvic relationship improves outcomes after hip replacement in patients with low back pain. 
Scientific Title of Study   Impact of consideration of Spinopelvic Mobility on Functional outcomes in total hip Arthroplasty for patients with Low Back Ache: A Randomized Control Trial. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Trish Chetan Shetty 
Designation  Resident, Department of Orthopaedics 
Affiliation  Datta Meghe Institute of Higher Education and Research 
Address  A-2501/2, Cosmic Heights, Bhakti Park, Wadala East, Mumbai

Mumbai
MAHARASHTRA
400037
India 
Phone  9773096403  
Fax    
Email  trish.shetty@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sandeep Shrivastava 
Designation  Professor, Department of Orthopaedics 
Affiliation  Datta Meghe Institute of Higher Education and Research 
Address  3rd Floor, Faculty Residence, DMIHER Campus, Sawangi (Meghe), Wardha

Wardha
MAHARASHTRA
442001
India 
Phone  9765404068  
Fax    
Email  dmiherglobal@dmiher.edu.in  
 
Details of Contact Person
Public Query
 
Name  Dr Trish Chetan Shetty 
Designation  Resident, Department of Orthopaedics 
Affiliation  Datta Meghe Institute of Higher Education and Research 
Address  A-2501/2, Cosmic Heights, Bhakti Park, Wadala East, Mumbai

Mumbai
MAHARASHTRA
400037
India 
Phone  9773096403  
Fax    
Email  trish.shetty@yahoo.com  
 
Source of Monetary or Material Support  
ICMR MDMS Thesis Support- Applied, decision pending. 
Jawaharlal Nehru Medical College, Wardha 
 
Primary Sponsor  
Name  Jawaharlal Nehru Medical College, Wardha 
Address  Sawangi (Meghe), Wardha- 442107, Maharashtra, India 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
MDMSDMMChDNBDrNBMDS Thesis Support Applied decision pending  Department of Health Research 2nd Floor, IRCS Building, 1, Red Cross Road, New Delhi - 110001. 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Trish Shetty  Acharya Vinoba Bhave Rural Hospital  Department of Orthopaedics, DMIHER Campus, Sawangi (Meghe), Wardha- 442107
Wardha
MAHARASHTRA 
07152287701

trish.shetty@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, DMIHER (DU)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M549||Dorsalgia, unspecified, (2) ICD-10 Condition: M169||Osteoarthritis of hip, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional placement of THA implant  Total Hip Arthroplasty (THA) performed with conventional positioning and alignment of components, without specific consideration of spinopelvic mobility.  
Intervention  Customised placement of THA implant  Total Hip Arthroplasty (THA) with preoperative and intraoperative planning based on patient’s spinopelvic mobility. Acetabular cup orientation and component positioning will be adjusted according to spinopelvic parameters assessed through standing and sitting radiographs. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  -Adults with hip osteoarthritis and chronic low back ache undergoing primary Total Hip Replacement
-Able to undergo sitting and standing radiographs of lumbosacral spine 
 
ExclusionCriteria 
Details  -Revision Hip Arthroplasty
-Neurological disorders
-Any other condition affecting True Outcome Analysis based on criteria included Randomization and Groups
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Functional outcome after THA, measured by Harris Hip Score (HHS) at 12 months post-surgery.  Baseline (pre-operative), 3 months, 6 months, and 12 months post-surgery. 
 
Secondary Outcome  
Outcome  TimePoints 
Gait analysis of randomly selected patients on Xsens Analyse system  Baseline (pre-operative), 3 months, 6 months, & 12 months post-surgery. 
 
Target Sample Size   Total Sample Size="26"
Sample Size from India="26" 
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)   07/10/2025 
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="6"
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  
This study is a randomized controlled trial designed to evaluate the impact of considering spinopelvic mobility during preoperative planning on functional outcomes in patients with chronic low back pain who undergo total hip arthroplasty. Adult patients (aged 18 and above) with hip osteoarthritis and chronic low back ache will be recruited, subject to inclusion and exclusion criteria. After randomization, the intervention group will undergo a detailed spinopelvic assessment—both clinical and radiological—including standing and sitting spine-pelvis radiographs to measure pelvic incidence, pelvic tilt, sacral slope, and lumbar flexibility. Conventional preoperative assessment without targeted spinopelvic evaluation will be done in the control group. Surgery will follow standardized protocols, with implant positioning based on spinopelvic parameters in the intervention group and conventional alignment in controls. Outcomes including the Harris Hip Score, SF-36 for back pain, radiological cup placement parameters, and gait analysis will be assessed at baseline, 6 weeks, 3 months, and 6 months postoperatively. The study will be conducted at the Department of Orthopaedics, Jawaharlal Nehru Medical College & Acharya Vinoba Bhave Rural Hospital, Wardha, from October 2025 onwards, enrolling a minimum of 26 patients. Ethical approval has been obtained from the Institutional Ethics Committee, and informed consent will be secured from all participants.
 
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