| 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
|
|
|
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. |