| CTRI Number |
CTRI/2025/10/095920 [Registered on: 13/10/2025] Trial Registered Prospectively |
| Last Modified On: |
09/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Use of 3D printing to help treat heel bone fractures |
|
Scientific Title of Study
|
3D printing assisted reduction and internal fixation for calcaneal fractures |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Asjad Mahmood |
| Designation |
Assistant Professor |
| Affiliation |
Jai Prakash Narayan Apex Trauma Centre, AIIMS, New Delhi |
| Address |
Room 410, Faculty cabin, 4th floor, Jai Prakash Narayan Apex Trauma Centre, AIIMS, New Delhi
New Delhi
DELHI
110049
India |
| Phone |
9968856990 |
| Fax |
|
| Email |
mahmoodasjad@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Asjad Mahmood |
| Designation |
Assistant Professor |
| Affiliation |
Jai Prakash Narayan Apex Trauma Centre, AIIMS, New Delhi |
| Address |
Room 410, Faculty cabin, 4th floor, Jai Prakash Narayan Apex Trauma Centre, AIIMS, New Delhi,
New Delhi
DELHI
110049
India |
| Phone |
9968856990 |
| Fax |
|
| Email |
mahmoodasjad@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Asjad Mahmood |
| Designation |
Assistant Professor |
| Affiliation |
Jai Prakash Narayan Apex Trauma Centre, AIIMS, New Delhi |
| Address |
Room 410, Faculty cabin, 4th floor,Jai Prakash Narayan Apex Trauma Centre, AIIMS, New Delhi
New Delhi
DELHI
110049
India |
| Phone |
9968856990 |
| Fax |
|
| Email |
mahmoodasjad@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Ansari Nagar, New Delhi, India - 110029 |
|
|
Primary Sponsor
|
| Name |
AIIMS Intramural grant |
| Address |
Research section, JLN Auditorium, First Floor, AIIMS, Ansari Nagar, New Delhi -110024 |
| 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 Asjad Mahmood |
AIIMS, New Delhi |
Room no 410, Faculty cabin, Department of Orthopaedics, Jai Prakash Narayan Apex Trauma Centre, Ring Rd, Raj Nagar, Safdarjung Enclave, New Delhi, Delhi 110029
New Delhi
DELHI |
9968856990
mahmoodasjad@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC,AIIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S920||Fracture of calcaneus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
3D printing–assisted reduction and fixation of fractured calcaneum bone |
Patients with intra-articular displaced calcaneal fractures planned for operative management will be randomized to undergo surgery assisted by 3D printing technology.
For patients in this group, a 3D-printed model of the fractured calcaneus will be created based on CT data. The printed model will be used to simulate the surgical procedure preoperatively, allowing better understanding of fracture geometry and planning of reduction and fixation. The intraoperative steps will follow the preoperative simulation to achieve anatomical reduction and fixation |
| Comparator Agent |
Conventional reduction and fixation of fractured calcaneum bone |
Patients in the control group will undergo conventional surgical reduction and internal fixation of intra-articular displaced calcaneal fractures, planned based on standard radiological imaging (CT and X-ray) without the use of 3D printing or preoperative modeling |
|
|
Inclusion Criteria
|
| Age From |
18.00 Day(s) |
| Age To |
65.00 Day(s) |
| Gender |
Both |
| Details |
Patients with acute, closed, displaced, Sanders type II, III or IV unilateral or bilateral calcaneal fracture without associated ipsilateral lower limb injury. |
|
| ExclusionCriteria |
| Details |
1.Patients with previous history of ankle or foot surgery.
2.Pathological fractures, open fractures, severe soft tissue injuries (Tscherne and Oestern closed grade II and grade III).
3.Patients with existing ipsilateral ankle or foot deformity.
4.Patients not giving consent for the study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Operative time (in minutes) for surgical fixation of intra-articular calcaneal fractures |
Measured intraoperatively at the time of surgery for each patient (single time point) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Number of intraoperative fluoroscopy exposures (C-arm shots) used during fixation of calcaneal fractures |
Measured intraoperatively during the surgery for each patient (single time point) |
| Radiographic parameters – Böhler’s angle, Gissane’s angle, calcaneal height, & calcaneal width |
Immediately postoperative (within 1 week after surgery) & at final follow-up (6 months postoperatively) |
| Functional outcome evaluated by the American Orthopaedic Foot & Ankle Society (AOFAS) Ankle–Hindfoot Score & Visual Analogue Scale (VAS) for pain |
At 6 weeks, 3 months, & 6 months postoperatively |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
20/10/2025 |
| 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="1"
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
|
Traditionally surgery for calcaneal fracture is usually
performed after preoperative planning based on X-ray and CT, which give only a
limited understanding of the fracture patterns. With the 3D printing technology
becoming more accessible technically and financially, it has been widely used
in the field of orthopedics, allowing preoperative planning of the surgical
approach on the 3D model including the reproduction of the design and size of
the hardware that would be used for osteosynthesis during surgery. |