| CTRI Number |
CTRI/2024/05/066949 [Registered on: 07/05/2024] Trial Registered Prospectively |
| Last Modified On: |
06/05/2024 |
| 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 and virtual reality for patients who have fractures involving their joints. |
|
Scientific Title of Study
|
Can 3-D printing and virtual reality improve outcomes in periarticular fractures - a double blinded randomized controlled trial? |
| Trial Acronym |
PA3DVR |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Siddhartha Sharma |
| Designation |
Additional Professor |
| Affiliation |
Postgraduate Institute of Medical Education and Research, Chandigarh |
| Address |
Department of Orthopedics, Postgraduate Institute of Medical Education and Research, Sector 12, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9988793537 |
| Fax |
|
| Email |
sids82@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Siddhartha Sharma |
| Designation |
Additional Professor |
| Affiliation |
Postgraduate Institute of Medical Education and Research,Chandigarh |
| Address |
Department of Orthopedics, Postgraduate Institute of Medical Education and Research, Sector 12, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9988793537 |
| Fax |
|
| Email |
sids82@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Siddhartha Sharma |
| Designation |
Additional Professor |
| Affiliation |
Postgraduate Institute of Medical Education and Research, Chandigarh |
| Address |
Department of Orthopedics, Postgraduate Institute of Medical Education and Research, Sector 12, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9988793537 |
| Fax |
|
| Email |
sids82@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indian Council for Medical Research, New Delhi |
|
|
Primary Sponsor
|
| Name |
PGIMER, Chandigarh |
| Address |
Department of Orthopedics, PGIMER, CHANDIGARH |
| 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 Siddhartha Sharma |
Advanced Trauma Center, Department of Orthopedics, PGIMER |
PGIMER, Sector 12, Chandigarh, 160012
Chandigarh
CHANDIGARH |
9988793537
sids82@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S40-S49||Injuries to the shoulder and upper arm, (2) ICD-10 Condition: S50-S59||Injuries to the elbow and forearm, (3) ICD-10 Condition: S60-S69||Injuries to the wrist, hand and fingers, (4) ICD-10 Condition: S70-S79||Injuries to the hip and thigh, (5) ICD-10 Condition: S80-S89||Injuries to the knee and lower leg, (6) ICD-10 Condition: S90-S99||Injuries to the ankle and foot, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
3D Printing and virtual reality based pre-operative surgical planning |
The intervention group will consist of surgical planning using 3D printing and virtual reality.3D printed models and virtual reality based visualization and reduction of the fracture will be provided to the surgical team for planning the surgery before the operative procedure is carried out. |
| Comparator Agent |
Standard pre-operative planning |
In this comparator group, the surgical team will plan the case on the basis of conventional surgical planning, which involves X-Rays and CT scans. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients (18 years and above) with an acute (less than 3 weeks from the date of injury) periarticular fracture of the shoulder, elbow, wrist, hip, knee, ankle, or foot, where a CT study has been performed, and operative reduction and internal fixation is indicated, will be included. The following AO OTA 2018 fracture categories will be included: 11, 13, 14, 15.1, 15.3, 2R1, 2U1, 2R3, 2U3, 71, 72, 73, 74, 75, 76, 6, 31, 33, 34, 41, 4F1, 43, 4F3, 44, 8 |
|
| ExclusionCriteria |
| Details |
Pediatric patients, diaphyseal fractures, non-operatively managed patients, patients managed only with external fixation, patients unwilling to participate and those where CT has not been performed will be excluded. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
a) Accuracy of fracture reduction
b) Length of operative time
c) Intraoperative radiation
d) Surgeon satisfaction
e) Perioperative blood loss
Secondary Outcomes
a) Time to union
b) Functional outcomes: EQ5D, SF36, region specific functional outcome scores
c) Cost efficiency analysis |
6 weeks, 3 months, 6 months, 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
a) Time to union
b) Functional outcomes: EQ5D, SF36, region specific functional outcome scores
c) Cost efficiency analysis
d) Types and rates of complications |
6 weeks, 3 months, 6 months, 12 months |
|
|
Target Sample Size
|
Total Sample Size="168"
Sample Size from India="168"
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)
|
30/05/2024 |
| 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="3"
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 - NO
|
|
Brief Summary
|
Objective: The aim of this randomized controlled trial (RCT) is to evaluate the efficacy of 3D printing and virtual reality (VR) for the surgical planning of periarticular fractures in adults. Methods: This is a double-blinded RCT that will include 168 adult patients with periarticular fractures (proximal humerus, elbow, distal radius, carpal, pelvis-acetabular and hip, distal femur, proximal tibia, ankle, and foot fractures), who will be randomized into two groups. Patients and outcome assessors will be blinded. Group A will undergo conventional surgical planning, while Group B will have 3D printing and VR as planning tools. Patients in both groups will be assessed for accuracy of fracture reduction, operative time, blood loss, radiation dose, surgeon satisfaction, functional outcomes, complications, and cost-efficiency. The t-test will be used to compare continuous variables, and the chi-squared test will be used for variables. Expected Outcome: The results of this RCT will provide insight into the effectiveness of using 3D printing and VR in periarticular fracture management. The use of 3D printing and VR in periarticular fracture management has shown promising results in previous studies, but their effectiveness and safety need to be evaluated through a robust RCT. The results of this trial will help determine the benefits and limitations of these new technologies in periarticular fracture management. |