| CTRI Number |
CTRI/2015/04/005704 [Registered on: 20/04/2015] Trial Registered Retrospectively |
| Last Modified On: |
02/01/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to study to compare the outcomes of Calcaneal Fractures operated with Minimally Invasive Surgery(MIS) technique with conventional techniques of ORIF using Extensile lateral approach. |
|
Scientific Title of Study
|
A randomized controlled trial to compare clinic-radiological outcomes of Displaced intra-articular Calcaneal Fractures (DIACFs) fixed with Minimally Invasive Surgery(MIS) technique with conventional techniques of ORIF using Extensile lateral approach. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ankit Khurana |
| Designation |
Orthopedic Resident |
| Affiliation |
PGIMER |
| Address |
H.No 205 2nd floor
Sec 15 A Chandigarh
Chandigarh
CHANDIGARH
160015
India |
| Phone |
8437029392 |
| Fax |
|
| Email |
ankit24388@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr MS Dhillon |
| Designation |
HOD Deptt Of Orthopedics |
| Affiliation |
PGIMER |
| Address |
15, Nehru Hospital
sector 12
PGIMER
Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8437029392 |
| Fax |
|
| Email |
drdhillon@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ankit Khurana |
| Designation |
ORTHOPEDIC RESIDENT |
| Affiliation |
PGIMER |
| Address |
Department of orthopedics
15, Nehru Hospital
Sector 12, PGIMER
Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8437029392 |
| Fax |
|
| Email |
ankit24388@gmail.com |
|
|
Source of Monetary or Material Support
|
| PGIMER(Post Graduate Institute of Medical Education & Research) |
|
|
Primary Sponsor
|
| Name |
PGIMER |
| Address |
SECTOR 12
CHANDIGARH 160012 |
| Type of Sponsor |
Research institution |
|
|
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 Ankit Khurana |
Advanced Trauma Centre |
Sector 12
PGIMER
Chandigarh
CHANDIGARH |
8437029392
ankit24388@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| InstituteEthicscommittee(intramural) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
calcaneal fracture, (1) ICD-10 Condition: S920||Fracture of calcaneus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intervention Minimally Invasive Surgery(MIS)
|
Minimally Invasive Surgery(MIS)
versus ORIF by Extensile lateral approach
|
| Comparator Agent |
ORIF by Extensile lateral approach
|
Minimally Invasive Surgery(MIS) versusd ORIF by Extensile lateral approach |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Any closed intra-articular calcaneal fracture in patients between 18 years of age and 70 years of age. |
|
| ExclusionCriteria |
| Details |
1. Patient outside the age range specified above
2. Undisplaced fractures (Sanders type 1) and Extra articular fractures
3. Cases in which there is sensory/motor loss in bilateral lower limbs due to assosciated head injury or paraplegia
4. Patients presenting with fracture of calcaneus associated with severe crushing and near total amputation.
5. Pathological fractures
6. Compromising comorbid conditions like skin infections, ulcers etc. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Bohlers and Gissane’s Angle |
preop and postop |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| AOFAS score |
3 weeks 6 weeks 3 months 6 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="21" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/01/2014 |
| Date of Study Completion (India) |
31/12/2015 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Published
Foot (Edinb). 2017 Jun;31:23-30. doi: 10.1016/j.foot.2017.01.008. Epub 2017 Feb 20.
Outcome evaluation of minimally invasive surgery versus extensile lateral approach in management of displaced intra-articular calcaneal fractures: A randomised control trial |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This study is a randomized, parallel group, trail comparing the outcomes of Displaced intra-articular Calcaneal Fractures (DIACFs) fixed with Minimally Invasive Surgery(MIS) technique with conventional techniques of ORIF using Extensile lateral approach. that will be conducted in PGIMER, Chandigarh, India. The primary outcome measures will be post op Bohlers and gissanes angle. The secondary outcome measure will be AOFAS score at 3 weeks 6 weeks 3 months and 6 months. We found comparable radiological outcomes however functional outcomes were better with extensile lateral approach |