| CTRI Number |
CTRI/2020/02/023560 [Registered on: 25/02/2020] Trial Registered Prospectively |
| Last Modified On: |
20/02/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparative study to evaluate the effectiveness of treatment options for single sided cheek bone fracture by using one plate fixation and two plates fixation |
|
Scientific Title of Study
|
Comparison of One Point Fixation And
Two Point Fixation For Treatment Of
Unilateral Zygomaticomaxillary complex fracture -A Randomized
Controlled Trial
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vasvani Dimple Maheshbhai |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences, Rishikesh |
| Address |
1st floor, C1 block,Department of craniomaxillofacial Surgery/ Dentistry,
Aiims Rishikesh,
Veerbhadra marg, Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
8445763840 |
| Fax |
|
| Email |
Dvasvani95@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashi Chug |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences, Rishikesh |
| Address |
1st floor, C1 block,Department of craniomaxillofacila surgery / Dentistry, AIIMS Rishikesh,
Rishikesh
249203
Dehradun
UTTARANCHAL
249203
India |
| Phone |
8475000290 |
| Fax |
|
| Email |
ashichug@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vasvani Dimple Maheshbhai |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences, Rishikesh |
| Address |
1st floor, C1 block,Department of craniomaxillofacial Surgery/ Dentistry,
Aiims Rishikesh,
Veerbhadra marg, Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
8445763840 |
| Fax |
|
| Email |
Dvasvani95@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute Of Medical Science, Rishikesh 249203 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences Rishikesh |
| Address |
Veerbhadhra Road, Shivaji nagar, Rishikesh, Uttarakhand 249203 |
| 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 Vasvani Dimple |
All India Institute of Medical sciences Rishikesh |
1st floor, C1 block, Department of Craniomaxillofacial surgery/ dentistry
Dehradun
UTTARANCHAL |
8445763840
Dvasvani95@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee, AIIMS, Rishikesh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S024||Fracture of malar, maxillary and zygoma bones, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
no comparator |
no comparator
as comparison will be done between the two groups and intervention will be done in both.
no other comparator or control group taken.
|
| Intervention |
One point fixation
Group I |
Fixation of zygomaticomaxillary complex fracture will be done at zygomaticomaxillary buttress. |
| Intervention |
Two point fixation
Group II |
Fixation of zygomaticomaxillary complex fracture will be done at zygomaticomaxillary buttress and frontozygomatic region |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients having Unilateral ZMC fracture.
Patient Aged more than 18 years and all genders
Patients ready to give written informed consent
|
|
| ExclusionCriteria |
| Details |
Patients with Severely comminuted ZMC fracture
Patients having Orbital floor fracture associated with ZMC fracture
Pregnant patients
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Surgical outcomes (Operating time, Postoperative pain using visual analog scale (1-10) and swelling measured using measuring tape-Schultze Mosgau et al-
s1: from tragus of ear to corner of mouth
s2: from tragus of ear to soft tissue pogonion.
s3: from lateral canthus of eye to angle of mandible) after
one-point and two-point fixation of unilateral zygomaticomaxillary complex
fracture.
|
First postoperative day, seventh postopeartive day.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Radiographic changes and Post-operative sequalae (Wound dehiscence,
Infection, Plate palpability, Paresthesia, Scar) after one-point and two-point
fixation of unilateral zygomaticomaxillary complex fracture.
|
seventh postoperative day, 1 month postoperatively,3 months postoperatively |
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
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)
|
01/03/2020 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Kim ST1, Go DH, Jung JH, Cha HE, Woo JH, Kang IG. Comparison of 1-
point fixation with 2-point fixation in treating tripod fractures of the zygoma.
J Oral Maxillofac Surg. 2011 Nov;69(11):2848-52
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is randomized controlled trial of unilateral zygomaticomaxillary complex fracture which compares one point fixation with two point fixation in terms of surgical and radiographic outcomes. |