| CTRI Number |
CTRI/2022/04/041826 [Registered on: 12/04/2022] Trial Registered Prospectively |
| Last Modified On: |
04/02/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To evaluate the result of using precontoured plates to fix clavicle fractures |
|
Scientific Title of Study
|
To evaluate the outcome of management of displaced clavicular fractures using
precontoured clavicular plates
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rakesh Kumar Gupta |
| Designation |
Senior Professor |
| Affiliation |
PGIMS Rohtak |
| Address |
Department of Orthopaedics
Pt BD Sharma PGIMS Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9896297534 |
| Fax |
|
| Email |
drrk60@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shagnik Paul |
| Designation |
Junior Resident |
| Affiliation |
PGIMS Rohtak |
| Address |
Department of Orthopaedics
Pt BD Sharma PGIMS Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9749234316 |
| Fax |
|
| Email |
shagnikpaul16@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shagnik Paul |
| Designation |
Junior Resident |
| Affiliation |
PGIMS Rohtak |
| Address |
Department of Orthopaedics
Pt BD Sharma PGIMS Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9749234316 |
| Fax |
|
| Email |
shagnikpaul16@gmail.com |
|
|
Source of Monetary or Material Support
|
| GOVERNMENT MEDICAL COLLEGE |
|
|
Primary Sponsor
|
| Name |
Pt BD Sharma PGIMS Rohtak |
| Address |
Dept of Orthopaedics, Pt BD Sharma PGIMS Rohtak |
| Type of Sponsor |
Government medical college |
|
|
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 Shagnik Paul |
Pt BD Sharma PGIMS Rohtak |
Research Lab,Department of Orthopaedics, Pt BD Sharma PGIMS Rohtak
Rohtak
HARYANA |
9749234316
shagnikpaul16@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical research ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: V80-V89||Other land transport accidents, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Precontoured clavicular plates |
Precontoured clavicular plates (LCP Superior Anterior Clavicular plates, Clavicular plate with lateral extension, VALCP Anterior clavicle plate, LCP Clavicle hook plate) shall be used to fix displaced clavicular fractures in a time period of 1 year |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
All clavicular fractures with the following features:
Displacement > 2 cm
Shortening > 2 cm
Comminution (> 3 fragments)
Segmental fractures
Obvious clinical deformity
Floating shoulder
Fractures with skin tethering or soft tissue interposition
Fractures involving neurovascular compromise
Old fractures with nonunion |
|
| ExclusionCriteria |
| Details |
All clavicle fractures which are:
Pathological fractures
Undisplaced fractures
Age < 18 years |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Radiological
features of union shall be looked for, such as, gradual disappearance of fracture line and
cortical continuity.
Functional outcome as assessed by Constant Score |
Radiological
features of union shall be looked for, such as, gradual disappearance of fracture line and
cortical continuity in 1 year.
Functional outcome as assessed by Constant Score, for a time of 1year. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Complications such as non-union, malunion, hardware prominence, soft tissue irritation,
superficial skin infection, etc. shall be assessed along with the incidence of implant removal shall be assessed along with its cause. |
Complications such as non-union, malunion, hardware prominence, soft tissue irritation,
superficial skin infection, etc. shall be assessed along with the incidence of implant removal shall be assessed along with its cause in a span of 1year |
|
|
Target Sample Size
|
Total Sample Size="25"
Sample Size from India="25"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="27" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/05/2022 |
| Date of Study Completion (India) |
03/11/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Informed Consent Form
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [shagnikpaul16@gmail.com].
- For how long will this data be available start date provided 01-03-2022 and end date provided 01-08-2023?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
Brief Summary
Modification(s)
|
1. In the present study, a majority of the patients were in the younger age group with an overall range of 18-62 years and a mean of 36 years. This pattern was found to be statistically significant (p < 0.01). 2. Road traffic accidents were observed to be the most common mode of injury. 3. There were 20 cases of Robinson type 2B1, 3 cases of type 2B2 and 4 cases of type 3B1. All the cases were managed using 3.5 mm precontoured clavicular LCPs. Lateral extension plates were used in three cases where ligamentous instability was suspected in the lateral third of the clavicle. 4. In the present study, 25 cases achieved radiological union with a mean healing time of 13.8 weeks. Around 58% of the subjects were smokers. It was observed that smoking led to a significantly longer mean healing time (110 days) than that of non- smokers (83 days) with a p-value less than 0.01. 5. Almost 85% of the cases did not have any complications. One patient was operated on for bilateral clavicle fracture with 3.5 mm precontoured LCP but the patient had implant failure on both sides and was subsequently lost to follow-up. Out of the remaining 25 cases, only one had plate irritation while another had a prominent post- operative scar. Further, it is recommended to use a depth stop to prevent inadvertent injury to surrounding vital structures. 6. On the assessment of functional outcomes, all the patients had excellent outcomes at the end of six months. Further, early weight lifting with the affected limb must be strictly avoided to prevent early fixation failure. 7. It can be concluded that using 3.5 mm precontoured clavicular LCPs is a useful technique that can give good functional outcomes in displaced clavicular fractures. However, a large study with a longer follow-up is desirable to conclude it emphatically. |