CTRI

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CTRI Number

CTRI/2024/05/067440 [Registered on: 15/05/2024] Trial Registered Prospectively

Last Modified On:

09/05/2024

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Surgical/Anesthesia

Study Design

Other

Public Title of Study

Outcome of metatarsal fractures treated with K wire fixation

Scientific Title of Study

Outcome of metatarsal fractures treated with intramedullary Kirschner wire fixation

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr Vatsal Patel
Designation	Resident doctor in Orthopaedics
Affiliation	Datta Meghe Institute of higher education and research
Address	Department of orthopaedics, Jawaharlal Nehru Medical College, Sawangi (Meghe), Wardha, Maharashtra, 442001, India Wardha MAHARASHTRA 442001 India
Phone	9586710308
Fax
Email	vatsalp1996@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Sanjay Deshpande
Designation	Professor
Affiliation	Datta Meghe Institute of higher education and research
Address	Department of orthopaedics, Jawaharlal Nehru Medical College, Sawangi (Meghe), Wardha, Maharashtra, 442001, India Wardha MAHARASHTRA 442001 India
Phone	9860452519
Fax
Email	svd1111@gmail.com

Details of Contact Person
Public Query

Name	Dr Sanjay Deshpande
Designation	Professor
Affiliation	Datta Meghe Institute of higher education and research
Address	Department of orthopaedics, Jawaharlal Nehru Medical College, Sawangi (Meghe), Wardha, Maharashtra, 442001, India MAHARASHTRA 442001 India
Phone	9860452519
Fax
Email	svd1111@gmail.com

Source of Monetary or Material Support

Orthopaedics Department, Jawaharlal Nehru Medical College, Sawangi Meghe, Wardha, Maharashtra 442001

Primary Sponsor

Name	JNMC
Address	Orthopaedics Department, Jawaharlal Nehru Medical College, Sawangi Meghe, Wardha, Maharashtra 442001
Type of Sponsor	Private medical college

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Vatsal Patel	Jawaharlal Nehru Medical College	Department of Orthopaedics, Sawangi(Meghe), Wardha, Maharashtra Wardha MAHARASHTRA	9586710308 vatsalp1996@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional Ethics Committee, Datta Meghe Institute of Higher Education and Research	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: S923\|\|Fracture of metatarsal bone(s), (2) ICD-10 Condition: O\|\|Medical and Surgical,

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	none	none
Intervention	Open/Close reduction and internal fixation with Kirschner wire for metatarsal fracture	Patients having metatarsal fractures will be assessed by x-rays and with all appropriate consents, fixation of fractures by K wire will be done.

Inclusion Criteria

Age From	15.00 Year(s)
Age To	90.00 Year(s)
Gender	Male
Details	1) Single or Multiple metatarsal fractures 2) Open or closed fractures

ExclusionCriteria

Details

1)Pathological fractures
2)Avulsion fractures
3)Stress fractures
4)Patients having pre-existing ipsilateral ankle, foot, knee and hip conditions

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
To analyze outcome of fractures of metatarsals treated with intramedullary fixation with Kirschner wire	AT 3 days, AT 2 weeks, AT 1 Â½ month, AT 3 month, AT 6 months

Secondary Outcome

Outcome	TimePoints
The secondary outcomes of the study includes analysis of fractures of Metatarsals in terms of 1) Radiological outcome 2) Functional outcome FAAM score and American orthopedic foot and ankle score	AT 3 days, AT 2 weeks, AT 1 Â½ month, AT 3 month, AT 6 months

Target Sample Size

Total Sample Size="30"
Sample Size from India="30"
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 3/ Phase 4

Date of First Enrollment (India)

24/07/2024

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="1"
Months="0"
Days="0"

Recruitment Status of Trial (Global)

Not Applicable

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

Patients coming to AVBRH department of Orthopaedics will be examined clinically and radiographic evaluationof foot Antero-posterior and oblique will be done. The patients diagnosed with having metatarsal fracture will be selected. Based on the inclusion and exclusion criteria, the selected patients for the study will be subjected to a proforma. Consents will be obtained from the selected study subjects. The consenting individuals will then be investigated based on routine investigations like CBC, KFT, LFT, RBS and PT-INR. Once the routine investivagtions are within normal range, the patients will either be managed with single or two k-wires fixation for metatarsal fracture. Closed or open reduction and K-wire fixation will be carried out in patients consenting for the study. Randomization will be utilized when sampling the patients. The patients will then be followed up at 3 days, 2 weeks, 6 weeks, 3 months and 6 months to evaluate the functional outcomes using FAAM and American orthopedic foot and ankle score and radiological outcomes.