Slctr

Pilot Study to assess safety of new Low Cost External Fixators for Long bone fractures

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SLCTR Registration Number

SLCTR/2021/025

Date of Registration

06 Sep 2021

The date of last modification

Jun 24, 2022

Application Summary

Scientific Title of Trial

Pilot Study to assess safety of new Low Cost External Fixators for Long bone fractures

Public Title of Trial

Pilot study to assess the safety of a newly designed external fixator (MK03) among patients who present with compound fractures of the tibia

Disease or Health Condition(s) Studied

Compound fractures of tibia

Scientific Acronym

None

Public Acronym

None

Brief title

None

Universal Trial Number

U1111-1268-6582

Any other number(s) assigned to the trial and issuing authority

P/12/02/2021 - Ethics Review Committee of the Faculty of Medicine, University of Kelaniya

Trial Details

What is the research question being addressed?

What are the safety and mechanical stability outcomes of a novel external fixator in the management of compound fractures of the tibia

Type of study

Interventional

Study design

Allocation

Single arm study

Masking

Masking not used

Control

Uncontrolled

Assignment

Single

Purpose

Treatment

Study Phase

Phase 1

Intervention(s) planned

Study site- Orthopedic wards of the North Colombo Teaching Hospital and National Hospital of Sri Lanka
Intervention- The MK03 external fixator will be the new device used. When a patient is admitted with an open fracture of the tibia, which needs to be stabilized, the MK03 fixator will be applied. The fixator will be kept until the definitive soft tissue cover and fracture fixation is achieved. The final decision to use the MK03 fixator is decided by the surgeon based on the fracture pattern, soft tissue loss and the optimum treatment for the patient.
Blinding- There will be no blinding as the surgeon and the patient must be aware of the treatment plan

Inclusion criteria

Patients aged 18 years and above
Patients who present with compound fractures of the tibia

Exclusion criteria

Patients who present more than 1 week after injury
Patients whose fracture pattern requires a joint spanning external fixation
Patients who are unable to consent
Patients who are immunocompromised or with conditions which delay wound healing.(E.g malignancy, liver, renal disease, on steroids etc)

Primary outcome(s)

1. Pin site infection will be graded based on the severity scale for pin site infection – Checketts-Otterburn classification	[ 2,4,6,8 and 12 weeks ]
2. Pin loosening – This is a clinical assessment which has a binary, ‘Yes’ or ‘No’ value	[ 2,4,6,8 and 12 weeks ]
3. Stability of the construct - This is a clinical assessment which has a binary, ‘Yes’ or ‘No’ value	[ 2,4,6,8 and 12 weeks ]
4. Progression of soft tissue healing – Based on the final treatment – a. Primary closure achieved b. Delayed primary closure achieved c. Closure with skin graft d. Local tissue transfer e. Free tissue transfer f. Amputation	[ 2,4,6,8 and 12 weeks ]
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Secondary outcome(s)

1. Evidence of deformed clamp sites:Visual inspection using pre and post images. The image will be taken in the Orthogonal view to the clamp axis for this purpose. Binary scale (“Yes”/”No”) will be used to measure the outcome	[ 2,4,6,8 and 12 weeks ]
2. Evidence of damage to any fixator, measured by visual inspection using pre and post images. The image will be taken in the Orthogonal view to the clamp axis for this purpose. Binary scale (“Yes”/”No”) will be used to measure the outcome	[ 2,4,6,8 and 12 weeks ]
3. Extent of fixator slippage between interfaces:Measured by orthogonal x rays taken immediately post op and during follow up will be used. By comparing orthogonal x ray, with the previous x ray, any change in position of the screws, clamps and rods, in axial, sagittal and coronal planes can be compared. This will be an indicator of evidence of fixator slippage	[ 2,4,6,8 and 12 weeks ]
4. Extent of deformed rods, measured using visual inspection using pre and post images.	[ 2,4,6,8 and 12 weeks ]
5. Evidence of any surface damage in the composite connecting rod at the clamping locations:Measured by visual inspection using pre and post images	[ 2,4,6,8 and 12 weeks ]
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Target number/sample size

Countries of recruitment

Sri Lanka

Anticipated start date

2021-09-15

Anticipated end date

2021-12-31

Date of first enrollment

2021-09-15

Date of study completion

Recruitment status

Recruiting

Funding source

NIHR Global Health Research Group on Post Conflict Trauma (“PrOTeCT”)” and quote the reference P67348

Regulatory approvals

Not applicable

State of Ethics Review Approval

Status

Approved

Date of Approval

2021-06-22

Approval number

P/12/02/2021

Details of Ethics Review Committee

Name:	Ethics Review Committee of the Faculty of Medicine, University of Kelaniya.
Institutional Address:	Ethics Review Committee, Faculty of Medicine, University of Kelaniya, P.O Box 6, Thalagolla Road, Ragama, Sri Lanka
Telephone:	0112961267
Email:	erckelaniya@gmail.com

Contact & Sponsor Information

Contact person for Scientific Queries/Principal Investigator

Dr. Pujitha Silva
Senior Lecturer
Department of Biomedical Engineering, University of Moratuwa

0770527954

psilva@uom.lk

Contact Person for Public Queries

Dr. Pujitha Silva
Senior Lecturer
Department of Biomedical Engineering, University of Moratuwa

0770527954

psilva@uom.lk

Primary study sponsor/organization

Imperial College London

London SW7 2BX, United Kingdom

Secondary study sponsor (If any)

Trial Completion details

Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?

Yes

IPD sharing plan description

Individual participant data that underlie the results being reported, will be shared after de-identification (text, tables, figures and appendices)

Study protocol available

Yes

Protocol version and date

Version 2.1, Date 07.06.2021

Protocol URL

Not available

Results summary available

Date of posting results

Date of study completion

Final sample size

Date of first publication

Link to results

Brief summary of results

Trial Options

Pilot Study to assess safety of new Low Cost External Fixators for Long bone fractures -

Application Summary

Trial Details

State of Ethics Review Approval

Contact & Sponsor Information

Trial Completion details

Pilot Study to assess safety of new Low Cost External Fixators for Long bone fractures

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