Home » Trials » SLCTR/2021/025


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

Sep 08, 2021



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

  1. Study site- Orthopedic wards of the North Colombo Teaching Hospital and National Hospital of Sri Lanka
  2. 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.
  3. Blinding- There will be no blinding as the surgeon and the patient must be aware of the treatment plan

Inclusion criteria

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

Exclusion criteria

  1. Patients who present more than 1 week after injury
  2. Patients whose fracture pattern requires a joint spanning external fixation
  3. Patients who are unable to consent
  4. 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

30


Countries of recruitment

Sri Lanka


Anticipated start date

2021-09-15


Anticipated end date

2021-12-31


Date of first enrollment


Date of study completion


Recruitment status

Pending


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


Results summary available

No


Date of posting results


Date of study completion


Final sample size


Date of first publication


Link to results


Brief summary of results