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Non-randomized controlled trial on the stability and outcome of the conventional wrist-spanning external fixator versus an invented low cost wrist-spanning radio-metacarpal external fixator for comminuted displaced distal radius fractures -

SLCTR Registration Number

SLCTR/2017/009


Date of Registration

28 Mar 2017

The date of last modification

Mar 28, 2017



Application Summary


Scientific Title of Trial

Non-randomized controlled trial on the stability and outcome of the conventional wrist-spanning external fixator versus an invented low cost wrist-spanning radio-metacarpal external fixator for comminuted displaced distal radius fractures


Public Title of Trial

Research study comparing the effectiveness of a new device used for a type of wrist fractures


Disease of Health Condition(s) Studied

Distal Radius Fractures


Scientific Acronym

None


Public Acronym

None


Brief title

None


Universal Trail Number

U1111-1186-4791


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

ERC/015/021 (ERC:SLMA)


Trial Details


What is the research question being addressed?

What is the stability and outcome of an invented low cost wrist-spanning radio-metacarpal external fixator compared to the conventional wrist-spanning external fixator in patients with comminuted displaced distal radius fractures?


Type of study

Interventional


Study design

Allocation

Non-randomized controlled trial


Masking

Masking not used


Control

Historical


Assignment

Other


Purpose

Treatment


Intervention(s) planned

Study setting: Designated Orthopaedic Unit (Dr. R. Sooriyarachchi, Consultant Orthopaedic Surgeon), National Hospital of Sri Lanka.

Experimental / Study group: Patients admitting with severely comminuted and displaced distal radius fractures where external fixation is indicated

Control group: Patients who were managed according to standard protocols in the Orthopaedic Unit, with the existing external fixators designed for distal radius fractures during the preceding 1 year of period, matched to the characteristics of the study group.

All participants will receive supportive care in accordance with standard unit protocols


Inclusion criteria

  1. Age 18 years or above
  2. Severely comminuted and displaced distal radius fractures (diagnosed by AP + lateral x-ray)

Exclusion criteria

  1. Skeletally immature patients where age is less than 18 years


Primary outcome(s)

  1. Presence of pain at wrist with movement while on external fixator (assessed using a 5 point scale)
  2. Presence of pin-site infections – Grade 4,5,6 (Checketts–Otterburn classification
  3. Presence of significant wrist joint stiffness with reduced range of movement by 50% or more (< 750) on clinical examination
  4. Radial height being less than 2mm (radiological examination)
  5. Radial length being less than 8mm (radiological examination)
  6. Radial inclination being less than 100 (radiological examination)
  7. Negative value for volar tilt (on radiological examination)
  8. Intra-articular step more than 2mm (radiological examination)

Primary outcome(s) - Time of assessment(s)

At week 1,4,6 and 12 post-operatively


Secondary outcome

None


Secondary outcome(s) - Time of assessment(s)

None



Target number/sample size

168 (84 in the intervention arm and 84 matched historical controls)


Countries of recruitment

Sri Lanka


Anticipated start date

2018-02-01


Anticipated end date

2019-01-30


Recruitment status

Pending


State of ethics review approval

Approved by the Ethics Review Committee, Sri Lanka Medical Association on 24th October 2016 (Ref: ERC/015/021)


Funding source

None



Contact & Sponsor Information


Contact person for Scientific Queries/Principal Investigator

G.A.L. Niroshana
Registrar in Orthopedic Surgery
Orthopedic Unit National Hospital of Sri Lanka Colombo 00800 Sri Lanka
Tel: 0112-691111
Mob: 0772-605841

lamindu@yahoo.com

Contact Person for Public Queries

Dr R Sooriyarachchi
Consultant Orthopaedic Surgeon
Orthopaedic Unit National Hospital of Sri Lanka Colombo 00800 Sri Lanka
Tel: 0112-691111
Mob: O777600600

ruksoo@gmail.com


Primary study sponsor/organization

Orthopedic Unit, National Hospital of Sri Lanka

Colombo 00800 Sri Lanka
Tel: 0112691111 (Ext – 2274)
Fax: 0112698443

www.nhsl.health.gov.lk

Secondary study sponsor (If any)

None