Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000265471
Ethics application status
Not yet submitted
Date submitted
16/05/2007
Date registered
17/05/2007
Date last updated
2/09/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Echidna Pin Project: Clavicle Repair (Part 2)
Scientific title
To examine mid shaft clavicle fracture repair using the Echidna Pin with respect to: the time taken for healing and the shoulder function during and after healing and the assessment of pain during and after healing.
Secondary ID [1] 262975 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Repair of mid shaft clavicle fractures 1805 0
Condition category
Condition code
Injuries and Accidents 1893 1893 0 0
Fractures

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Echidna Pin repair will require a surgical operation of about 30 minutes, to implant an intramedullary bone pinning device to reduce and stabalise a fractured mid shaft clavicle until the bone has healed.
Intervention code [1] 1762 0
Treatment: Devices
Comparator / control treatment
Uncontrolled
Control group
Uncontrolled

Outcomes
Primary outcome [1] 2692 0
Radiographic assessment of healing of a fractured clavicle
Timepoint [1] 2692 0
At 6, 12, 26 & 52 weeks post intervention.
Secondary outcome [1] 4550 0
Time taken for healing
Timepoint [1] 4550 0
Assessed at radiographic time frames.
Secondary outcome [2] 4551 0
Pain during healing using Huskisson's visual analogue scale
Timepoint [2] 4551 0
Assessed at clinic visits at 6,12, 26 & 52 weeks post intervention.
Secondary outcome [3] 4552 0
Asymmetry of fractured shoulder v non fractured shoulder
Timepoint [3] 4552 0
Assessed prior to treatment and at 6 week clinic visit.
Secondary outcome [4] 4553 0
Shoulder function using constants functional assessment of the shoulder
Timepoint [4] 4553 0
Assessed prior to treatment, 1 day post treatment and 6,12,26 & 52 weeks post treatment.
Secondary outcome [5] 4554 0
Time to perform daily activities
Timepoint [5] 4554 0
Assessed at 6 and 12 weeks post treatment.
Secondary outcome [6] 4555 0
Time to return to work
Timepoint [6] 4555 0
Assessed at 6 and 12 weeks post treatment.
Secondary outcome [7] 4556 0
Length of stay in hospital
Timepoint [7] 4556 0
Assessed at 6 weeks post treatment.

Eligibility
Key inclusion criteria
Patients presenting after a traumatic incident, with a midshaft clavicle fracture, that is suitably sized to accept the intramedullary bone pin.
Minimum age
25 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with non-union, mal-union, infected or pathological fractures.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
not now necessary
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
not now necessary
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 2039 0
Commercial sector/Industry
Name [1] 2039 0
Echidna Surgical Solutions Proprietory Limited
Country [1] 2039 0
Australia
Primary sponsor type
Individual
Name
Elton Edwards
Address
Alfred Hospital Commercial Rd Prahan 3004 Vic
Country
Australia
Secondary sponsor category [1] 1847 0
Individual
Name [1] 1847 0
Ian Griggs
Address [1] 1847 0
78 Brice Ave Mooroolbark 3138
Country [1] 1847 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 3775 0
The Alfred Hospital Melbourne
Ethics committee address [1] 3775 0
Ethics committee country [1] 3775 0
Australia
Date submitted for ethics approval [1] 3775 0
01/11/2011
Approval date [1] 3775 0
Ethics approval number [1] 3775 0

Summary
Brief summary
Traditionally, non-displaced or minimally displaced clavicle fractures in the mid third of the clavicle have been treated non-operatively. The consensus has been that they all heal. Many displaced mid-shaft clavicle fractures are treated non-operatively as well, but these fractures tend to heal with varying degrees of cosmetic deformity, because the fracture ends over-ride, typically causing a bump under the skin at the fracture site. Until now, the surgical scar from operative repair has been equally if not more displeasing cosmetically for the patient.

Hill et al found non-unions in 15% of his patients with non-surgical treatment. He reported a clear correlation with shortenings of more than 2cm. At follow up of 157 patients, Matis et al found appreciable deterioration of shoulder function in half of the cases, showing clavicular shortening of 1cm; in cases in which clavicular shortening was 2cm or more deterioration was considerable.
While most patients with a middle-third clavicle fracture will heal in a nonanatomic position, it is conceivable that elite competitive or professional athletes who engage in overhead or throwing activities, may not do well with a malunited clavicle. Consequently, treatment recommendations must be individualized. Neurovascular complications associated with non-union, including subclavian artery and vein compression, thoracic outlet syndrome, and brachial plexus palsy, have also been reported.

A variable degree of malunion is present in displaced fractures of the middle clavicle, resulting in a permanent visible prominence over the fracture site, with related shortening of the clavicle and concurrent biomechanical disadvantage. Many authors suggest that such malunion results in acceptable function. This is of particular concern cosmetically and emotionally to people who cannot carry shoulder bags or who find it uncomfortable to carry a backpack over the affected area. As a result of the shortening and dropping of the shoulder, the thin straps of clothing can slip off, and low cut attire reveals a prominent cosmetic lump defect. Discomfort can also be experienced when car seat belts are worn. Economic losses whilst waiting for fracture healing, are due to restrictions on employment or non-training/competing time for athletes. There is also discomfort during daily activities with uncomfortable and painful sleeping postures, causing loss of sleep. Rowe reported that midclavicular fractures in adults were often underrated with regard to pain and disability during the first three weeks. In a review of 118 patients with clavicle fractures followed for 2 years, Eskola et al found that 27 (23%) had pain or limited motion with exercise, and 4 (3%) had major functional problems.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27865 0
Address 27865 0
Country 27865 0
Phone 27865 0
Fax 27865 0
Email 27865 0
Contact person for public queries
Name 10951 0
Ian Griggs
Address 10951 0
78 Brice Ave
Mooroolbark VIC 3138
Country 10951 0
Australia
Phone 10951 0
+61 3 97267089
Fax 10951 0
Email 10951 0
[email protected]
Contact person for scientific queries
Name 1879 0
Ian Griggs
Address 1879 0
78 Brice Ave
Mooroolbark VIC 3138
Country 1879 0
Australia
Phone 1879 0
+61 3 97267089
Fax 1879 0
Email 1879 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.