ANZCTR - Registration

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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]

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

Condition category

Condition code

Injuries and Accidents

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]

Treatment: Devices

Comparator / control treatment

Uncontrolled

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Radiographic assessment of healing of a fractured clavicle

Timepoint [1]

At 6, 12, 26 & 52 weeks post intervention.

Secondary outcome [1]

Time taken for healing

Timepoint [1]

Assessed at radiographic time frames.

Secondary outcome [2]

Pain during healing using Huskisson's visual analogue scale

Timepoint [2]

Assessed at clinic visits at 6,12, 26 & 52 weeks post intervention.

Secondary outcome [3]

Asymmetry of fractured shoulder v non fractured shoulder

Timepoint [3]

Assessed prior to treatment and at 6 week clinic visit.

Secondary outcome [4]

Shoulder function using constants functional assessment of the shoulder

Timepoint [4]

Assessed prior to treatment, 1 day post treatment and 6,12,26 & 52 weeks post treatment.

Secondary outcome [5]

Time to perform daily activities

Timepoint [5]

Assessed at 6 and 12 weeks post treatment.

Secondary outcome [6]

Time to return to work

Timepoint [6]

Assessed at 6 and 12 weeks post treatment.

Secondary outcome [7]

Length of stay in hospital

Timepoint [7]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Echidna Surgical Solutions Proprietory Limited

Address [1]

78 Brice Ave Mooroolbark 3138

Country [1]

Australia

Primary sponsor type

Individual

Name

Elton Edwards

Address

Alfred Hospital Commercial Rd Prahan 3004 Vic

Country

Australia

Secondary sponsor category [1]

Individual

Name [1]

Ian Griggs

Address [1]

78 Brice Ave Mooroolbark 3138

Country [1]

Australia

Ethics approval

Ethics application status

Not yet submitted

Ethics committee name [1]

The Alfred Hospital Melbourne

Ethics committee address [1]

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

01/11/2011

Approval date [1]

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Ian Griggs

Address

78 Brice Ave
Mooroolbark VIC 3138

Country

Australia

Phone

+61 3 97267089

Fax

echidnapins@bigpond.com

Contact person for scientific queries

Name

Ian Griggs

Address

78 Brice Ave
Mooroolbark VIC 3138

Country

Australia

Phone

+61 3 97267089

Fax

echidnapins@bigpond.com

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.

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