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Echidna Pin Project: Clavicle Repair (Part 2)

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.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12607000265471
Enrollment
10
Registered
2007-05-17
Start date
2011-11-01
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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.

Sponsors

Elton Edwards
Lead SponsorIndividual

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
25 Years to 55 Years
Healthy volunteers
No

Inclusion criteria

Patients presenting after a traumatic incident, with a midshaft clavicle fracture, that is suitably sized to accept the intramedullary bone pin.

Exclusion criteria

Patients with non-union, mal-union, infected or pathological fractures.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026