Early mobilization vs delayed mobilisation following the use of a volar locking plate with non-vascularised bone graft in scaphoid non-union. A multicentred randomised controlled-trial.

In patients with scaphoid non-union is early mobilisation or delayed mobilisation post open reduction and internal fixation (ORIF) more effective in achieving union of fracture? A multicentred randomised controlled trial.

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12614001050640

Enrollment

Registered

2014-10-02

Start date

2014-11-01

Completion date

2016-01-01

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

This is a randomised controlled trial analysing two rehabilitation techniques for non-union scaphoid fractures. This study aims to investigate whether the use of an anatomically contoured scaphoid specific locking plate with non-vascularised bone graft in scaphoid non-union allows for early mobilisation and union. This study will be conducted as a randomised controlled trial with the control arm receiving the gold standard rehabilitation (1) and the experimental arm receiving no plaster and early mobilisation. Our hypothesis is there will be no difference in union rates between the gold standard and experimental cohorts. We are hoping this will result in a change in standard practice for this group of patients.

Interventions

All patients will undergo an open reduction internal fixation using an anatomically contoured scaphoid specific locking plate with non-vascularised bone graft. The surgery will take approximately 1 hr. The intervention group will be able to mobilise post-operatively. A bulky dressing will be applied (velband and crepe). This will be removed at the 2 week wound review.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to 90 Years

Healthy volunteers

Inclusion criteria

All adult patients (age >18yrs) with established non-union scaphoid fractures will be considered for inclusion. Non-union will be defined as a persistence of radiological evidence of non-union 3 months from injury date on either x-ray or CT imaging.

Exclusion criteria

Patients who have had a previous failed open reduction, internal fixation procedure.

Outcome results