Should ankle syndesmosis screws be removed? A randomised, controlled trial.

In patients with syndesmosis screw fixation for ankle fracture diastasis, is removal of the syndesmosis screws at 3 months post surgery more effective than no screw removal in terms of functional outcomes?

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12611000397910

Enrollment

100

Registered

2011-04-15

Start date

2011-08-24

Completion date

2012-11-30

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

Screw stabilisation of the disrupted ankle syndesmosis maintains reduction as healing of the distal tibiofibular ligaments occurs. It has previously been thought that syndesmosis screws may contribute to ankle dysfunction by restricting the normal motion between the tibia and fibula. Screw removal, breakage, or loosening may restore motion but can permit loss of reduction if these occur before complete ligamentous healing. As a result, although some well-established principles exist for reduction and surgical treatment of syndesmotic injuries, there remains controversy regarding whether routine syndesmosis screw removal is desirable. We plan to conduct a prospective, randomized, controlled trial to investigate the outcomes of patients with ankle syndesmosis screws left in situ and compare these with the outcomes of patients with removed syndesmosis screws. To date, there have been no randomised, controlled trials comparing these two patient groups.

Interventions

No removal of ankle syndesmosis screws.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

16 Years to 65 Years

Healthy volunteers

Inclusion criteria

Male or female patients; greater than or equal to 16 years of age; ankle fracture with diastasis for planned syndesmosis screw fixation; AP, lateral and mortise X-ray views of the ankle taken preoperatively; closed fractures; consent form signed.

Exclusion criteria

Ankle fractures not requiring syndesmosis screw fixation; compound fractures; pathologic fractures; fracture in a polytraumatised patient; fracture of a bone in the same lower limb (other than ankle fracture complex); patients > 65 years of age; past history of fracture or significant injury or disability of the same ankle; medical conditions too serious for surgery; patients who are unfit to consent; pregnant women.

Outcome results