Skip to content

Should Ankle Syndesmosis Screws be Removed? - Medium Term Outcomes with a Minimum of Five Years Follow-up

Should Ankle Syndesmosis Screws be Removed? - Medium Term Follow-up Comparing Screw Retention with Screw Removal Following Ankle Fracture Fixation

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12618001971224
Acronym
ASSET - Ankle Syndesmosis Screw Extended Term Follow-up Study
Enrollment
62
Registered
2018-12-06
Start date
2020-01-01
Completion date
2020-11-01
Last updated
2019-11-25

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

Conditions

None listed

Brief summary

Certain ankle fractures require surgical fixation, with a subset of these ankle fractures also requiring screw fixation of syndesmotic ligamentous injuries. 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. In 2014, we published an article in the Bone and Joint Journal, demonstrating that there is no difference in removing or retaining ankle syndesmosis screws at one-year follow-up. At the time of publication, our study, entitled “Removal of the syndesmotic screw after the surgical treatment of a fracture of the ankle in adult patients does not affect one-year outcomes”, was voted by the American Academy of Orthopaedic Surgeons (AAOS) as one of the top 15 studies (from a cohort of 856 studies) most likely to impact Orthopaedic Surgeons’ practice in the world. One of the limitations in our initial study was the short duration of follow-up of one year. The aim of this current study is to review the patients who participated in the initial study and assess the medium-term outcomes in these patients. At the time of follow-up, we will have a minimum of five years follow-up results from this patient cohort.

Interventions

Our intervention group is of those patents who did not have a removal of ankle syndesmosis screws. We are reviewing their outcomes five years post surgery with their screw still in situ in a clinical setting where we will assess patients outcomes using various scoring systems and repeat xrays of their ankles as well as retrospective review their electronic hospital clinical notes and imaging over the past 5 years to determine any complications prior to our 5-year follow-up.

Sponsors

Middlemore Hospital
Lead SponsorHospital

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

Patients will be identified from the previous study database from the original randomised control trial (Boyle, M, Gao, R, Frampton, C et al. Removal of the syndesmotic screw after the surgical treatment of a fracture of the ankle in adult patients does not affect one-year outcomes (2014) Bone and Joint Journal. 96 (12).) and invited by telephone to return for follow-up. Our original inclusion criteria were patients who were between the ages of 16 and 65 with a displaced fibular fracture with associated tibiofibular diastasis.

Exclusion criteria

Our original exclusion criteria was open fractures, preceding ankle abnormality, neurovascular injury, plafond injury or posterior maleollar fracture involving >10% of joint surface, polytrauma, diaphysial tibia fracture, pathological fracture, cognitive impairment or pregnancy.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026