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Removal versus retention of the syndesmotic stabilisation screw in the ankle: a randomized controlled trial.

Removal versus retention of the syndesmotic stabilisation screw in the ankle: a randomized controlled trial. - REVERSE; REmoval VErsus Retention of the Syndesmotic screw, an Evaluation

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON37528
Enrollment
100
Registered
2012-09-28
Start date
2012-09-01
Completion date
Unknown
Last updated
2024-04-29

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

Conditions

ankle fracture syndesmotic instability

Interventions

In one group the syndesmotic screw will be routinely removed 8 weeks after placement. In the other group the screw will be retained indefinitely and only removed if symptomatic.

Sponsors

Spaarne Ziekenhuis
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - patients >18 years and under 70 years - acute traumatic syndesmotic instability, operatively treated with a stabilization screw

Exclusion criteria

Exclusion criteria: - patients 16) - patients with additional traumatic injuries to the affected leg that could influence ankle function - patients with a neurologic disorder of the lower extremity - likely problems with maintaining follow up or understanding Dutch questionnaires

Design outcomes

Primary

MeasureTime frame
The main study parameter is the difference in AOFAS ankle and hindfoot score.—

Secondary

MeasureTime frame
Other outcome parameters are a pain score (VAS), the OMAS, a quality of life score (SF-12), radiologic evaluation, range of motion, adverse events, and time to resume to normal activities such as work and sports.—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)