The main objective of the study is to compare the routinely removal versus retainment of the syndesmotic stabilization screw.
ID
Source
Brief title
Condition
- Tendon, ligament and cartilage disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the difference in AOFAS ankle and hindfoot score.
Secondary outcome
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.
Background summary
Syndesmotic stabilization is mostly performed using a metal syndesmotic
stabilization screw. The routinely removal or retainment of this screw has been
subject to debate. None of these treatments have proven to be superior.
Retaining the screw could lead to breakage and loosening of the screw of which
the clinical consequences are not yet clear. With routinely removal however, a
second operation with the additional costs and risk of complications is needed.
Study objective
The main objective of the study is to compare the routinely removal versus
retainment of the syndesmotic stabilization screw.
Study design
A randomized controlled trial.
Intervention
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.
Study burden and risks
The burden associated with participation is an increased number of subjective
scores to fill out, and increased number of (non-invasive) measurements of the
kinematics of the foot and ankle in addition to a further normal treatment and
after-treatment pattern for both methods. The risks associated are not
increased, for both methods are widely used and none is so far proven superior.
Spaarnepoort 1
Hoofddorp 2134 TM
NL
Spaarnepoort 1
Hoofddorp 2134 TM
NL
Listed location countries
Age
Inclusion criteria
- patients >18 years and under 70 years
- acute traumatic syndesmotic instability, operatively treated with a stabilization screw < 1 week after trauma
- correct open reduction and internal fixation of the ankle fracture based on post-operative x-ray
- able and willing to give written informed consent
Exclusion criteria
- patients <18 years or over 70 years
- no metal stabilization screw used
- syndesmotic stabilization with other stabilization methods
- patients with multiple trauma (ISS>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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL39059.094.12 |