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Malreduction of Syndesmosis and Outcomes Following Trans-syndesmotic Screw versus Suture Button Fixation under Direct Visualization and Reduction Technique: A Prospective Randomized Controlled Study

Malreduction of Syndesmosis and Outcomes Following Trans-syndesmotic Screw versus Suture Button Fixation under Direct Visualization and Reduction Technique: A Prospective Randomized Controlled Study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
TCTR
Registry ID
TCTR20191205002
Enrollment
Unknown
Registered
2019-12-05
Start date
2018-01-12
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Acute ankle fracture with syndesmotic injury Ankle fracture syndesmotic malreduction syndesmotic screw fixation suture button

Interventions

Syndesmotic screw fixation,Suture button fixation
Active Comparator Procedure/Surgery,Active Comparator Procedure/Surgery

Sponsors

Mahavajiralongkorn
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: Age more than 18 years old who had ankle fracture with syndesmotic injury within 4 weeks from onset of injury. Complete pre- and post-operative outcomes measurement.

Exclusion criteria

Exclusion criteria: Diabetic foot with poor control Peripheral neuropathy Unable to follow-up for at least 6months Concomitant adjacent fractures.

Design outcomes

Primary

MeasureTime frame
To compare syndesmotic malreduction rate and outcomes between trans-syndesmotic screw versus suture 3,6,12 month Compare mean two groups dependent analysis 95% Confidence Interval α = 0.05, β = 0.10 Level of si—

Secondary

MeasureTime frame
Complications Functional outcomes VAS SF-36 (PCS and MCS) FAAM (ADL and Sport) Tibiofibular overlap 3,6,12 month Malreduction define as the anterior distal tibiofibular distance > 2mm—

Countries

thailand

Contacts

Public ContactSuthavee Pangkanon

-

thai_taxas_s@hotmail.com0836165454

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026