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Non--operative Treatment of the Medial Malleolus in bi- and Trimalleolar Ankle Fractures

Non--operative Treatment of the Medial Malleolus in bi- and Trimalleolar Ankle Fractures. A Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01441817
Enrollment
100
Registered
2011-09-28
Start date
2002-05-31
Completion date
2008-08-31
Last updated
2011-09-28

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

Conditions

Ankle Malleolus Fracture Bimalleolar, Fracture of Medial Malleolus, Fracture of Ankle

Brief summary

The purpose of this study was to determine if internal fixation of the medial malleolus is necessary following open reduction and internal fixation of the lateral and, if required, the posterior malleolus treating displaced bi-or trimalleolar ankle fractures.

Interventions

Internal fixation of the medial malleolus following open reduction and internal fixation of the lateral and, if required, posterior malleolus.

Sponsors

Oslo University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients with Orthopaedic Trauma Association (OTA) type 44 fractures (B2-3 and C2-3).

Exclusion criteria

* Patients with OTA type 43 distal tibia fractures. * Patients with soft tissue injuries involving the medial malleolus.

Design outcomes

Primary

MeasureTime frame
American Orthopaedic Foot and Ankle Society ankle hind foot score (AOFAS)Average of 42 months
The Olerud Molander Ankle score (OMAS)Average of 42 months

Secondary

MeasureTime frameDescription
Posttraumatic osteoarthritis (OA) according to the criteria of Magnusson (stage I-IV)Average of 42 months
VAS scoreAverage of 42 monthsPain evaluated at rest, in the morning, in the evening and during the night.

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026