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Outcome Following Semitubular Plate vs. Polyaxial Locking Plates

a Prospective Randomized Study on the Outcome Following Osteosynthesis of Distal Fibula Fracture Using Semitubular Plate in AO Technique vs. Polyaxial Locking Plates

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04370561
Enrollment
45
Registered
2020-05-01
Start date
2016-01-01
Completion date
2019-01-01
Last updated
2020-05-05

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

Conditions

Ankle Fractures

Brief summary

In this prospective study, all patients with distal fibula fractures (AO 44 B1.1, B1.2, B1.3), with indication for surgery were included. Patients were randomized to either the DePuy Synthes® one-third semitubular plate (Group I) or NEWCLIP TECHNICS, Active Ankle® polyaxial locking plate (Group II). In Group II early weight bearing was allowed after two weeks postoperatively. Primary outcome parameter was function of the ankle joint, assessed by the Olerud and Molander ankle score (OMAS), Foot and Ankle outcome score (FAOS) and Karlsson and Peterson Scoring System for Ankle function (KPSS). Secondary outcome parameter were postoperative complications. Superficial wound infection, delayed wound healing, mechanically prominent implant, skin irritations were considered as minor and deep wound infection, material loosening, loss of reduction were regarded as major complications requiring revision surgery. Clinical and radiological follow-up were performed 6 and 12 weeks, 6 months and 1 year postoperatively.

Interventions

PROCEDUREORIF non-locking

Open reduction and internal fixation using 1/3 tubular plate

PROCEDUREORIF locking

Open reduction and internal fixation using active ankle polyaxial locking plate

Sponsors

Technical University of Munich
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* age between 18 and 65 years * Fracture of the distal fibula (AO 44 B1.1, B1.2, B1.3) * Written informed consent

Exclusion criteria

* Pregnancy * mental disorders * comprehensive legal support. * pathological and/or osteoporotic fracture * open fracture

Design outcomes

Primary

MeasureTime frameDescription
Ankle function12 monthClinical objective ankle function assessed by Olerud and Molander ankle score (OMAS)

Secondary

MeasureTime frameDescription
Ankle function12 monthClinical objective ankle function assessed by Foot and Ankle outcome score (FAOS)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026