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Trial to Evaluate the Effectiveness of Angular Stable Locking System (ASLS) in Patients With Distal Tibial Fractures

NCT00875992 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 141

Last updated 2013-01-23

No results posted yet for this study

Summary

In many cases, the existing locking bolts and screws in intramedullary nails do not provide sufficient stability. The play between screw and nail can result in loss of reduction and the instability due to the interfragmentary movement can result in malunions or nonunions. Therefore, an Angular Stable Locking System for Intramedullary Nails (ASLS) was developed to enhance axial and angular fracture stability. ASLS provides angular-stable fixation between nails and screws with resorbable sleeves used as dowels in the nail locking holes. Preliminary results of a pre-study show a trend towards reduced time to pain-free full weight bearing in patients being treated with ASLS. This hypothesis will be tested in the present randomized controlled study.

Conditions

  • Tibial Fractures

Interventions

DEVICE

ETN with ASLS

Angle stable locking of ETN using ASLS

DEVICE

ETN locked with conventional locking bolts

Conventional surgical procedure

Sponsors & Collaborators

  • Synthes Inc.

    collaborator INDUSTRY

  • AO Clinical Investigation and Publishing Documentation

    lead OTHER

Principal Investigators

  • Dankward Hoentzsch, MD · BG Unfallklinik Tübingen, 72076 Tübingen, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2012-08-31
Completion
2012-12-31

Countries

  • Austria
  • Germany
  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00875992 on ClinicalTrials.gov