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Status:

COMPLETED

Evaluation of Handling and Possible Complications Related to the Newly Developed Angular Stable Locking System (ASLS)

Lead Sponsor:

AO Clinical Investigation and Publishing Documentation

Collaborating Sponsors:

Synthes Inc.

Conditions:

Humerus Fracture

Femur Fracture

Eligibility:

All Genders

18+ years

Brief Summary

In many cases, the existing locking bolts and screws in intramedullary nails do not provide sufficient stability. Due to the play between screw and nail, the reduction can be lost and the instability ...

Eligibility Criteria

Inclusion

  • Inclusion Criteria:
  • The patient is ≥ 18 years old
  • One of the following bones is fractured so that the fracture is affecting the proximal or the distal third of the bone without affecting the joint surface: Humerus, Femur, Tibia
  • The fracture is fixed with one of the following cannulated implants Humerus: Expert HN, Expert PHN. Femur: Expert LFN, Expert RAFN, CFN, DFN, AFN. Tibia: Expert TN, CTN.
  • The patient is willing and able to participate in the study follow-up according to the CIP.
  • The patient is able to understand and read local language at elementary level.
  • The patient is willing and able to give written informed consent to participate in the study.
  • Exclusion criteria:
  • The patient is legally incompetent.
  • Preexistent malunion or nonunion of the bone that is planned to be treated with ASLS.
  • The patient suffers from a polytrauma (multiple injuries, whereof one or the combination of several injuries is life-threatening).
  • The patient suffers from active malignancy.
  • The patient is affected by drug or alcohol abuse.
  • The patient has participated in any other device or drug related clinical trial within the previous month.

Exclusion

    Key Trial Info

    Start Date :

    August 1 2008

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ESTIMATED

    End Date :

    August 1 2009

    Estimated Enrollment :

    30 Patients enrolled

    Trial Details

    Trial ID

    NCT00793637

    Start Date

    August 1 2008

    End Date

    August 1 2009

    Last Update

    July 22 2021

    Active Locations (4)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 1 (4 locations)

    1

    Medizinische Universität Innsbruck, Abteilung Unfallchirurgie und Sporttraumatologie

    Innsbruck, Austria, 6020

    2

    Charité - Universitätsmedizin Berlin, Centrum für Muskuloskeletale Chirurgie

    Berlin, Germany, 13353

    3

    Universitätsklinikum Mainz, Klinik und Poliklinik für Unfallchirurgie

    Mainz, Germany, 55131

    4

    BG Unfallklinik Tübingen

    Tübingen, Germany, 72076