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

January 22, 2013 updated by: AO Clinical Investigation and Publishing Documentation

A Randomized Controlled Trial to Evaluate the Effectiveness of Angular Stable Locking System (ASLS) in Patients With Distal Tibial Fractures Treated With Expert Tibial Nails (ETN)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The primary aim of the present study is to evaluate the effectiveness of the Angular Stable Locking System (ASLS) in patients with distal tibial fractures treated with Expert Tibial Nails (ETN). 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.

Study Type

Interventional

Enrollment (Actual)

141

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Innsbruck, Austria, 6020
        • Medizinische Universität
  • Germany
      • Berlin, Germany, 13353
        • Charité
      • Hannover, Germany, 30625
        • Medizinische Hochschule
      • Homburg/Saar, Germany, 66421
        • Universität des Saarlandes
      • Jena, Germany, 07740
        • Friedrich-Schiller-Universität
      • Mainz, Germany, 55131
        • Universitätsmedizin Mainz
      • Tübingen, Germany, 72076
        • BG Unfallklinik
  • Norway
      • Tonsberg, Norway, 3103
        • Sykehuset i Vestfold HF

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • The patient is ≥ 18 years old
  • The patient suffers from an acute distal third tibial fracture classified as:

AO 42 A1-A3, AO 42 B1-B3, AO 42 C1-C3, AO 43 A1-A3

  • The fracture is fixed with an Expert Tibia Nail (ETN)
  • The patient was able to walk without walking aid prior to the accident
  • 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 according to the CIP

Exclusion Criteria:

  • The patient is legally incompetent
  • Preexistent malunion or nonunion of the fracture under investigation
  • Osteotomies
  • The patient suffers from additional fractures of the lower extremities (Exception: ipsilateral fibular fracture)
  • The patient suffers from a pathologic fracture
  • The patient suffers from active malignancy
  • The patient is pregnant, breast feeding or planning to get pregnant during the study period
  • The patient suffers from a life-threatening condition
  • The patient is affected by drug or alcohol abuse
  • The patient has participated in any device related clinical trial affecting the lower extremities within the previous month
  • The patient has participated in any drug related clinical trial affecting bone healing within the previous month

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: ETN with ASLS
Angle stable locking of the Expert Tibial Nail using ASLS
Device: ETN with ASLS
Angle stable locking of ETN using ASLS
ACTIVE_COMPARATOR: ETN with conventional locking
Conventional locking of the Expert Tibial Nail using conventional locking bolts
Device: ETN locked with conventional locking bolts
Conventional surgical procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to pain free full weight bearing
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Amount of partial weight bearing
Time Frame: Up to achievement of primary outcome
Up to achievement of primary outcome

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AO Clinical Investigation and Publishing Documentation

Collaborators

Synthes Inc.

Investigators

  • Principal Investigator: Dankward Hoentzsch, MD, BG Unfallklinik Tübingen, 72076 Tübingen, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (ACTUAL)

August 1, 2012

Study Completion (ACTUAL)

December 1, 2012

Study Registration Dates

First Submitted

April 3, 2009

First Submitted That Met QC Criteria

April 3, 2009

First Posted (ESTIMATE)

April 6, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

January 23, 2013

Last Update Submitted That Met QC Criteria

January 22, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ASLS RCT 09

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Tibial Fractures

Clinical Trials on ETN with ASLS

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Gabon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe