Trial to Evaluate the Effectiveness of Angular Stable Locking System for Intramedullary Nails (ASLS) in Patients With Distal Tibial Fractures Treated With Expert Tibial Nails (ETN) - Tabular View

Tracking Information

First Received Date ^ICMJE

April 3, 2009

Last Updated Date

April 3, 2009

Start Date ^ICMJE

June 2009

Estimated Primary Completion Date

July 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Time to pain free full weight bearing [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Amount of partial weight bearing [ Time Frame: Up to achievement of primary outcome ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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)

Brief 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.

Detailed Description

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Single Blind (Subject), Parallel Assignment, Efficacy Study

Condition ^ICMJE

Tibial Fractures

Intervention ^ICMJE

Device: ETN with ASLS
Device: ETN locked with conventional locking bolts

Study Arms / Comparison Groups

Experimental: Angle stable locking of the Expert Tibial Nail using ASLS
Active Comparator: Conventional locking of the Expert Tibial Nail using conventional locking bolts

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

140

Estimated Completion Date

November 2011

Estimated Primary Completion Date

July 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Denise Schmid	+41 (0) 44 200 24 77	Denise.Schmid@aofoundation.org
Contact: Peter Langer, PhD	+41 (0) 44 200 24 68	Peter.Langer@aofoundation.org

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00875992

Responsible Party

Prof. Dr. med. Dankward Höntzsch, BG Unfallklinik Tübingen

Study ID Numbers ^ICMJE

ASLS RCT 09

Study Sponsor ^ICMJE

AO Clinical Investigation and Documentation

Collaborators ^ICMJE

Synthes Inc.

Investigators ^ICMJE

Principal Investigator:

Dankward Hoentzsch, MD

BG Unfallklinik Tübingen, 72076 Tübingen, Germany

Information Provided By

AO Clinical Investigation and Documentation

Verification Date

April 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP