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)

This study is not yet open for participant recruitment.

Verified by AO Clinical Investigation and Documentation, April 2009

First Received: April 3, 2009 No Changes Posted

Sponsor:	AO Clinical Investigation and Documentation
Collaborator:	Synthes Inc.
Information provided by:	AO Clinical Investigation and Documentation
ClinicalTrials.gov Identifier:	NCT00875992

Purpose

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.

Condition	Intervention
Tibial Fractures	Device: ETN with ASLS Device: ETN locked with conventional locking bolts

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Parallel Assignment, Efficacy Study
Official Title:	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)

Resource links provided by NLM:

MedlinePlus related topics: Fractures

U.S. FDA Resources

Further study details as provided by AO Clinical Investigation and Documentation:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	140
Study Start Date:	June 2009
Estimated Study Completion Date:	November 2011
Estimated Primary Completion Date:	July 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
ETN with ASLS: Experimental Angle stable locking of the Expert Tibial Nail using ASLS	Device: ETN with ASLS Angle stable locking of ETN using ASLS
ETN with conventional locking: Active Comparator Conventional locking of the Expert Tibial Nail using conventional locking bolts	Device: ETN locked with conventional locking bolts Conventional surgical procedure

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00875992

Contacts

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

Sponsors and Collaborators

AO Clinical Investigation and Documentation

Synthes Inc.

Investigators

Principal Investigator:

Dankward Hoentzsch, MD

BG Unfallklinik Tübingen, 72076 Tübingen, Germany

More Information

No publications provided

Responsible Party:	BG Unfallklinik Tübingen ( Prof. Dr. med. Dankward Höntzsch )
Study ID Numbers:	ASLS RCT 09
Study First Received:	April 3, 2009
Last Updated:	April 3, 2009
ClinicalTrials.gov Identifier:	NCT00875992 History of Changes
Health Authority:	Germany: Ethics Commission

Additional relevant MeSH terms:

Fractures, Bone
Wounds and Injuries
Disorders of Environmental Origin
Leg Injuries
Tibial Fractures

ClinicalTrials.gov processed this record on November 20, 2009