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

Tibial Fractures Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00875992
• Other study ID #: ASLS RCT 09
• Status: Completed
• Phase: N/A
• First received: April 3, 2009
• Last updated: January 22, 2013
• Start date: June 2009
• Est. completion date: December 2012

Study information

• Verified date: January 2013
• Source: AO Clinical Investigation and Documentation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics CommissionAustria: EthikkommissionNorway: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 141
• Est. completion date: December 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fractures, Bone
• Tibial Fractures

Intervention

Device:
• ETN with ASLS
Angle stable locking of ETN using ASLS
• ETN locked with conventional locking bolts
Conventional surgical procedure

Locations

Country	Name	City	State
Austria	Medizinische Universität	Innsbruck
Germany	Charité	Berlin
Germany	Medizinische Hochschule	Hannover
Germany	Universität des Saarlandes	Homburg/Saar
Germany	Friedrich-Schiller-Universität	Jena
Germany	Universitätsmedizin Mainz	Mainz
Germany	BG Unfallklinik	Tübingen
Norway	Sykehuset i Vestfold HF	Tonsberg

Sponsors (2)

Lead Sponsor	Collaborator
AO Clinical Investigation and Documentation	Synthes Inc.

Countries where clinical trial is conducted

Austria,  Germany,  Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to pain free full weight bearing		1 year	No
Secondary	Amount of partial weight bearing		Up to achievement of primary outcome	No