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

AO Clinical Investigation and Publishing Documentation

Status

Completed

Conditions

Tibial Fractures

Treatments

Device: ETN with ASLS

Device: ETN locked with conventional locking bolts

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00875992

ASLS RCT 09

Details and patient eligibility

About

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.

Full 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.

Enrollment

141 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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