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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

141 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2012-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Tibial Fractures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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ETN with ASLS

Angle stable locking of the Expert Tibial Nail using ASLS

Group Type EXPERIMENTAL

ETN with ASLS

Intervention Type DEVICE

Angle stable locking of ETN using ASLS

ETN with conventional locking

Conventional locking of the Expert Tibial Nail using conventional locking bolts

Group Type ACTIVE_COMPARATOR

ETN locked with conventional locking bolts

Intervention Type DEVICE

Conventional surgical procedure

Interventions

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ETN with ASLS

Angle stable locking of ETN using ASLS

Intervention Type DEVICE

ETN locked with conventional locking bolts

Conventional surgical procedure

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No