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

Primary Purpose

Tibial Fractures

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
ETN with ASLS
ETN locked with conventional locking bolts
Sponsored by
AO Clinical Investigation and Publishing Documentation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tibial Fractures

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Medizinische Universität
  • Charité
  • Medizinische Hochschule
  • Universität des Saarlandes
  • Friedrich-Schiller-Universität
  • Universitätsmedizin Mainz
  • BG Unfallklinik
  • Sykehuset i Vestfold HF

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ETN with ASLS

ETN with conventional locking

Arm Description

Angle stable locking of the Expert Tibial Nail using ASLS

Conventional locking of the Expert Tibial Nail using conventional locking bolts

Outcomes

Primary Outcome Measures

Time to pain free full weight bearing

Secondary Outcome Measures

Amount of partial weight bearing

Full Information

First Posted
April 3, 2009
Last Updated
January 22, 2013
Sponsor
AO Clinical Investigation and Publishing Documentation
Collaborators
Synthes Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00875992
Brief Title
Trial to Evaluate the Effectiveness of Angular Stable Locking System (ASLS) in Patients With Distal Tibial Fractures
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)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AO Clinical Investigation and Publishing Documentation
Collaborators
Synthes Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tibial Fractures

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
141 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ETN with ASLS
Arm Type
Experimental
Arm Description
Angle stable locking of the Expert Tibial Nail using ASLS
Arm Title
ETN with conventional locking
Arm Type
Active Comparator
Arm Description
Conventional locking of the Expert Tibial Nail using conventional locking bolts
Intervention Type
Device
Intervention Name(s)
ETN with ASLS
Intervention Description
Angle stable locking of ETN using ASLS
Intervention Type
Device
Intervention Name(s)
ETN locked with conventional locking bolts
Intervention Description
Conventional surgical procedure
Primary Outcome Measure Information:
Title
Time to pain free full weight bearing
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Amount of partial weight bearing
Time Frame
Up to achievement of primary outcome

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dankward Hoentzsch, MD
Organizational Affiliation
BG Unfallklinik Tübingen, 72076 Tübingen, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medizinische Universität
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
Facility Name
Charité
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Medizinische Hochschule
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Universität des Saarlandes
City
Homburg/Saar
ZIP/Postal Code
66421
Country
Germany
Facility Name
Friedrich-Schiller-Universität
City
Jena
ZIP/Postal Code
07740
Country
Germany
Facility Name
Universitätsmedizin Mainz
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
BG Unfallklinik
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Sykehuset i Vestfold HF
City
Tonsberg
ZIP/Postal Code
3103
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
25410507
Citation
Hontzsch D, Schaser KD, Hofmann GO, Pohlemann T, Hem ES, Rothenbach E, Krettek C, Attal R. Evaluation of the effectiveness of the angular stable locking system in patients with distal tibial fractures treated with intramedullary nailing: a multicenter randomized controlled trial. J Bone Joint Surg Am. 2014 Nov 19;96(22):1889-97. doi: 10.2106/JBJS.M.01355.
Results Reference
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Trial to Evaluate the Effectiveness of Angular Stable Locking System (ASLS) in Patients With Distal Tibial Fractures

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