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

This study has been completed.
Sponsor:
Collaborator:
Synthes Inc.
Information provided by (Responsible Party):
AO Clinical Investigation and Documentation
ClinicalTrials.gov Identifier:
NCT00875992
First received: April 3, 2009
Last updated: January 22, 2013
Last verified: January 2013
  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: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
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:


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 ]

Enrollment: 141
Study Start Date: June 2009
Study Completion Date: December 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ETN with ASLS
Angle stable locking of the Expert Tibial Nail using ASLS
Device: ETN with ASLS
Angle stable locking of ETN using ASLS
Active Comparator: ETN with conventional locking
Conventional locking of the Expert Tibial Nail using conventional locking bolts
Device: ETN locked with conventional locking bolts
Conventional surgical procedure

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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Austria
Medizinische Universität
Innsbruck, Austria, 6020
Germany
Charité
Berlin, Germany, 13353
Medizinische Hochschule
Hannover, Germany, 30625
Universität des Saarlandes
Homburg/Saar, Germany, 66421
Friedrich-Schiller-Universität
Jena, Germany, 07740
Universitätsmedizin Mainz
Mainz, Germany, 55131
BG Unfallklinik
Tübingen, Germany, 72076
Norway
Sykehuset i Vestfold HF
Tonsberg, Norway, 3103
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: AO Clinical Investigation and Documentation
ClinicalTrials.gov Identifier: NCT00875992     History of Changes
Other Study ID Numbers: ASLS RCT 09
Study First Received: April 3, 2009
Last Updated: January 22, 2013
Health Authority: Germany: Ethics Commission
Austria: Ethikkommission
Norway: Ethics Committee

Additional relevant MeSH terms:
Fractures, Bone
Tibial Fractures
Wounds and Injuries
Leg Injuries

ClinicalTrials.gov processed this record on September 18, 2014