Status:
COMPLETED
Trial to Evaluate the Effectiveness of Angular Stable Locking System (ASLS) in Patients With Distal Tibial Fractures
Lead Sponsor:
AO Clinical Investigation and Publishing Documentation
Collaborating Sponsors:
Synthes Inc.
Conditions:
Tibial Fractures
Eligibility:
All Genders
18+ years
Phase:
NA
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 du...
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 ma...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
141 Patients enrolled
Trial Details
Trial ID
NCT00875992
Start Date
June 1 2009
End Date
December 1 2012
Last Update
January 23 2013
Active Locations (8)
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1
Medizinische Universität
Innsbruck, Austria, 6020
2
Charité
Berlin, Germany, 13353
3
Medizinische Hochschule
Hanover, Germany, 30625
4
Universität des Saarlandes
Homburg/Saar, Germany, 66421