Trials / Completed
CompletedNCT00875992
Trial to Evaluate the Effectiveness of Angular Stable Locking System (ASLS) in Patients With Distal Tibial Fractures
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)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 141 (actual)
- Sponsor
- AO Clinical Investigation and Publishing Documentation · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | ETN with ASLS | Angle stable locking of ETN using ASLS |
| DEVICE | ETN locked with conventional locking bolts | Conventional surgical procedure |
Timeline
- Start date
- 2009-06-01
- Primary completion
- 2012-08-01
- Completion
- 2012-12-01
- First posted
- 2009-04-06
- Last updated
- 2013-01-23
Locations
8 sites across 3 countries: Austria, Germany, Norway
Source: ClinicalTrials.gov record NCT00875992. Inclusion in this directory is not an endorsement.