Trial to Evaluate the Effectiveness of Angular Stable Locking System (ASLS) in Patients With Distal Tibial Fractures
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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) |
- Time to pain free full weight bearing [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- 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 |
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| 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 | |
| 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 May 16, 2013