Clinical trial NCT00875992: 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
Overall status: COMPLETED
Phase: NA
Conditions: Tibial Fractures
Lead sponsor: AO Innovation Translation Center
Sponsor class: OTHER
Collaborators: name: Synthes Inc.
First posted: 2009-04-06
Enrollment: 141
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Time to pain free full weight bearing
timeFrame: 1 year
Secondary outcomes:
measure: Amount of partial weight bearing
timeFrame: Up to achievement of primary outcome
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Medizinische Universität
city: Berlin
country: Germany
facility: Charité
city: Hannover
country: Germany
facility: Medizinische Hochschule
city: Homburg/Saar
country: Germany
facility: Universität des Saarlandes
city: Jena
country: Germany
facility: Friedrich-Schiller-Universität
city: Mainz
country: Germany
facility: Universitätsmedizin Mainz
city: Tübingen
country: Germany
facility: BG Unfallklinik
city: Tonsberg
country: Norway
facility: Sykehuset i Vestfold HF
Study officials:
affiliation: BG Unfallklinik Tübingen, 72076 Tübingen, Germany
name: Dankward Hoentzsch, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.