Evaluation of Handling and Possible Complications Related to the Newly Developed Angular Stable Locking System (ASLS)

NCT ID: NCT00793637

Last Updated: 2021-07-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2009-08-31

Brief Summary

In many cases, the existing locking bolts and screws in intramedullary nails do not provide sufficient stability. Due to the play between screw and nail, the reduction can be lost and the instability can result in malunions, nonunions, or pseudoarthrosis. Consequently, secondary angular fracture dislocation (defined as a difference of the angle of 10° or more from the post-operative to the follow-up x-rays) can be observed in approximately 30% of patients after conventional intramedullary nailing of proximal third tibial fractures and in approximately 0-2% in patients with distal third tibial fractures. Therefore, an Angular Stable Locking System for Intramedullary Nails (ASLS) was developed to reduce the risk of secondary loss of reduction by providing axial and angular stability. ASLS provides angular stable fixation between nails and screws with resorbable sleeves used as dowels in the nail locking holes.

The present study evaluates the handling of ASLS and the surgeon's compliance as well as any complications occurring during the baseline and the follow-up period in patients with proximal and distal tibial, femoral and humeral fractures treated with intramedullary nails. Furthermore, the relationship of any occurred complications to ASLS will be assessed.

Conditions

Humerus Fracture; Femur Fracture; Tibia Fracture

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Surgical

Patients with proximal and/or distal tibial, femoral and/or humeral fractures treated with intramedullary nails and the Angular Stable Locking System(ASLS)

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• The patient is ≥ 18 years old
• One of the following bones is fractured so that the fracture is affecting the proximal or the distal third of the bone without affecting the joint surface: Humerus, Femur, Tibia
• The fracture is fixed with one of the following cannulated implants Humerus: Expert HN, Expert PHN. Femur: Expert LFN, Expert RAFN, CFN, DFN, AFN. Tibia: Expert TN, CTN.
• The patient is willing and able to participate in the study follow-up according to the CIP.
• 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.

Exclusion Criteria

• The patient is legally incompetent.
• Preexistent malunion or nonunion of the bone that is planned to be treated with ASLS.
• The patient suffers from a polytrauma (multiple injuries, whereof one or the combination of several injuries is life-threatening).
• The patient suffers from active malignancy.
• The patient is affected by drug or alcohol abuse.
• The patient has participated in any other device or drug related clinical trial within the previous month.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Synthes Inc.

INDUSTRY

Sponsor Role: collaborator

AO Clinical Investigation and Publishing Documentation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dankward Hoentzsch, MD

Role: PRINCIPAL_INVESTIGATOR

BG Unfallklinik Tübingen, 72076 Tübingen, Germany

Locations

Medizinische Universität Innsbruck, Abteilung Unfallchirurgie und Sporttraumatologie

Innsbruck, , Austria

Charité - Universitätsmedizin Berlin, Centrum für Muskuloskeletale Chirurgie

Berlin, , Germany

Universitätsklinikum Mainz, Klinik und Poliklinik für Unfallchirurgie

Mainz, , Germany

BG Unfallklinik Tübingen

Tübingen, , Germany

Countries

Austria; Germany

Other Identifiers

ASLS-Pre-08

Identifier Type: -

Identifier Source: org_study_id