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NCT Number: NCT00793637

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

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.

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Key information

Conditions

Humerus Fracture Arm Injuries Femoral Fractures Femur Fracture Fractures, Bone Humeral Fractures Leg Injuries Tibia Fracture Tibial Fractures Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medizinische Universität Innsbruck, Abteilung Unfallchirurgie und Sporttraumatologie, Innsbruck, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Surgeon's compliance and handling-oriented questionnaire

    Time frame: During surgery

Secondary outcomes

  1. Rate of Complications

    Time frame: 6 months

  2. General pain and pain at fracture site assessed by VAS

    Time frame: 6 months

  3. Walking ability in patients with femoral or tibial fractures using the Parker mobility score

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

AO Clinical Investigation and Publishing Documentation

Other

Collaborators

  • Synthes Inc.

Registry information

Official study title

Prospective Multicenter Case Series to Evaluate Handling and Possible Complications Related to the Angular Stable Locking System in Patients With Proximal and Distal Tibial, Femoral and Humeral Fractures Treated With Intramedullary Nails

Acronym: ASLS-Pre

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Nov 19, 2008
Registry last updated
Jul 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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