Humerus FractureASLS-PreNCT00793637
Evaluation of Handling and Possible Complications Related to the Newly Developed Angular Stable Locking System (ASLS)
An observational study of Humerus Fracture and Femur Fracture, run by AO Clinical Investigation and Publishing Documentation at 4 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Humerus Fracture, Femur Fracture, Tibia Fracture
- How many people
- 30 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Aug 2008to Aug 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: orthopedic clinics
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Germany3 sites
Charité - Universitätsmedizin Berlin, Centrum für Muskuloskeletale Chirurgie
Berlin, 13353
Universitätsklinikum Mainz, Klinik und Poliklinik für Unfallchirurgie
Mainz, 55131
BG Unfallklinik Tübingen
Tübingen, 72076
Austria1 site
Medizinische Universität Innsbruck, Abteilung Unfallchirurgie und Sporttraumatologie
Innsbruck, 6020
About this study
Official 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
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
- Keywords
- Angular stable locking system, Handling test, Complications
- Medical subject headings
- Humeral Fractures, Femoral Fractures, Tibial Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Surgical | Patients with proximal and/or distal tibial, femoral and/or humeral fractures treated with intramedullary nails and the Angular Stable Locking System(ASLS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgeon's compliance and handling-oriented questionnaire
Measured: During surgery
Secondary outcomes (3)
Rate of Complications
Measured: 6 months
General pain and pain at fracture site assessed by VAS
Measured: 6 months
Walking ability in patients with femoral or tibial fractures using the Parker mobility score
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2008 (estimated)
- Study startAug 2008
- Primary completionJul 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Humerus FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AO Clinical Investigation and Publishing Documentation
- Sponsor type
- University, hospital or other
- Collaborators
- Synthes Inc.
- Responsible party
- Sponsor
- Investigators
- Dankward Hoentzsch, MD, Principal investigator, BG Unfallklinik Tübingen, 72076 Tübingen, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00793637
- Sponsor's protocol ID
- ASLS-Pre-08
- Acronym
- ASLS-Pre
- Status last verified
- Aug 2009
- First submitted
- 17 Nov 2008
- Last updated
- 22 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT00793637
- Acronym / sponsor ID
- ASLS-Pre / ASLS-Pre-08
- Conditions
- Humerus Fracture, Femur Fracture, Tibia Fracture
- Keywords
- Angular stable locking system, Handling test, Complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- AO Clinical Investigation and Publishing DocumentationUniversity, hospital or other
- Collaborators
- Synthes Inc.
- Study start
- Aug 2008
- Primary completion
- Jul 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 19 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgical | – | –Patients with proximal and/or distal tibial, femoral and/or humeral fractures treated with intramedullary nails and the Angular Stable Locking System(ASLS) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- orthopedic clinics
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Surgeon's compliance and handling-oriented questionnaire
Time frame: During surgery
3 secondary outcomes
Rate of Complications
Time frame: 6 months
General pain and pain at fracture site assessed by VAS
Time frame: 6 months
Walking ability in patients with femoral or tibial fractures using the Parker mobility score
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dankward Hoentzsch, MD principal investigator
BG Unfallklinik Tübingen, 72076 Tübingen, Germany
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Humerus Fracture and Femur Fracture, run by AO Clinical Investigation and Publishing Documentation at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgeon's compliance and handling-oriented questionnaire (time frame: During surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2021.