Tibial FracturesNCT00875992
Trial to Evaluate the Effectiveness of Angular Stable Locking System (ASLS) in Patients With Distal Tibial Fractures
A study testing ETN with ASLS and ETN locked with conventional locking bolts in people with Tibial Fractures, run by AO Clinical Investigation and Publishing Documentation at 8 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tibial Fractures
- What is being tested?
- ETN with ASLS and ETN locked with conventional locking bolts
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 141 participants
- Where
- 8 sitesin 3 countries
- Study dates
- Jun 2009to Dec 2012
- Phase
- Interventional
- 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
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
8 sites in 3 countries.
8 sites in 3 countries
Germany6 sites
Charité
Berlin, 13353
Medizinische Hochschule
Hanover, 30625
Universität des Saarlandes
Homburg/Saar, 66421
Friedrich-Schiller-Universität
Jena, 07740
Universitätsmedizin Mainz
Mainz, 55131
BG Unfallklinik
Tübingen, 72076
About this study
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)
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.
Read the 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.
- Conditions
- Tibial Fractures
- Being tested
- ETN with ASLS, ETN locked with conventional locking bolts
- Medical subject headings
- Tibial Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ETN with ASLSDevice
Angle stable locking of ETN using ASLS
ETN locked with conventional locking boltsDevice
Conventional surgical procedure
| Study group | Role | What they receive |
|---|---|---|
| ETN with ASLS | Experimental | Angle stable locking of the Expert Tibial Nail using ASLS Receives: Device: ETN with ASLS |
| ETN with conventional locking | Active comparator | Conventional locking of the Expert Tibial Nail using conventional locking bolts Receives: Device: ETN locked with conventional locking bolts |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to pain free full weight bearing
Measured: 1 year
Secondary outcomes (1)
Amount of partial weight bearing
Measured: Up to achievement of primary outcome
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2009 (estimated)
- Study startJun 2009
- Primary completionAug 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tibial FracturesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 141 participants (actual)
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
- NCT00875992
- Sponsor's protocol ID
- ASLS RCT 09
- Status last verified
- Jan 2013
- First submitted
- 3 Apr 2009
- Last updated
- 23 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25410507
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00875992
- Acronym / sponsor ID
- ASLS RCT 09
- Conditions
- Tibial Fractures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- AO Clinical Investigation and Publishing DocumentationUniversity, hospital or other
- Collaborators
- Synthes Inc.
- Study start
- Jun 2009
- Primary completion
- Aug 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 6 Apr 2009 (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. 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ETN with ASLS | Experimental | Device: ETN with ASLSAngle stable locking of the Expert Tibial Nail using ASLS |
| ETN with conventional locking | Active comparator | Device: ETN locked with conventional locking boltsConventional locking of the Expert Tibial Nail using conventional locking bolts |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ETN with ASLSAngle stable locking of ETN using ASLS | Device | ETN with ASLS |
| ETN locked with conventional locking boltsConventional surgical procedure | Device | ETN with conventional locking |
Primary outcome
Time to pain free full weight bearing
Time frame: 1 year
1 secondary outcome
Amount of partial weight bearing
Time frame: Up to achievement of primary outcome
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 23 Jan 2013.
- Derived from this study: PubMed 25410507Hontzsch 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.
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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
8 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ETN with ASLS and ETN locked with conventional locking bolts in people with Tibial Fractures, run by AO Clinical Investigation and Publishing Documentation at 8 sites in 3 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 7 inclusion and 11 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 23 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Germany, Austria, Norway. 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?
Time to pain free full weight bearing (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00875992, which also lists 1 linked publication.
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 23 Jan 2013.