Femoral Neck FractureNCT02030431
Dynaloc for Treatment of Femoral Neck Fractures
A study testing Dynaloc and Cancellous screws in people with Femoral Neck Fracture, run by Aarhus University Hospital at 1 site in Denmark.
Trial summary
A prospective, randomized study comparing the effectiveness of a new system, Dynaloc compared with three cancellous screws, for osteosynthesis of femoral neck fractures Read more about this study
- Who is it for?
- Ages 50 to 110 years
- Conditions the study is for
- Femoral Neck Fracture
- What is being tested?
- Dynaloc and Cancellous screws
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2014to Oct 2015
- 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 50 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult men or women (see age specifications below) with subcapital femoral neck fractures (stable or unstable) confirmed with anteroposterior and lateral hip radiographs, computed tomography, or magnetic resonance imaging (MRI).
- Patients between 50 and 69 years of age with any Garden type femoral neck fracture
- Patients older than 70 years of age with femoral neck fractures Garden type I and II
- Patients older than 70 years of age with a femoral neck fracture Garden types III and IV and contraindication to hemiarthroplasty.
- Operative treatment within 4 days (i.e., 72 hours) of presenting to the emergency room.
- Patient was ambulatory prior to fracture, though they may have used an aid such as a cane or a walker.
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- Anticipated medical optimalization of the patient for operative fixation of the hip.
- Provision of informed consent by patient or proxy.
- Low energy fracture (defined as a fall from standing height).
- No other major trauma.
Who cannot join
- Associated major injuries of the lower extremity (i.e., ipsilateral or contralateral fractures of the foot, ankle, tibia, fibula, knee, or femur; dislocations of the ankle, knee, or hip; or femoral head defects or fracture).
- Retained hardware around the affected hip.
- Abnormal opposite hip making end-point evaluation impossible
- Infection around the hip (i.e., soft tissue or bone).
- Patients with disorders of bone metabolism other than osteoporosis (i.e., Paget's disease, renal osteodystrophy).
- Moderate or severe cognitively impaired patients (i.e., Six Item Screener with three or more errors).
- Patients with Parkinson's disease (or dementia or other neurological deficit) severe enough to increase the likelihood of falling or severe enough to compromise rehabilitation.
- Likely problems, in the judgment of the investigators, with maintaining follow-up. We will, for example, exclude patients with no fixed address, those who report a plan to move out of town in the next year, or intellectually challenged patients without adequate family support.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dynaloc vs. Multiple Cancellous Screws for Treatment of Femoral Neck Fractures
A prospective, randomized study comparing the effectiveness of a new system, Dynaloc compared with three cancellous screws, for osteosynthesis of femoral neck fractures
- Conditions
- Femoral Neck Fracture
- Being tested
- Dynaloc, Cancellous screws
- Medical subject headings
- Femoral Neck Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DynalocDevice
Cancellous screwsDevice
| Study group | Role | What they receive |
|---|---|---|
| Cancellous screws | Active comparator | Patients in this group are having osteosynthesis with three screws Receives: Device: Cancellous screws |
| Dynaloc | Active comparator | Patients in this group are having osteosynthesis with Dynaloc (three screws fixed in a small plate) Receives: Device: Dynaloc |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shortening of the femoral neck
Measured: 1 year
Secondary outcomes (1)
Reoperation
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2014 (estimated)
- Study startMar 2014
- Primary completionOct 2015
- Study completionOct 2015
Why it stopped: overweight of hard-ware removals in the Dynaloc group
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femoral Neck FractureStudies of the same condition, open and under way.
- More trials run by Aarhus University HospitalThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lars C. Borris, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02030431
- Sponsor's protocol ID
- 1-10-72-362-13
- Status last verified
- Oct 2015
- First submitted
- 7 Jan 2014
- Last updated
- 20 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynaloc vs. Multiple Cancellous Screws for Treatment of Femoral Neck Fractures
- ClinicalTrials.gov ID
- NCT02030431
- Acronym / sponsor ID
- 1-10-72-362-13
- Conditions
- Femoral Neck Fracture
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: overweight of hard-ware removals in the Dynaloc group
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 8 Jan 2014 (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.
A prospective, randomized study comparing the effectiveness of a new system, Dynaloc compared with three cancellous screws, for osteosynthesis of femoral neck fractures
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cancellous screws | Active comparator | Device: Cancellous screwsPatients in this group are having osteosynthesis with three screws |
| Dynaloc | Active comparator | Device: DynalocPatients in this group are having osteosynthesis with Dynaloc (three screws fixed in a small plate) |
Who may qualify
- Ages
- 50 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Adult men or women (see age specifications below) with subcapital femoral neck fractures (stable or unstable) confirmed with anteroposterior and lateral hip radiographs, computed tomography, or magnetic resonance imaging (MRI).
- Patients between 50 and 69 years of age with any Garden type femoral neck fracture
- Patients older than 70 years of age with femoral neck fractures Garden type I and II
- Patients older than 70 years of age with a femoral neck fracture Garden types III and IV and contraindication to hemiarthroplasty.
- Operative treatment within 4 days (i.e., 72 hours) of presenting to the emergency room.
Key exclusion criteria (8 listed)
- Associated major injuries of the lower extremity (i.e., ipsilateral or contralateral fractures of the foot, ankle, tibia, fibula, knee, or femur; dislocations of the ankle, knee, or hip; or femoral head defects or fracture).
- Retained hardware around the affected hip.
- Abnormal opposite hip making end-point evaluation impossible
- Infection around the hip (i.e., soft tissue or bone).
- Patients with disorders of bone metabolism other than osteoporosis (i.e., Paget's disease, renal osteodystrophy).
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 |
|---|---|---|
| Dynaloc | Device | Dynaloc |
| Cancellous screws | Device | Cancellous screws |
Primary outcome
Shortening of the femoral neck
Time frame: 1 year
1 secondary outcome
Reoperation
Time frame: 1 year
Results and safety
The study was stopped early (reason given: overweight of hard-ware removals in the Dynaloc group). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dynaloc and Cancellous screws in people with Femoral Neck Fracture, run by Aarhus University Hospital at 1 site in Denmark.
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 10 inclusion and 8 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: stopped early, as of the sponsor's last update on 20 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. 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 was stopped early (reason given: overweight of hard-ware removals in the Dynaloc group). Results are not available in the source record.
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?
Shortening of the femoral neck (time frame: 1 year). 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 20 Oct 2015.