Dynaloc for Treatment of Femoral Neck Fractures
Primary Purpose
Femoral Neck Fracture
Status
Terminated
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Dynaloc
Cancellous screws
Sponsored by
About this trial
This is an interventional treatment trial for Femoral Neck Fracture
Eligibility Criteria
Inclusion Criteria:
- 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.
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Aarhus University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Cancellous screws
Dynaloc
Arm Description
Patients in this group are having osteosynthesis with three screws
Patients in this group are having osteosynthesis with Dynaloc (three screws fixed in a small plate)
Outcomes
Primary Outcome Measures
Shortening of the femoral neck
Secondary Outcome Measures
Reoperation
Full Information
NCT ID
NCT02030431
First Posted
January 7, 2014
Last Updated
October 19, 2015
Sponsor
Aarhus University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02030431
Brief Title
Dynaloc for Treatment of Femoral Neck Fractures
Official Title
Dynaloc vs. Multiple Cancellous Screws for Treatment of Femoral Neck Fractures
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Terminated
Why Stopped
overweight of hard-ware removals in the Dynaloc group
Study Start Date
March 2014 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aarhus University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
A prospective, randomized study comparing the effectiveness of a new system, Dynaloc compared with three cancellous screws, for osteosynthesis of femoral neck fractures
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Femoral Neck Fracture
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cancellous screws
Arm Type
Active Comparator
Arm Description
Patients in this group are having osteosynthesis with three screws
Arm Title
Dynaloc
Arm Type
Active Comparator
Arm Description
Patients in this group are having osteosynthesis with Dynaloc (three screws fixed in a small plate)
Intervention Type
Device
Intervention Name(s)
Dynaloc
Intervention Type
Device
Intervention Name(s)
Cancellous screws
Primary Outcome Measure Information:
Title
Shortening of the femoral neck
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Reoperation
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
110 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
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.
Exclusion Criteria:
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.
Facility Information:
Facility Name
Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
DK-8000
Country
Denmark
12. IPD Sharing Statement
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Dynaloc for Treatment of Femoral Neck Fractures
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