Dynaloc for Treatment of Femoral Neck Fractures

Study Overview
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Brief Summary
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A prospective, randomized study comparing the effectiveness of a new system, Dynaloc compared with three cancellous screws, for osteosynthesis of femoral neck fractures

Official Title
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Dynaloc vs. Multiple Cancellous Screws for Treatment of Femoral Neck Fractures

Conditions
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Femoral Neck Fracture

Intervention / Treatment
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* Device: Dynaloc
* Device: Cancellous screws


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 110 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cancellous screws<br>Patients in this group are having osteosynthesis with three screws | Device: Cancellous screws<br> <br> |
| Active Comparator: Dynaloc<br>Patients in this group are having osteosynthesis with Dynaloc (three screws fixed in a small plate) | Device: Dynaloc<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Shortening of the femoral neck |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reoperation |  | 1 year |