Dynaloc for Treatment of Femoral Neck Fractures

Femoral Neck Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02030431
• Other study ID #: 1-10-72-362-13
• Status: Terminated
• Phase: N/A
• First received: January 7, 2014
• Last updated: October 19, 2015
• Start date: March 2014
• Est. completion date: October 2015

Study information

• Verified date: October 2015
• Source: Aarhus University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 150
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 110 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Femoral Neck Fracture
• Femoral Neck Fractures
• Fractures, Bone

Intervention

Device:
• Dynaloc

• Cancellous screws

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Shortening of the femoral neck		1 year	No
Secondary	Reoperation		1 year	No