Dynaloc for Treatment of Femoral Neck Fractures

Not Applicable

Terminated

• Conditions: Femoral Neck Fracture

• Registration Number: NCT02030431
• Lead Sponsor: Aarhus University Hospital

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-01-07
• Study First Submitted QC: 2014-01-07
• Study First Posted: 2014-01-08
• Study Start: 2014-03
• Status Verified: 2015-10
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Last Update Submitted: 2015-10-19
• Last Update Posted: 2015-10-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 150

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Shortening of the femoral neck	1 year

Secondary Outcome Measures

Name	Time	Method
Reoperation	1 year

Trial Locations

Locations (1)

Aarhus University Hospital; 🇩🇰 Aarhus, Denmark