Dynaloc for Treatment of Femoral Neck Fractures

NCT02030431 | Terminated DMC

• 1 other identifier: 1-10-72-362-13
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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

Conditions

Femoral Neck Fracture

Outcome Measures

Primary Outcomes (1)

• Shortening of the femoral neck

  1 year

Secondary Outcomes (1)

• Reoperation

  1 year

Study Arms (2)

Cancellous screws

ACTIVE COMPARATOR

Patients in this group are having osteosynthesis with three screws

Device: Cancellous screws

Dynaloc

ACTIVE COMPARATOR

Patients in this group are having osteosynthesis with Dynaloc (three screws fixed in a small plate)

Device: Dynaloc

Interventions

Dynaloc DEVICE

Dynaloc

Cancellous screws DEVICE

Cancellous screws

Eligibility Criteria

• Age: 50 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aarhus University Hospital: lead

Study Sites (1)

Aarhus University Hospital

Aarhus, DK-8000, Denmark

Location

MeSH Terms

Conditions

Femoral Neck Fractures

Condition Hierarchy (Ancestors)

Hip Fractures; Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant of Orthopaedic surgery

Study Record Dates

• First Submitted: January 7, 2014
• First Posted: January 8, 2014
• Study Start: March 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: October 20, 2015

Record last verified: 2015-10

Locations

DK (1)