Dynaloc for Treatment of Femoral Neck Fractures

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Aarhus University Hospital
Sponsor:
Information provided by (Responsible Party):
Lars C. Borris, Aarhus University Hospital
ClinicalTrials.gov Identifier:
NCT02030431
First received: January 7, 2014
Last updated: March 15, 2014
Last verified: March 2014
  Purpose

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


Condition Intervention
Femoral Neck Fracture
Device: Dynaloc
Device: Cancellous screws

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Dynaloc vs. Multiple Cancellous Screws for Treatment of Femoral Neck Fractures

Resource links provided by NLM:


Further study details as provided by Aarhus University Hospital:

Primary Outcome Measures:
  • Shortening of the femoral neck [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Reoperation [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: March 2014
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Cancellous screws
Patients in this group are having osteosynthesis with three screws
Device: Cancellous screws
Active Comparator: Dynaloc
Patients in this group are having osteosynthesis with Dynaloc (three screws fixed in a small plate)
Device: Dynaloc

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02030431

Contacts
Contact: Lars C Borris, MD +4578464513 larsborr@rm.dk

Locations
Denmark
Aarhus University Hospital Recruiting
Aarhus, Denmark, DK-8000
Contact: Lars C Borris, MD    +4578464513    larsborr@rm.dk   
Principal Investigator: Lars C Borris, MD         
Sponsors and Collaborators
Aarhus University Hospital
  More Information

No publications provided

Responsible Party: Lars C. Borris, Consultant of Orthopaedic surgery, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT02030431     History of Changes
Other Study ID Numbers: 1-10-72-362-13
Study First Received: January 7, 2014
Last Updated: March 15, 2014
Health Authority: Denmark: Danish Dataprotection Agency

Additional relevant MeSH terms:
Femoral Neck Fractures
Fractures, Bone
Hip Fractures
Femoral Fractures
Wounds and Injuries
Leg Injuries

ClinicalTrials.gov processed this record on July 29, 2014