Complications and Functional Outcome of Displaced Femoral Neck Fractures in Patients Younger Than 70 Years

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by University Hospital, Akershus
Sponsor:
Collaborators:
Ullevaal University Hospital
Haukeland University Hospital
Vestre Viken Hospital Trust
Lund University Hospital
Information provided by (Responsible Party):
Stefan Bartels, University Hospital, Akershus
ClinicalTrials.gov Identifier:
NCT02085707
First received: March 9, 2014
Last updated: March 12, 2014
Last verified: March 2014
  Purpose
  1. Introduction
: Patients younger than 70 years with a displaced femoral neck are in serious conditions. The femoral neck fracture (FNF) is associated with low activity levels, hip pain and substantially reduced quality of life (QoL). Relatively young individuals with low-energy fractures tend to have additional morbidity or lower bone quality. The literature indicates that 5 % of all displaced FNFs are in patients aged 55 - 70 years. 3535 patients aged 55 - 70 years were registered in the Norwegian Arthroplasty Registry and in the Norwegian Hip Fracture Registry in the period 2005 - 2012. Little research and lack of consensus and guidance about appropriate treatment of these patients renders choice of treatment and the health economic aspect a great challenge. 
In this study the investigators aim to answer if patients aged 55 - 70 years with displaced and low-energy FNF treated with a total hip arthroplasty (THA) leads to a better functional outcome than osteosynthesis (stabilization by use of hip pins) and can patient-related factors be identified that predispose for FNF?
  2. Background
: Displaced low - energy FNF in patients aged 55 - 70 years is usually treated with osteosynthesis or implantation of a prosthesis. For patients older than 70 years, several randomized studies compare THA with other treatment options; the studies have not found a higher mortality or morbidity for THA. Most orthopedics would probably recommend a closed reposition and osteosynthesis for patients younger than 60 years. Screw fixation procedures will often be of shorter duration and less invasive, but the risk of needing a new operation because of a failure is higher than with prosthetic surgery. With a reoperation the risk of complications is higher than with the first operation. How this affects mortality, morbidity and functional outcome in this patient group is uncertain. Studies have shown both lower morbidity and earlier mortality than with prosthetic surgery. 
On the other hand the reoperation rate because of failed osteosynthesis is 28 - 42% versus about 10% for THA; more recent studies show a reoperation rate for THA of 5%. 
Young patients with low - energy FNF often have other diseases and conditions that may increase the risk of failed osteosynthesis. Reasons may be use of medication (steroids, epilepsy medication), alcoholism or other types of substance abuse and presence of risk factors for osteoporosis. Several review articles and meta - analyses conclude that THA is associated with a lower rate of complications and a better functional outcome than other treatment alternatives.

  3. Goals for the project:

    Map patient - related factors that predispose for displaced FNF for patients aged 55 - 70 years.

    Map bone density measured with Dexa for two types of surgical procedures. Map complications and functional outcome after osteosynthesis (with 2 screws) or THA in patients aged 55 - 70 years with displaced FNF.

  4. Study procedures:
 
It is a randomized multi center study of patients operated with either THA or osteosynthesis (with 2 screws) in which functional outcome, complications and reoperations are compared for the 2 groups. Additional controls are done after 4 and 12 months; 2 and possibly after 3, 5, 10, 15 and 20 years.

Condition Intervention
Displaced Femoral Neck Fractures
Osteoporosis
Procedure: Total hip replacement arthroplasty
Procedure: Closed reduction and internal fixation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: Complications and Functional Outcome of Displaced Femoral Neck Fractures Treated With Internal Fixation vs Total Hip Arthroplasty in Patients Younger Than 70 Years. A Randomized Controlled Double Blind Multi Center Trial.

Resource links provided by NLM:


Further study details as provided by University Hospital, Akershus:

Primary Outcome Measures:
  • Harris Hip score [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Harris Hip Score [ Time Frame: 4 months and 2 years ] [ Designated as safety issue: Yes ]
  • QoL questionnaire (EQ-5D) [ Time Frame: 4 and 12 months, 2 years ] [ Designated as safety issue: No ]
    Measure of health status from the EuroQol

  • Hip dysfunction and Osteoarthritis Outcome Score (HOOS) [ Time Frame: 4 and 12 months, 2 years ] [ Designated as safety issue: No ]
  • VAS [ Time Frame: 4 and 12 months, 2 years ] [ Designated as safety issue: No ]
  • Complications [ Time Frame: 4 and 12 months, 2 years ] [ Designated as safety issue: Yes ]

    Incidence of complications. General complications, f.ex: urinary tract infections, venous thrombosis, pulmonary embolism, pneumonia, mortality.

    Per- and postoperative complications related to method, f.ex: fracture of the femur, bleeding, cut- out, caput necrosis, infection, luxation, periprosthetic fracture, component loosening.


  • Reoperation [ Time Frame: 4 and 12 months, 2 years ] [ Designated as safety issue: No ]
  • Morbidity [ Time Frame: 4 and 12 months, 2 years ] [ Designated as safety issue: Yes ]
  • Mortality [ Time Frame: 4 and 12 months, 2 years ] [ Designated as safety issue: Yes ]
  • Charlson comorbidity index [ Time Frame: 4 and 12 months, 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 118
Study Start Date: December 2013
Estimated Study Completion Date: January 2019
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Total hip replacement arthroplasty
59 off 118 patients will be randomized to total hip replacement arthroplasty
Procedure: Total hip replacement arthroplasty
Active Comparator: Closed reduction and internal fixation

59 off 118 patients will be randomized to closed reduction and internal fixation.

2 cancellous parallel hip pins

Procedure: Closed reduction and internal fixation

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   55 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with displaced femoral neck fractures Garden 3 or 4
  • Age between 55 - 70 years
  • Able to walk before injury

Exclusion Criteria:

  • Refusal to participate.
  • Pathological fractures for other reasons than osteoporosis.
  • Senility or dementia or lack of competence to give informed consent to participate
  • Fracture on the opposite side at the same time
  • Expected life duration less than 12 months and American Society of Anesthesiologists (ASA) 4 + 5
  • Amputated leg
  • Serious neurological disease that renders THA unsuitable
  • Substance narcotic abuse
  • Previous inclusion in the present study

  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: NCT02085707

Contacts
Contact: Stefan Bartels, MD 91502900 ext 0047 stba@ahus.no
Contact: Stein Erik Utvåg, PhD 91502900 ext 0047 stein.erik.utvag@medisin.uio.no

Locations
Norway
Vestre Viken HF Not yet recruiting
Bærum, Akershus, Norway, 1346
Contact: Wender Figved, PhD    91503525 ext 0047      
Principal Investigator: Wender Figved, PhD         
University Hospital, Akershus Recruiting
Lørenskog, Akershus, Norway, 1478
Contact: Stefan Bartels, MD    91502900 ext 0047    stba@ahus.no   
Haukeland University Hospital Not yet recruiting
Bergen, Hordaland, Norway, 5021
Contact: Jan- Erik Gjertsen, PhD    55985000 ext 0047      
Principal Investigator: Jan-Erik Gjertsen, PhD         
Ullevaal University Hospital Not yet recruiting
Oslo, Norway, 0450
Contact: Frede Frihagen, PhD    22118080 ext 0047      
Principal Investigator: Frede Frihagen, PhD         
Sponsors and Collaborators
University Hospital, Akershus
Ullevaal University Hospital
Haukeland University Hospital
Vestre Viken Hospital Trust
Lund University Hospital
Investigators
Principal Investigator: Torbjørn Omland, Professor University Hospital, Akershus
  More Information

Publications:

Responsible Party: Stefan Bartels, MD Senior Consultant, University Hospital, Akershus
ClinicalTrials.gov Identifier: NCT02085707     History of Changes
Other Study ID Numbers: Akershus UH, Sophies Minde Ortopedi AS
Study First Received: March 9, 2014
Last Updated: March 12, 2014
Health Authority: Norway:National Committee for Medical and Health Research Ethics
Norway: Ministry of Health and Care Services

Additional relevant MeSH terms:
Femoral Neck Fractures
Fractures, Bone
Osteoporosis
Hip Fractures
Femoral Fractures
Wounds and Injuries
Leg Injuries
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on July 20, 2014