Undisplaced Femoral Neck Fractures in the Elderly: A Trial Comparing Internal Fixation to Hemiarthroplasty

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by University Hospital, Akershus
Sponsor:
Collaborators:
University of Oslo, Faculty of Medicine
Asker & Baerum Hospital
Sykehuset Innlandet HF
Vestre Viken Hospital Trust
Sophies Minde Ortopedi AS
Information provided by (Responsible Party):
Filip C Dolatowski, University Hospital, Akershus
ClinicalTrials.gov Identifier:
NCT01770769
First received: April 25, 2012
Last updated: January 17, 2013
Last verified: January 2013
  Purpose

Clinical research during the last ten years has revealed that elderly patients with a displaced femoral neck fracture should be treated with arthroplasty instead of closed reduction of the fracture followed by internal fixation with pins or screws. Few clinical trials have addressed undisplaced or minimally displaced fractures of the femoral neck. These fractures have been associated with a good prognosis and likewise a good functional outcome. However, recent articles present far less favorable results, with high re-operation rates (10-15%), reduced function, and pain on walking after internal fixation. Indirect comparing studies, suggest that hemiarthroplasty may yield better functional outcomes and lower re-operation rates. Approximately 20% of all femoral neck fractures in patients aged 70 years or older are minimally displaced or undisplaced. Hence the investigators call for a randomised controlled trial comparing pain, function, walking ability, quality of life, re-operation rates and complications after internal fixation versus hemiarthroplasty in patients aged 70 years and older.


Condition Intervention
Femoral Neck Fractures
Device: Hemi - arthroplasty
Device: internal fixation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Undisplaced Femoral Neck Fractures in Patients Aged 70 Years and Older: A Randomised Controlled Trial Comparing Internal Fixation to Hemiarthroplasty

Resource links provided by NLM:


Further study details as provided by University Hospital, Akershus:

Primary Outcome Measures:
  • Change in Harris Hip Score of 10 points or more. [ Time Frame: Baseline prior to fracture, 3 months, 1 year and 2 years ] [ Designated as safety issue: No ]
    Harris hip score - a validated outcome measure to evaluate hip fracture intervention The physiotherapist recording the Harris Hips Score after 3 months, 1 year and two years is blinded. Clinical examination of the hip is carried out with masking of proximal thigh by proper clothes.


Secondary Outcome Measures:
  • Euro-Quol 5 dimension (Eq5d) [ Time Frame: Baseline prior to fracture, 3 months, 1 year and 2 years ] [ Designated as safety issue: No ]
    Eq5D a validated measure of quality of life and to be utilised in health economic models comparing hospital and society costs of the two surgical methods compared. The investigator is blinded.

  • Numeric pain intensity scale (0-10) [ Time Frame: Two weeks prior to fracture (retrospective), at discharge at an average 3-5 days after surgery, after 3 months, 1 year and 2 years ] [ Designated as safety issue: No ]
    Visual analog scale variant with numbers from ranging from zero (no pain) to ten (worst possible pain). The investigator is blinded.

  • Timed Up and Go test (TUG test) [ Time Frame: 3 months, 1 year and 2 years ] [ Designated as safety issue: No ]
    Patient sits on a chair, rises, walks 3 meters passing a mark, turns around, walks back and sits down. The time is recorded in seconds. The investigator is blinded.

  • Reoperation rate [ Time Frame: 5 years after surgery ] [ Designated as safety issue: No ]
    All complications are continually recorded in both trial arms.

  • Death [ Time Frame: 5 years after surgery ] [ Designated as safety issue: No ]
    All deaths are recorded

  • Mini mental state(MMSE-NR) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Mini mental state is recorded only at 3 months follow-up

  • Hospital and society costs [ Time Frame: at baseline prior to fracture, at discharge, 3 months, 1 year and 2 years ] [ Designated as safety issue: No ]
    Use of governmental and private health care services and assistance by family members and relatives are all recorded. Validated health economical models are used to calculate the costs.


Estimated Enrollment: 190
Study Start Date: February 2012
Estimated Study Completion Date: February 2017
Estimated Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Internal fixation - standard treatment
Internal fixation with two parallel cancellous screws (Hip Pins(R)) Current standard treatment
Device: internal fixation
Two cancellous parallel screws - internal fixation of the femoral neck fracture
Other Names:
  • Hip Pins (R)
  • Cloxacillin perioperative prophylaxis
  • Fragmin (Dalteparin) anticoagulation for 2 wks
Experimental: Hemi - arthroplasty
cemented Hemi - arthroplasty (Exeter(R)) modular system V40 by Stryker. Refobacin cement.
Device: Hemi - arthroplasty
cemented hemi - arthroplasty
Other Names:
  • Hemi - arthroplasty by Stryker - Exeter V40(R)
  • Refobacin® Bone Cement R & Biomet
  • Cloxacillin perioperative prophylaxis
  • Fragmin (Dalteparin) anticoagulation for 2 wks

Detailed Description:

The consequences of a femoral neck fracture still have a substantial impact on the individual patient´s health as well as on society. Approximately 5000 individuals suffer a fracture of the femoral neck annually in Norway. The mortality rate approximates 25% during the first year after this injury. The hospital costs of treating a single femoral neck fracture, have been estimated to 20 000 euros.

In spite of relatively well-documented treatment protocols, there is still a need for prospective randomised controlled trials to determine the optimal treatment of certain sub-groups of patients presenting with a femoral neck fracture.

Several studies with a high level of evidence have elucidated management of displaced femoral neck fractures. There is increasing evidence favouring joint replacement surgery over internal fixation when treating displaced femoral neck fractures. However, management of undisplaced and minimally displaced femoral neck fractures has received less attention.

According to the Cochrane Library, there are no randomised controlled trials comparing internal fixation to hemiarthroplasty in patients with undisplaced femoral neck fractures. Previous studies have focused mostly on fracture healing, equating fracture union and success. However, recent studies report decreased functional and life quality scores amongst patients with undisplaced femoral neck fractures treated with internal fixation. The control group in these studies consists of patients with a displaced femoral neck fracture treated with hemi - arthroplasty. Zlowodzki et al showed, by means of validated assessment scores, that patients with internally fixated undisplaced femoral neck fractures often experience shortening of the injured limb. Then again, this is associated with lower functional and life quality scores. In Rogmark´s series of patients with undisplaced femoral neck fractures treated with internal fixation, 25% patients report daily pain from the affected hip upon walking, one and a half year after surgery. Gjertsen et al analysed data for the Norwegian hip fracture registry from more than 4000 patients to demonstrate that treatment with hemiarthroplasty, due to a displaced femoral neck fracture, is associated with better function and less pain than treatment with internal fixation due to an undisplaced femoral neck fracture.

Thus, our research group will conduct a prospective randomised controlled trial to identify any differences in clinical outcome after surgical treatment of undisplaced femoral neck fractures in patients aged 70 years and older. The two methods that will be compared are internal fixation with two screws and modern modular hemiarthroplasty. The primary outcome measure is a difference of at least 10 points in Harris Hip Score (95% power, standard deviation approximates 15 points from previous Norwegian patient series). The primary follow-up length is set to two years, but a long-term follow-up five years after surgery is also planned. It is important to include the cognitively impaired patients as they account for 20-25% of the study population. Patients who cannot provide informed consent due to impaired cognitive function, are included if consent is provided by a family member or relative.

  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 70 years or older
  • Undisplaced or minimally displaced medial femoral neck fracture (Garden I or II)
  • Patient able to walk before injury (all aids allowed)
  • Patient lives within the catchment area of Akershus University Hospital

Exclusion Criteria:

  • Pathologic fracture
  • Current soft tissue or deep infection in the hip or pelvis area
  • ASA IV patients as classified by the anesthesiologist
  • Other contraindications to either of the two methods compared
  • Temporarily impaired cognitive function:

(That is when the patient is judged as unable to provide an informed consent by the surgeon on call and there is no previous history of impaired cognitive function as documented by previous hospital record or a family member / proxy)

  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: NCT01770769

Contacts
Contact: Filip C Dolatowski, MD +4791502900 fido@ahus.no
Contact: Stein Erik Utvåg, PhD +4791502900 stein.erik.utvag@medisin.uio.no

Locations
Norway
Akershus University Hospital Recruiting
Lørenskog, Norway, N-1478
Sponsors and Collaborators
University Hospital, Akershus
University of Oslo, Faculty of Medicine
Asker & Baerum Hospital
Sykehuset Innlandet HF
Vestre Viken Hospital Trust
Sophies Minde Ortopedi AS
Investigators
Study Chair: Torbjørn Omland, Professor University Hospital, Akershus
  More Information

Publications:

Responsible Party: Filip C Dolatowski, Principal Investigator, University Hospital, Akershus
ClinicalTrials.gov Identifier: NCT01770769     History of Changes
Other Study ID Numbers: NEM-2011/2296
Study First Received: April 25, 2012
Last Updated: January 17, 2013
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by University Hospital, Akershus:
Femoral Neck Fracture
undisplaced
minimally displaced
internal fixation
hemiarthroplasty
harris hip score
hospital cost
society cost
life quality
functional outcome

Additional relevant MeSH terms:
Femoral Neck Fractures
Fractures, Bone
Wounds and Injuries
Hip Fractures
Femoral Fractures
Leg Injuries
Dalteparin
Heparin, Low-Molecular-Weight
Cloxacillin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Anti-Bacterial Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on September 22, 2014