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

November 1, 2017 updated by: Filip C Dolatowski, University Hospital, Akershus

Undisplaced Femoral Neck Fractures in Patients Aged 70 Years and Older: A Multicentre Randomised Controlled Trial Comparing Internal Fixation to Hemiarthroplasty

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

220

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Lillestrøm, Norway, N-1478
        • Akershus University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 70 years or older
  • Undisplaced or minimally displaced intracapsular femoral neck fracture (Garden I/II)
  • Patient able to walk before injury (all aids allowed)
  • Patient lives within the catchment area of the three involved centres

Exclusion Criteria:

  • Displaced fractures (Garden III/IV) and impacted fractures with minimal varus
  • Pathologic fracture
  • Current soft tissue or deep infection in the hip or pelvis area
  • ASA IV patients as classified by the anesthesiologist on call
  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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:
  • Cloxacillin or cephalothin perioperative prophylaxis
  • Fragmin (Dalteparin) anticoagulation for 2 wks
  • Hip Pins (R)
Experimental: Hemi - arthroplasty
cemented Hemi - arthroplasty (Exeter(R)) modular system V40 by Stryker. Refobacin cement.
Device: Hemi - arthroplasty
modular hemiarthroplasty
Other Names:
  • Hemiarthroplasty by Stryker - Exeter V40(R)
  • Hemiarthroplasty by DePuy - Corail
  • Refobacin® Bone Cement R & Biomet
  • Cloxacillin or cephalothin perioperative prophylaxis
  • Fragmin (Dalteparin) anticoagulation for 2 wks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Harris Hip Score of 10 points or more.
Time Frame: Baseline prior to fracture, 3 months, 1 year and 2 years
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.
Baseline prior to fracture, 3 months, 1 year and 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Euro-Quol 5 dimension (Eq5d)
Time Frame: Baseline prior to fracture, 3 months, 1 year and 2 years
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.
Baseline prior to fracture, 3 months, 1 year and 2 years
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
Visual analog scale variant with numbers from ranging from zero (no pain) to ten (worst possible pain). The investigator is blinded.
Two weeks prior to fracture (retrospective), at discharge at an average 3-5 days after surgery, after 3 months, 1 year and 2 years
Timed Up and Go test (TUG test)
Time Frame: 3 months, 1 year and 2 years
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.
3 months, 1 year and 2 years
Reoperation rate
Time Frame: 5 years after surgery
All complications are continually recorded in both trial arms.
5 years after surgery
Death
Time Frame: 5 years after surgery
All deaths are recorded
5 years after surgery
Mini mental state(MMSE-NR)
Time Frame: 3 months
Mini mental state is recorded only at 3 months follow-up
3 months
Hospital and society costs
Time Frame: at baseline prior to fracture, at discharge, 3 months, 1 year and 2 years
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.
at baseline prior to fracture, at discharge, 3 months, 1 year and 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Akershus

Collaborators

Vestre Viken Hospital Trust
University of Oslo
Asker & Baerum Hospital
Sykehuset Innlandet HF

Investigators

  • Study Chair: Torbjørn Omland, Professor, University Hospital, Akershus

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 6, 2012

Primary Completion (Anticipated)

February 6, 2020

Study Completion (Anticipated)

February 6, 2020

Study Registration Dates

First Submitted

April 25, 2012

First Submitted That Met QC Criteria

January 17, 2013

First Posted (Estimate)

January 18, 2013

Study Record Updates

Last Update Posted (Actual)

November 6, 2017

Last Update Submitted That Met QC Criteria

November 1, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NEM-2011/2296

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Data planned published in English in a peer-reviewed medical journal

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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