NCT00764153

Brief Summary

An estimated 1.6 million patients sustain a hip fracture every year, about half of these are intracapsular femoral neck fractures. A femoral neck fracture is a life changing event for any patient, and the risk of disability, increased dependence and death is substantial. The main treatment options for displaced femoral neck fractures are internal fixation and arthroplasty. It is established that there are more complications and reoperations after internal fixation, and better short term clinical results with arthroplasty, but knowledge about long term results is lacking.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
222

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2002

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2002

Completed
6 years until next milestone

First Submitted

Initial submission to the registry

September 29, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 1, 2008

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

October 23, 2014

Status Verified

October 1, 2014

Enrollment Period

9.1 years

First QC Date

September 29, 2008

Last Update Submit

October 22, 2014

Conditions

Femoral Neck Fractures

Keywords

Displaced Femoral Neck FracturesTreatmentFunctionPainQuality of lifeComplicationsReoperationsInternal FixationHemiarthroplastyActivities of Daily Living

Outcome Measures

Primary Outcomes (1)

  • Harris Hip Score

    5-6 years

Secondary Outcomes (3)

  • Eq-5d

    5-6 years

  • Barthel Index

    5-6 years

  • Reoperations and complications

    5-6 years

Study Arms (2)

Internal fixation

OTHER

Closed reduction and internal fixation with two parallel screws (Olmed)

Procedure: Internal fixation

Bipolar hemiarthroplasty

OTHER

Hemiarthroplasty with Charnley/ Hastings prosthesis

Procedure: Bipolar hemiarthroplasty

Interventions

Bipolar hemiarthroplastyPROCEDURE

Lateral approach. FWB.

Also known as: Charnley/Hastings
Bipolar hemiarthroplasty
Internal fixationPROCEDURE

Fluoroscopic Control. Percutaneous. FWB. Two parallel screws (Olmed)

Also known as: Olmed (DePuy)
Internal fixation

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Displaced femoral neck fracture
  • Age 60 or above
  • Able to walk (any aids allowed)

You may not qualify if:

  • Anesthesiologically unfit for arthroplasty surgery
  • Previous symptomatic hip pathology (i.e. arthritis)
  • Pathological fracture
  • Delay of more than 96 hours from injury to treatment
  • Not living in hospital area

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Frihagen F, Nordsletten L, Madsen JE. Hemiarthroplasty or internal fixation for intracapsular displaced femoral neck fractures: randomised controlled trial. BMJ. 2007 Dec 15;335(7632):1251-4. doi: 10.1136/bmj.39399.456551.25. Epub 2007 Dec 4.

    PMID: 18056740BACKGROUND

  • Frihagen F, Grotle M, Madsen JE, Wyller TB, Mowinckel P, Nordsletten L. Outcome after femoral neck fractures: a comparison of Harris Hip Score, Eq-5d and Barthel Index. Injury. 2008 Oct;39(10):1147-56. doi: 10.1016/j.injury.2008.03.027. Epub 2008 Jul 25.

    PMID: 18656868BACKGROUND

  • Stoen RO, Lofthus CM, Nordsletten L, Madsen JE, Frihagen F. Randomized trial of hemiarthroplasty versus internal fixation for femoral neck fractures: no differences at 6 years. Clin Orthop Relat Res. 2014 Jan;472(1):360-7. doi: 10.1007/s11999-013-3245-7. Epub 2013 Aug 24.

    PMID: 23975250BACKGROUND

MeSH Terms

Conditions

Femoral Neck FracturesPain

Interventions

Fracture Fixation, Internal

Condition Hierarchy (Ancestors)

Hip FracturesFemoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg InjuriesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fracture FixationOrthopedic ProceduresTherapeuticsSurgical Procedures, Operative

Study Officials

  • Jan Erik Madsen, MD PhD

    Orthopedic Center, Ulleval University Hospital, Oslo, Norway

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2008

First Posted

October 1, 2008

Study Start

October 1, 2002

Primary Completion

November 1, 2011

Study Completion

December 1, 2011

Last Updated

October 23, 2014

Record last verified: 2014-10