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CompletedNCT01344772Updated Nov 27, 2012

Total Hip Arthroplasty Compared to Internal Fixation for Displaced Intracapsular Fractures of the Femoral Neck

An interventional study of Internal fixation and Total hip arthroplasty in Femoral Neck Fracture, sponsored by Danderyd Hospital. Completed at 1 site in Sweden. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2012-11-27.

Sponsored by Danderyd Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
65 Years and older
Sex
All
01

Study summary

The primary aim of this study was to determine the Harris hip score as an evaluation of hip function, in mentally competent elderly patients (>65 years old) treated with either THR or IF, after contracting a displaced femoral neck fracture. The secondary aim was to compare the rate of reoperations and complications between the two groups.

02

Conditions studied

  • Femoral Neck Fracture

Keywords

  • femoral neck fracture
  • total hip arthroplasty
  • internal fixation
03

In context

Fractures, Bone

2,261 studies on the registry are indexed under Fractures, Bone; 325 are open to participants now.

This study's enrollment of 100 is above the median of 69 across 1,482 interventional studies indexed under Fractures, Bone.

Browse Fractures, Bone studies →

Lead sponsor

Danderyd Hospital is the lead sponsor of 58 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:

  • Acute displaced femoral neck fracture Garden III or IV,
  • Age over 65 years,
  • Admission from their own home,
  • No concurrent joint disease or previous fracture in the lower extremities,
  • Healthy or controlled medical conditions without significant systemic effects (ASA 1-2),
  • Harris hip score of 100
  • Acceptance from the patient to participate in the study.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (actual)

Study arms

  • Active comparator
    Internal fixation

    Displaced femoral neck fracture treated with internal fixation using two parallel cannulated screws.

    Procedure: Internal fixation

  • Active comparator
    Total hip replacement

    Displaced femoral neck fracture treated with total hip replacement through a posterior approach.

    Procedure: Total hip arthroplasty

Interventions

  • ProcedureInternal fixation

    Two cannulated screws are placed under x-ray guidance

  • ProcedureTotal hip arthroplasty

    A total hip arthroplasty is performed through a standard posterior approach

06

What researchers measure

Primary outcomes

  1. Harris hip score

    HHS index score of 0 indicates the worst possible function of the hip and a value of 100 indicates full function.

    Time frame: 17 years

Secondary outcomes

  1. Reoperations and complications

    IF group: nonunion, osteonecrosis, deep infection or fracture in the vicinity of the screws. Protruding screws or extraction of the screws when the fracture was healed was not defined as a complication. THR group: radiographic signs of loosening of the femoral- or acetabular component, dislocation, periprosthetic fracture or deep infection

    Time frame: 17 years

07

Study locations

1 site
  • Danderyd Hospital
    Stockholm, 182 88, Sweden
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 27, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01344772
Lead sponsor
Danderyd Hospital
Responsible party
Olof Skoldenberg (Consulatant Orthopaedic Surgeon, PhD, Danderyd Hospital) — Principal investigator
First posted
Apr 29, 2011
Start date
Feb 1990
Primary completion
Jun 2010
Completion
Jun 2011
Last update
Nov 27, 2012

Study contacts

Olof Sköldenberg, MD, PhD
principal investigator · Danderyd Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2012. You cannot join it, but the record below documents what was studied.

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