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Completed

NCT Number: NCT01344772

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

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.

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Key information

Conditions

Femoral Neck Fracture Femoral Fractures Femoral Neck Fractures Fractures, Bone Hip Fractures Hip Injuries Leg Injuries Wounds and Injuries

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Danderyd Hospital

Stockholm, 182 88, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Internal fixation

Procedure

Two cannulated screws are placed under x-ray guidance

Total Hip Arthroplasty

Procedure

A total hip arthroplasty is performed through a standard posterior approach

Primary outcomes

  1. Harris hip score

    Time frame: 17 years

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

Secondary outcomes

  1. Reoperations and complications

    Time frame: 17 years

    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

Sponsors and collaborators

Lead sponsor

Danderyd Hospital

Other

Registry information

Official study title

Total Hip Arthroplasty Compared to Internal Fixation for Displaced Intracapsular Fractures of the Femoral Neck. A Randomized, Controlled Trial With a Seventeen Year Follow-up

Important dates

Study start
1990
Primary completion
2010
Study completion
2011
First posted
Apr 29, 2011
Registry last updated
Nov 27, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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