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Completed

NCT Number: NCT00746876

Unipolar or Bipolar Hemiarthroplasty in the Treatment of Displaced Femoral Neck Fractures.

Hemiarthroplasty of the hip is standard treatment of femoral neck fractures (hip fractures). Hemiarthroplasty means replacing the hip joint with a metal prosthesis. Unipolar prostheses has a one-piece design where the hip movement occurs between the prosthesis and the acetabulum (hip socket). A bipolar prosthesis has an additional artificial joint between the two components of the prosthesis. Both treatments are clinically proven and common around the world. No clinical trial has proven benefits of one or the other prosthesis design. The investigators want to measure the differences in acetabular wear using these two prostheses, using radiostereometric measurements.

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Key information

Conditions

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

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Asker and Baerum Hospital

Baerum, Rud, 1309, Norway

About this study

Patients 70 years or older presenting to our hospital with an acute femoral neck fracture are eligible for inclusion. 15 patients in each group will be recruited. One group receives a unipolar hemiarthroplasty and 15 receives a bipolar arthroplasty. Tantalum markers are placed around the acetabulum during surgery. Follow-up intervals are at 3, 12 and 24 months with radiostereometric evaluation (radiographs) and clinical evaluation.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Displaced femoral neck fracture
  • 70 years or older
  • Ambulatory status: No walking aids
  • No mental illness or impaired cognitive function

Exclusion criteria

  • Pathological fracture (malignant disease)
  • Ongoing systemic or local infection
  • Radiologically presence of acetabular wear (osteoarthrosis)

Treatment and study plan

Unipolar hip hemiarthroplasty

Device

Unipolar hip hemiarthroplasty for the treatment of femoral neck fractures

Other names: Modular Cathcart Unipolar, DePuy/Johnson and Johnson

Bipolar hip hemiarthroplasty

Device

Bipolar hip hemiarthroplasty for the treatment of femoral neck fractures

Other names: Celf-Centering Bipolar, DePuy/Johnson and Johnson

Primary outcomes

  1. Acetabular wear measured with radiostereometry

    Time frame: 24 months

Secondary outcomes

  1. Harris hip score

    Time frame: 24 months

  2. Health-related quality of life (eq-5d)

    Time frame: 24 months

Sponsors and collaborators

Lead sponsor

Sykehuset Asker og Baerum

Other

Collaborators

  • Ullevaal University Hospital

Registry information

Official study title

Unipolar or Bipolar Hemiarthroplasty in the Treatment of Displaced Femoral Neck Fractures. A Randomized Trial of RSA Measurements of Acetabular Wear.

Acronym: HEMIUNIBIPOL

Important dates

Study start
2009
Primary completion
2012
Study completion
2015
First posted
Sep 4, 2008
Registry last updated
Apr 19, 2016

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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