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Completed

NCT Number: NCT01114646

Functional Status, Morbidity and Mortality in Cemented Versus Press-Fit Hemiarthroplasty

Hemiarthroplasty (half of a hip replacement) is the most common treatment for displaced fractures of the femoral neck in the elderly and is associated with a better functional outcome and fewer reoperations than internal fixation. Currently, the operative management of displaced femoral neck fractures favors the use of cemented implants. This technique is believed to be more stable in the immediate post-operative period, but there is limited evidence of a decreased morbidity and mortality with cemented versus press-fit stems (uncemented). In 2006, a meta-analysis concluded that the evidence was too limited to recommend a cemented or press-fit hemiarthroplasty.

In this investigation, the morbidity, mortality and functional outcome associated with cemented and press-fit hemiarthroplasty will be compared prospectively. We propose that the use of press-fit hemiarthroplasty in the treatment of displaced subcapital fractures of the femoral neck would be associated with a decreased risk of adverse peri-operative outcomes, and that the functional results of cemented and press-fit hemiarthroplasty will be equivalent at one year.

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Key information

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hartford Hospital

Hartford, Connecticut, 06106, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • older than 55 years
  • non-pathologic, displaced subcapital femoral neck fracture
  • designated for surgical reconstruction with a hemiarthroplasty by the attending surgeon
  • able to ambulate ten feet prior to presentation

Exclusion criteria

  • unable to walk ten feet prior to hip fracture
  • multiple extremity trauma
  • pathologic fracture of the hip (including malignancy)
  • clinically recognized acute myocardial infarction within thirty days prior to enrollment
  • previously participated in the trial
  • symptoms associated with anemia
  • pre-existing metabolic bone disease

Treatment and study plan

Cemented Hip Hemiarthroplasty

Device

The cemented femoral prosthesis is a VerSys LD/Fx, Zimmer, Warsaw, IN.

VerSys Beaded FullCoat, Zimmer

Device

The press-fit component is a VerSys Beaded FullCoat, Zimmer, Warsaw, IN,

Primary outcomes

  1. Mortality

    Time frame: 1 year

    Assessment of post-operative mortality at one-year.

  2. Post-Operative Unstable Angina

    Time frame: 1 week post-operation

    Unstable angina was defined as the new onset of prolonged chest pain (greater than or equal to 30 minutes) or two episodes of chest pain thought to be of cardiac origin or an electrocardiogram showing new T-wave inversion, ST depression or elevation with enzymes non-diagnostic of myocardial ischemia.

  3. Post-Operative Myocardial Infarction

    Time frame: 1 week post-operation

    Myocardial infarction required a positive troponin or electrocardiogram consistent with definite infarction.

Secondary outcomes

  1. Instrumental Activities of Daily Living (IADL) and Physical Activities of Daily Living (PADL) Scale

    Time frame: 1 year

    A modified version of the Older Americans Resources and Services Instrument (OARS) which asks about performance of tasks of daily living during the preceding two weeks.14 These activities include: getting to places, walking distances, shopping for groceries or clothes, preparing meals and doing housecleaning.

  2. Energy/Fatigue Scale

    Time frame: 1 year

    An inquire about fatigue, level of energy and self-efficiency.

Sponsors and collaborators

Lead sponsor

Hartford Hospital

Other

Collaborators

  • Zimmer Biomet

Registry information

Official study title

Functional Status, Morbidity and Mortality in Cemented Versus Uncemented Hemiarthroplasty for Subcapital Hip Fractures: A Prospective Randomized Trial

Important dates

Study start
2005
Primary completion
2009
Study completion
2009
First posted
May 3, 2010
Registry last updated
Aug 7, 2018

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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