Mode
Text Size
Log in / Sign up
N/A N=130 Randomized Treatment

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

Femoral Neck Fracture

Enrolled (actual)
130
Serious AEs
1.5%
Results posted
Aug 2018
Primary outcome: Primary: Mortality — 23.1; 20.1 pecent

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Cemented Hip Hemiarthroplasty (Device); VerSys Beaded FullCoat, Zimmer (Device)
Age
Adult, Older Adult · 55+ yrs
Sex
All
Sponsor
Hartford Hospital
Primary completion
May 2009

Outcome Measures

OutcomeResultp-value
PRIMARY
Mortality
23.1; 20.1
PRIMARY
Post-Operative Unstable Angina
PRIMARY
Post-Operative Myocardial Infarction
SECONDARY
Instrumental Activities of Daily Living (IADL) and Physical Activities of Daily Living (PADL) Scale
SECONDARY
Energy/Fatigue Scale

Summary

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.

Eligibility Criteria

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01114646). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

Back to search