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

NCT01114646 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2018-08-07

Study results available
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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.

Conditions

  • Femoral Neck Fracture

Interventions

DEVICE

Cemented Hip Hemiarthroplasty

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

DEVICE

VerSys Beaded FullCoat, Zimmer

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

Sponsors & Collaborators

  • Zimmer Biomet

    collaborator INDUSTRY

  • Hartford Hospital

    lead OTHER

Principal Investigators

  • Joseph P. DeAngelis, MD · Hartford Hospital

  • Courtland G. Lewis, MD · Hartford Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-03-31
Primary Completion
2009-05-31
Completion
2009-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01114646 on ClinicalTrials.gov