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

NCT ID: NCT01114646

Last Updated: 2018-08-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-03-31
• Study Completion Date: 2009-05-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cemented Hip Hemiarthroplasty

This arm received a hemiarthroplasty with a cemented femoral prosthesis (VerSys LD/Fx, Zimmer, Warsaw, IN).

Group Type: OTHER

Cemented Hip Hemiarthroplasty

Intervention Type: DEVICE

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

Press-Fit Hip Hemiarthroplasty

This arm received a press-fit hemiarthroplasty (VerSys Beaded FullCoat, Zimmer, Warsaw, IN),

Group Type: EXPERIMENTAL

VerSys Beaded FullCoat, Zimmer

Intervention Type: DEVICE

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

Interventions

Cemented Hip Hemiarthroplasty

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

Intervention Type: DEVICE

VerSys Beaded FullCoat, Zimmer

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zimmer Biomet

INDUSTRY

Sponsor Role: collaborator

Hartford Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joseph P. DeAngelis, MD

Role: STUDY_DIRECTOR

Hartford Hospital

Courtland G. Lewis, MD

Role: PRINCIPAL_INVESTIGATOR

Hartford Hospital

Locations

Hartford Hospital

Hartford, Connecticut, United States

Countries

United States

Other Identifiers

124013

Identifier Type: OTHER

Identifier Source: secondary_id

03001334HU

Identifier Type: -

Identifier Source: org_study_id