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

NCT01114646 | Completed Results

• 2 other identifiers: 03001334HU124013
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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

Keywords

Hemiarthroplasty; Cemented; Press Fit; Mortality; Morbidity; Functional Status; Displaced femoral neck fracture

Outcome Measures

Primary Outcomes (3)

• Mortality

  Assessment of post-operative mortality at one-year.

  1 year

• Post-Operative Unstable Angina

  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.

  1 week post-operation

• Post-Operative Myocardial Infarction

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

  1 week post-operation

Secondary Outcomes (2)

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

  1 year

• Energy/Fatigue Scale

  1 year

Study Arms (2)

Cemented Hip Hemiarthroplasty

OTHER

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

Device: Cemented Hip Hemiarthroplasty

Press-Fit Hip Hemiarthroplasty

EXPERIMENTAL

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

Device: VerSys Beaded FullCoat, Zimmer

Interventions

Cemented Hip Hemiarthroplasty DEVICE

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

Cemented Hip Hemiarthroplasty

VerSys Beaded FullCoat, Zimmer DEVICE

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

Press-Fit Hip Hemiarthroplasty

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hartford Hospital: lead
• Zimmer Biomet: collaborator

Study Sites (1)

Hartford Hospital

Hartford, Connecticut, 06106, United States

Location

MeSH Terms

Conditions

Femoral Neck Fractures

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Arben Ademi, CCRP
• Organization: Hartford Hostpial

arben.ademi@hhcealth.org

860-972-3561

Study Officials

• Joseph P. DeAngelis, MD

  Hartford Hospital

  STUDY DIRECTOR

• Courtland G. Lewis, MD

  Hartford Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2010
• First Posted: May 3, 2010
• Study Start: March 1, 2005
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: August 7, 2018
• Results First Posted: August 7, 2018

Record last verified: 2013-03

Locations

US (1)