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

Hartford Hospital

Status: Completed

Conditions: Femoral Neck Fracture

Treatments: Device: Cemented Hip Hemiarthroplasty; Device: VerSys Beaded FullCoat, Zimmer

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01114646

03001334HU

124013 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 130 patients

Sex: All

Ages: 55+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

130 participants in 2 patient groups

Cemented Hip Hemiarthroplasty

Other group

Description:

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

Treatment:

Device: Cemented Hip Hemiarthroplasty

Press-Fit Hip Hemiarthroplasty

Experimental group

Description:

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

Treatment:

Device: VerSys Beaded FullCoat, Zimmer