A Prospective Randomized Trial of Uncemented Versus Cemented Hemiarthroplasty for Displaced Femoral Neck Fractures

NCT00491673 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 230

Last updated 2010-09-24

No results posted yet for this study

Summary

There is increasing evidence that primary hemiarthroplasty is the treatment of choice for displaced femoral neck fractures in the elderly

No definite conclusions have been made in regards to what kind of arthroplasty is favourable

Cemented implants are associated with increased risk of perioperative cardiovascular incidents and increased mortality.

Cementless implants are associated with increased postoperative pain and decreased walking ability.

This study investigates the differences between one well-documented cemented femoral stem and one well-documented uncemented femoral stem. Previous studies have mostly used uncemented stems with different designs.

Null hypothesis: No (less than 10 points) difference in HHS between groups at 1 year and 5 years

Conditions

  • Femoral Neck Fractures

Interventions

PROCEDURE

Uncemented primary bipolar hemiarthroplasty of the hip

Uncemented primary bipolar hemiarthroplasty of the hip

PROCEDURE

Cemented primary bipolar hemiarthroplasty of the hip

Cemented primary bipolar hemiarthroplasty of the hip

Sponsors & Collaborators

  • Asker & Baerum Hospital

    collaborator OTHER
  • Ullevaal University Hospital

    lead OTHER

Principal Investigators

  • Lars Nordsletten, Prof MD PhD · Ullevål University Hospital, University of Oslo

  • Wender Figved, MD, PhD · Asker and Baerum Hospital

  • Lars Nordsletten, Prof MD PhD · Ullevål University Hospital, University of Oslo

  • Ellen Langslet, MD · Ullevaal University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-09-30
Primary Completion
2010-12-31
Completion
2010-12-31

Countries

  • Norway

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 NCT00491673 on ClinicalTrials.gov