NCT00746876

Brief Summary

Hemiarthroplasty of the hip is standard treatment of femoral neck fractures (hip fractures). Hemiarthroplasty means replacing the hip joint with a metal prosthesis. Unipolar prostheses has a one-piece design where the hip movement occurs between the prosthesis and the acetabulum (hip socket). A bipolar prosthesis has an additional artificial joint between the two components of the prosthesis. Both treatments are clinically proven and common around the world. No clinical trial has proven benefits of one or the other prosthesis design. The investigators want to measure the differences in acetabular wear using these two prostheses, using radiostereometric measurements.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 3, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 4, 2008

Completed
12 months until next milestone

Study Start

First participant enrolled

September 1, 2009

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

April 19, 2016

Status Verified

April 1, 2016

Enrollment Period

3.3 years

First QC Date

September 3, 2008

Last Update Submit

April 18, 2016

Conditions

Hip Fractures

Keywords

HipFractureFemoral neckHemiarthroplastyBipolarUnipolarDisplaced femoral neck fractures

Outcome Measures

Primary Outcomes (1)

  • Acetabular wear measured with radiostereometry

    24 months

Secondary Outcomes (2)

  • Harris hip score

    24 months

  • Health-related quality of life (eq-5d)

    24 months

Study Arms (2)

Unipolar

ACTIVE COMPARATOR

15 patients randomized for treatment with a unipolar hip hemiarthroplasty

Device: Unipolar hip hemiarthroplasty

Bipolar

ACTIVE COMPARATOR

15 patients randomized for treatment with a bipolar hip hemiarthroplasty

Device: Bipolar hip hemiarthroplasty

Interventions

Unipolar hip hemiarthroplastyDEVICE

Unipolar hip hemiarthroplasty for the treatment of femoral neck fractures

Also known as: Modular Cathcart Unipolar, DePuy/Johnson and Johnson
Unipolar
Bipolar hip hemiarthroplastyDEVICE

Bipolar hip hemiarthroplasty for the treatment of femoral neck fractures

Also known as: Celf-Centering Bipolar, DePuy/Johnson and Johnson
Bipolar

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Displaced femoral neck fracture
  • years or older
  • Ambulatory status: No walking aids
  • No mental illness or impaired cognitive function

You may not qualify if:

  • Pathological fracture (malignant disease)
  • Ongoing systemic or local infection
  • Radiologically presence of acetabular wear (osteoarthrosis)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asker and Baerum Hospital

Baerum, Rud, 1309, Norway

Location

MeSH Terms

Conditions

Hip FracturesFractures, Bone

Condition Hierarchy (Ancestors)

Femoral FracturesWounds and InjuriesHip InjuriesLeg Injuries

Study Officials

  • Asbjørn Hjall, M.D.

    Asker and Baerum hospital, Norway

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

September 3, 2008

First Posted

September 4, 2008

Study Start

September 1, 2009

Primary Completion

December 1, 2012

Study Completion

December 1, 2015

Last Updated

April 19, 2016

Record last verified: 2016-04

Locations

NO(1)