NCT01432691

Brief Summary

This is a Randomized Controlled Trial study comparing hemialloplastik versus total joint replacement.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jun 2010

Longer than P75 for phase_4

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

Study Start

First participant enrolled

June 1, 2010

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 13, 2011

Completed
3.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

April 18, 2017

Status Verified

April 1, 2017

Enrollment Period

1 year

First QC Date

September 9, 2011

Last Update Submit

April 17, 2017

Conditions

Optimized Treatment

Keywords

Hip-fractureRSA

Outcome Measures

Primary Outcomes (1)

  • Radiographic and clinical

    Migration / rotation: Migration is measured by X-ray Stereo Photogrammetric Analysis (RSA). Clinical assessment: The patient is assessed clinically using the WOMAC and EQ-5D.

    Five years

Secondary Outcomes (1)

  • Clinical

    Five years

Study Arms (1)

Surgery

OTHER

RSA study on hemi

Procedure: Hemi (hemialloplastik)

Interventions

Hemi (hemialloplastik)PROCEDURE

THA vs hemi

Also known as: BFX: Biomet CE-number: 00520
Surgery

Eligibility Criteria

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

You may qualify if:

  • Patients over 70 years, admitted two our hip-fracture department with a 3-4 Garden femoral neck fracture or a fracture Garden 1-2 with over 20-degree posterior tilt.
  • Preoperative New Mobility Score ≥ 6th
  • Patients must be able to speak and understand Danish.
  • Patients must be able to give informed consent and be cognitively intact (Hindsøe score ≥ 6).
  • Patients should be expected to be able to implement the postoperative controls. Patients should not be medically ill: ASA-score ≤ 3rd

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hvidovre University Hospital, Copenhagen

Copenhagen, Hvidovre, 2650, Denmark

Location

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

September 9, 2011

First Posted

September 13, 2011

Study Start

June 1, 2010

Primary Completion

June 1, 2011

Study Completion

June 1, 2015

Last Updated

April 18, 2017

Record last verified: 2017-04

Locations

DK(1)