Hemi Artificial Hipjoint Versus Total Artificial Hipjoint

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2015-06-30

Brief Summary

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

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Detailed Description

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Seventy patients over seventy years who are admitted in our hip fracture department with the indication for hemi joint replacement therapy, due to a Garden 3-4 femoral neck fracture or a fracture Garden 1-2 with over 20-degree posterior tilt are randomized to either hemialloplastik or total joint replacement. The patients are followed for 24 mouths with X-ray Stereo Photogrammetric Analysis (RSA) radiographs and clinical examinations.

Conditions

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Optimized Treatment

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Surgery

RSA study on hemi

Group Type OTHER

Hemi (hemialloplastik)

Intervention Type PROCEDURE

THA vs hemi

Interventions

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Hemi (hemialloplastik)

THA vs hemi

Intervention Type PROCEDURE

Other Intervention Names

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BFX: Biomet CE-number: 00520

Eligibility Criteria

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Inclusion Criteria

* 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

Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No