Hemi Artificial Hipjoint Versus Total Artificial Hipjoint

Phase 4

Completed

• Conditions: Optimized Treatment
• Interventions: Procedure: Hemi (hemialloplastik)

• Registration Number: NCT01432691
• Lead Sponsor: Hvidovre University Hospital

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2010-06
• Primary Completion: 2011-06
• Study First Submitted: 2011-09-09
• Study First Submitted QC: 2011-09-12
• Study First Posted: 2011-09-13
• Study Completion: 2015-06
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-17
• Last Update Posted: 2017-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Surgery	Hemi (hemialloplastik)	RSA study on hemi

Primary Outcome Measures

Name	Time	Method
Radiographic and clinical	Five years	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.

Secondary Outcome Measures

Name	Time	Method
Clinical	Five years	Implant Placement: Mobilisation: Patient mobilization level before the fracture is assessed by the New Mobility Score.Under hospital assessed patients' ability to time with current time instrument daily using the Cumulated ambulation score (CAS).; Bleeding: Perioperative bleeding set in operation description from start to suture the incision closed. Hgb is measured as standard on the third day in all patients in the hip fracture unit. In addition, registered the need for blood transfusions in the first four postoperative days.

Trial Locations

Locations (1)

Hvidovre University Hospital, Copenhagen; 🇩🇰 Copenhagen, Hvidovre, Denmark