Hemi Artificial Hipjoint Versus Total Artificial Hipjoint

Optimized Treatment Clinical Trial

— THA  

Official title:

Clinical and RSA Comparison of Hemi Versus Total Hip Arthroplasty After Displaced Femoral Neck Fracture. A Randomized Double-Blind Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01432691
• Other study ID #: 19761979
• Status: Completed
• Phase: Phase 4
• First received: September 9, 2011
• Last updated: April 17, 2017
• Start date: June 2010
• Est. completion date: June 2015

Study information

• Verified date: April 2017
• Source: Hvidovre University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: June 2015
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Optimized Treatment

Intervention

Procedure:
• Hemi (hemialloplastik)
THA vs hemi

Locations

Country	Name	City	State
Denmark	Hvidovre University Hospital, Copenhagen	Copenhagen	Hvidovre

Sponsors (1)

Lead Sponsor	Collaborator
Hvidovre University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Clinical	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.	Five years