A Phase 4 interventional study of Hemi (hemialloplastik) in Optimized Treatment, sponsored by Hvidovre University Hospital. Completed at 1 site in Denmark. Open to participants aged 70 Years and older. Per ClinicalTrials.gov, last updated 2017-04-18.
Sponsored by Hvidovre University Hospital · Phase 4, Interventional, and Treatment
This is a Randomized Controlled Trial study comparing hemialloplastik versus total joint replacement.
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.
Hvidovre University Hospital is the lead sponsor of 295 studies on the registry; 21 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
RSA study on hemi
Procedure: Hemi (hemialloplastik)
THA vs hemi
Also known as: BFX: Biomet CE-number: 00520
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.
Time frame: Five years
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.
Time frame: Five years
This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.
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Hvidovre University Hospital