Hemi Artificial Hipjoint Versus Total Artificial Hipjoint (THA)
|ClinicalTrials.gov Identifier: NCT01432691|
Recruitment Status : Completed
First Posted : September 13, 2011
Last Update Posted : April 18, 2017
|Condition or disease||Intervention/treatment||Phase|
|Optimized Treatment||Procedure: Hemi (hemialloplastik)||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||70 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||Clinical and RSA Comparison of Hemi Versus Total Hip Arthroplasty After Displaced Femoral Neck Fracture. A Randomized Double-Blind Study|
|Study Start Date :||June 2010|
|Actual Primary Completion Date :||June 2011|
|Actual Study Completion Date :||June 2015|
RSA study on hemi
Procedure: Hemi (hemialloplastik)
THA vs hemi
Other Name: BFX: Biomet CE-number: 00520
- Radiographic and clinical [ Time Frame: 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.
- Clinical [ Time Frame: Five years ]
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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01432691
|Hvidovre University Hospital, Copenhagen|
|Copenhagen, Hvidovre, Denmark, 2650|