This study focuses on the effect of the hydroxyapatite coating with BoneMaster on the fixation of the hip prosthesis in primary hip alloplasty. A hemispheric joint cup of the type Exceed cup (Biomet) characterized by a porous surface of titanium plasma spray is used. The surface is coated with hydroxyapatite deposited electrochemically (BoneMaster) and will be compared with an identical cup without hydroxyapatite.
This study focuses on the effect of the hydroxyapatite coating with BoneMaster on the fixation of the hip prosthesis in primary hip alloplasty. A hemispheric joint cup of the type Exceed cup (Biomet) characterized by a porous surface of titanium plasma spray is used. The surface is coated with hydroxyapatite deposited electrochemically (BoneMaster) and will be compared with an identical cup without hydroxyapatite. A 5-year radiologic analysis of migration will be carried out with the object of detecting prognostic evidence of prosthesis loosening. Migration is determined by Roentgen Stereo-photogrammetric Analysis (RSA) on stereoroentgenography. Simultaneously, the patients will be monitored by using the clinical outcome measure HOOS (Hip disability and osteoarthritis outcome score), OHS (Oxford Hip Score), EQ-5D (EuroQol), HHS (Harris Hip Score) on range of motion, VAS (Visual Analog Scale), postoperative complications and reoperation. Hypothesis: We expect that the Exceed cup with hydroxyapatite deposited electrochemically (BoneMaster) is superior or equal compared to a similar cup without hydroxyapatite regarding * mechanical stability (RSA) * (clinical outcome)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
56
Patients will be randomized preoperatively to 1) Exceed cup coated with hydroxyapatite deposited electrochemically (BoneMaster) or 2) Exceed cup coated without hydroxyapatite coating.
Patients will be randomized preoperatively to 1) Exceed cup coated with hydroxyapatite deposited electrochemically (BoneMaster) or 2) Exceed cup coated without hydroxyapatite coating.
Aarhus University Hospital
Aarhus, Denmark
Radiographic: Migration of the acetabular component (mm, degree) with Model-Based RSA (m-RSA)
Time frame: End of study (up to 5 years)
Reoperation of affected hips
Time frame: End of study (up to 5 years)
Postoperative complications (up to 5 years)
Time frame: End of study
HOOS (Hip disability and osteoarthritis outcome score)
Time frame: End of study (up to 5 years)
OHS (Oxford Hip Score)
Time frame: End of study (up to 5 years)
HHS (Harris Hip Score) on Range Of Motion (ROM)
Time frame: End of study (up to 5 years)
VAS (Visual Analog Scale) at rest and load
Time frame: End of study (up to 5 years)
EQ-5D (EuroQol)
Time frame: End of study (up to 5 years)
Radiologic osteolysis
Time frame: End of study (up to 5 years)
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