The Effect of Implant Coating (BoneMaster) on Migration and Clinical Outcome in Hip Arthroplasty … (NCT02311179) | Clinical Trial Compass
UnknownNot Applicable
The Effect of Implant Coating (BoneMaster) on Migration and Clinical Outcome in Hip Arthroplasty With the Exceed Cup
Denmark56 participantsStarted 2013-01
Plain-language summary
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.
Who can participate
Age range55 Years – 75 Years
SexALL
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Inclusion criteria
✓. Symptomatic radiographic osteoarthritis
✓. Radiographically and clinically adequate bone quality with regard to a total hip prosthesis, including osteoporosis-Dexa-Scanning verification.
✓. Age 55 to 75 years
✓. Informed written consent
Exclusion criteria
✕. Other disease of affected hip than primary coxarthrosis at time of inclusion 1.1. Secondary osteoarthritis 1.1.1. sequelae after acetabular fracture 1.1.2. hip-near femoral fracture 1.1.3. calve perthe 1.1.4. dysplasia (severe) 1.1.5. other 1.2 Atraumatic caput necrosis
✕. Neuromuscular or vascular condition in one or the other lower extremity
✕. Immobilization postoperative for long periods, for instance because of other serious diseases, alloplasties of the other lower-extremity joint, etc (decided by investigator)
✕. Reoperation of affected hip because of 4.1 luxation (with closed or open reduction) 4.2 deep infection 4.3 fracture 4.4 aseptic loosening 4.5 other
✕. Body Mass Index (BMI) at time of inclusion 81-84 5.1 ≥ 35 kg/m2 (grade 2+3 85, Obese Class I 81) 5.2 \< 18,5 kg/m2 81-84
✕. Insufficient RSA marker spread or rigidity Operative
✕. Use of component other than Bimetric femoral stem (HA porous-coated without collar)
What they're measuring
1
Radiographic: Migration of the acetabular component (mm, degree) with Model-Based RSA (m-RSA)