Osteoarthritis
Conditions
Keywords
Prosthesis fixation, hip arthroplasty
Brief 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.
Detailed description
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)
Interventions
DEVICEProsthesis, BoneMaster-Exceed cup (Biomet)
Patients will be randomized preoperatively to 1) Exceed cup coated with hydroxyapatite deposited electrochemically (BoneMaster) or 2) Exceed cup coated without hydroxyapatite coating.
DEVICEProsthesis Exceed cup without HA (Biomet)
Patients will be randomized preoperatively to 1) Exceed cup coated with hydroxyapatite deposited electrochemically (BoneMaster) or 2) Exceed cup coated without hydroxyapatite coating.
Sponsors
Biomet Denmark Aps
Project coordinator Orthopaedic Centre, Aarhus
Aarhus University Hospital
University of Aarhus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
55 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Symptomatic radiographic osteoarthritis 2. Radiographically and clinically adequate bone quality with regard to a total hip prosthesis, including osteoporosis-Dexa-Scanning verification. 3. Age 55 to 75 years 4. Informed written consent
Exclusion criteria
Orthopaedic 1. 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 2. Neuromuscular or vascular condition in one or the other lower extremity 3. Immobilization postoperative for long periods, for instance because of other serious diseases, alloplasties of the other lower-extremity joint, etc (decided by investigator) 4. 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 5. 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 6. Insufficient RSA marker spread or rigidity Operative 7. Use of component other than Bimetric femoral stem (HA porous-coated without collar) 8. Unsuitable bone quality for uncemented hip alloplasty, evaluated preoperatively 9. Complications peroperatively on insertion of hip alloplasty that necessitate deviation for the described operative procedure (see section: Operative procedure), among others 9.1 per- and postoperative fracture 9.2 bone graft used peroperatively (treatment of bone defects, cysts, etc.) 9.3 screw fixation of the acetabulum 9.4 gluteal detachment or extensive femoral exposure 9.5 trochanter osteotomy 9.6 Under-reaming 1-2 mm (cup size is one mm larger than the reamer, i.e. reaming 51 mm, cup 52 mm) 9.7 Other Radiographic 10. Cup placement 10.1 Cup inclination in AP (anteroposterior) plan \>56 degrees and \<35 degrees as evaluated on roentgenogram Medical 11. Osteoporosis 11.1. previously diagnosed 11.2. project-related preoperative DEXA (dual energy x-ray absorptiometry ) scan Patients with osteoporosis on the scan (T-score \< -2.5) are excluded from the study with referral to medical osteoporosis treatment. Patients with osteopenia (T-score \< -1) are included in the project with referral to osteoporosis prophylactic treatment. Patients with osteopenia at project inclusion are DEXA re-scanned at the 2 year follow up. 12. Arthritis 12.1. rheumatoid arthritis 12.2. psoriasis arthritis 12.3. other arthritides 13. Metabolic bone disease 13.1. hyperparathyroidism 13.2. Paget bone disease 13.3. renal osteodystrophy 13.4. other 14. Reduced kidney function thereby influencing bone metabolism 15. Previous treatment of skeleton with radiation therapy 16. Cancer Pharmaceuticals 17. Pharmaceuticals that effect calcium-phosphorus metabolism and bone density 87-98, either through intermittent administration or as a constant dose 17.1. glucocorticoids (systemic) beyond short-term treatment (\<5 days) 17.2. immunosuppression/modulation (cyclosporine, methotrexate, etc.) Compliance related 18. Absent patient compliance with treatment and follow-up investigations 19. Abuse that the investigator feels would weaken compliance 19.1. alcohol abuse 19.2. medication abuse 20. Psychological instability (including patient in treatment lithium/antidepressants/neuroleptics/ antipsychotic drugs) which the investigator feels would weaken compliance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Radiographic: Migration of the acetabular component (mm, degree) with Model-Based RSA (m-RSA) | End of study (up to 5 years) |
Secondary
| Measure | Time frame |
|---|---|
| Postoperative complications (up to 5 years) | End of study |
| HOOS (Hip disability and osteoarthritis outcome score) | End of study (up to 5 years) |
| OHS (Oxford Hip Score) | End of study (up to 5 years) |
| Reoperation of affected hips | End of study (up to 5 years) |
| VAS (Visual Analog Scale) at rest and load | End of study (up to 5 years) |
| EQ-5D (EuroQol) | End of study (up to 5 years) |
| Radiologic osteolysis | End of study (up to 5 years) |
| HHS (Harris Hip Score) on Range Of Motion (ROM) | End of study (up to 5 years) |
Countries
Denmark
Outcome results
None listed