Osteoarthritis of the hip avascular femoral head necrosis coxarthrose heup arthose femurkop necrose
Conditions
Interventions
Curved Stemmed Total Hip Arthroplasty:
CFP Stem
Uncemented Straight Stemmed Total Hip Arthroplasty
Sponsors
Onze Lieve Vrouwe Gasthuis Amsterdam
Oosterpark 9
Postbus 95500
1090 HM Amsterdam
telephone: 0031-(0)20-5999111
Eligibility
Inclusion criteria
Inclusion criteria: Patients with disabling osteoarthritis of the hip who are not responding to conservative treatment for at least twelve months, who clinically fulfil the criteria to undergo a cementless total hip arthroplasty. 1. Male or female being 18 years or older 2. Patients meet the criteria for osteoarthritis: -Pain in one hip -Arthritic changes on radiograph: joint space narrowing, femoral / acetabular osteofytes, cysts and signs of sclerosis 3. Patients not responding to conservative therapy 4. Written informed consent for study participation
Exclusion criteria
Exclusion criteria: 1. Patients who are mentally impaired and not able to fill out questionnaires 2. Patients who do not know the Dutch or English or German language 3. Patients with a BMI of more than 40 4. Patients with skeletal immaturity 5. Patients with a life expectancy of less than 5 years 6. Patients with altered anatomy resulting in impossibility for the CFP procedure, according to the surgeon e.g.: -hip dysplasia with high luxation -post traumatic severe anatomic change -post-correction osteotomy 7. Patients with lower extremity amputation 8. Patients with an active malignant disease or current cytostatic treatment 9. Patients who are participating in another clinical trial 10. Known alcohol or drug abuse 11. Any condition that would impede measurement of efficacy to the opinion of the surgeon 12. Patients with a previous contralateral hip arthroplasty 13. Patients with contralateral hip pain 14. Avascular head necrosis due to sickelcel anemia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - The Dutch and the German version of the Hip disability and Osteoarthritis Outcome Score (HOOS). | — |
Secondary
| Measure | Time frame |
|---|---|
| * Composite outcome of re-operations or re-intervention Including: - Reduction of dislocation - Irrigation and debridement for infection - Open reduction of periprosthetic fractures - Revision - Bleeding / haematoma requiring surgical intervention - Any other planed or unplanned surgical intervention regarding the allocated implant. * complications Including: - Bleeding / vascular damage - Neurogenic damage - Fractures - Dislocation - Infection - Loosening - Deep venous thrombosis * Pain on a numeric rating scale (NRS) 0-10. (23) * The Short-Form (SF-36) 36 item questionnaire * The Oxford Hip Score * Position of the prosthesis: Roentgen: - Anterior Posterior pelvis roentgenogram with the feet in neutral alignment - With Zweymuller stems the holes in the trochanteric region need to be round in all x-rays. - X-hip faux profile | — |
Contacts
Public ContactR.W. Poolman
Onze Lieve Vrouwe Gasthuis Amsterdam Department of Orthopaedic Surgery Postbus 95500
Outcome results
None listed