Status:
COMPLETED
Efficacy of a New Resurfacing Hip Prosthesis
Lead Sponsor:
Erasmus Medical Center
Collaborating Sponsors:
Johnson & Johnson
Conditions:
Osteoarthritis, Hip
Eligibility:
All Genders
18-60 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to compare the articular surface replacement (ASR) prosthesis placed by the conventional positioning method and the ASR prosthesis placed by 'computer assisted surgery' (C...
Detailed Description
For patients who suffer from end stage of osteoarthritis of the hip, a joint replacement could result in an obvious improvement of the quality of life. However, because of the life expectation and hig...
Eligibility Criteria
Inclusion
- Men aged ≤ 60 years, and women aged ≤ 55 years
- Presence of evident clinical and radiological osteoarthritis of the hip, indicated for a joint replacement surgery
Exclusion
- Evident osteoporosis
- Active local or systemic infection
- Clinical manifestation of vascular deficiency of the lower extremity
- Pathological condition of the acetabulum
- Presence of evident clinical and radiological avascular necrosis of the femoral head, hip dysplasia, slipped capital femoral epiphysis, Legg-Calve- Perthes disease
- Rheumatoid arthritis
- Extreme varus position (neck-shaft angle \< 110º)
- Presence of femoral cyst \> 1 cm in diameter
- Previous hip surgery
- Presence of bilateral hip pathology, which may lead to joint replacement surgery within 1 year
- Presence of a THR at the contra lateral site less than 6 months post- operatively or patients with a THR at the contra lateral site with a poor function of the hip
- BMI\> 30 kg/m2
- Renal deficiency (creatine \> 115 μmol/l for men and \> 90 μmol/l for women)
- Medically proven metal allergy
- Request of patient to correct an existing leg length discrepancy
- Head-neck ratio \< 1
- Use of steroids, and/or immunosuppressive medication
- Alcoholism
- Patients from which it is not sure that they will be able to attend the follow-up measurements
- Insufficient command of the Dutch language, spoken and/of written
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00391937
Start Date
October 1 2006
End Date
January 1 2013
Last Update
March 1 2013
Active Locations (6)
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1
Laurentius Hospital
Roermond, Limburg, Netherlands, 6043 CV
2
Maxima Medical Center, location Eindhoven
Eindhoven, North Brabant, Netherlands, 5600 PD
3
Medical Center Haaglanden, location Antoniushove
Leidschendam, South Holland, Netherlands, 2260 AK
4
Erasmus Medical Center
Rotterdam, South Holland, Netherlands, 3000 CA