Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00391937 | Efficacy of a New Resurfacing Hip Prosthesis | PHASE3 | COMPLETED | 150 | — | — | Oct 1, 2006 | Jan 1, 2013 | Mar 1, 2013 | 6 | Netherlands |
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | ASR prosthesis placed using CAS |
| 2 | ACTIVE_COMPARATOR | ASR prosthesis placed by conventional method |
| Name | Type | Description |
|---|---|---|
| Articular Surface Replacement (ASR) hip prosthesis | DEVICE | a DePuy ASR™ primary resurfacing femoral and acetabular component (DePuy International Ltd, Leeds, UK). The cement that will be used is one dose of DePuy SmartSet® GHV 40 gram, a high-viscosity cement with gentamycin (DePuy CMW, Blackpool, UK). Instrumentation includes standard ASR™ instruments and Ci™ Software for DePuy ASR™ System1.0. |
Inclusion Criteria: * 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 Criteria: * Evident osteoporosis * Active local or systemic infection * Clinical manifestation of vas...