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| Name | Class |
|---|---|
| Johnson & Johnson | INDUSTRY |
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' (CAS) in variation between pre planned position of the femoral component and the actual position of the femoral component of the prosthesis. The hypothesis is that this variation is larger with the conventional positioning method than when CAS is used.
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 high level of activity of young and active patients, the conventional total hip replacement does not offer an optimal solution.
An alternative to a total hip replacement in young and active patients is the resurfacing hip prostheses. The articular surface replacement (ASR) hip prostheses can be placed by the conventional positioning method and by using 'computer assisted surgery' (CAS). The hypothesis is that the positioning of the femoral component by the conventional positioning method will show a larger variation between pre planned and actual position than when CAS is used.
This study will compare the results of those who had an ASR prosthesis placed by the conventional positioning method with those patients in whom the ASR prosthesis was placed using CAS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | ASR prosthesis placed using CAS |
|
| 2 | Active Comparator | ASR prosthesis placed by conventional method |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| pre planned position of the femoral component preoperatively (stem-shaft-angle) | within 8 weeks before surgery | |
| actual position of the femoral component postoperatively (stem-shaft-angle) | within one week after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Harris Hip Score | preoperatively and at 6 weeks, 3, 12, 24 and 36 months postoperatively | |
| Hip pain | preoperatively and at 6 weeks, 3, 12, 24 and 36 months postoperatively | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| JAN Verhaar, PhD MD | Erasmus Medical Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laurentius Hospital | Roermond | Limburg | 6043 CV | Netherlands | ||
| Maxima Medical Center, location Eindhoven |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31651318 | Derived | Koper MC, Reijman M, van Es EM, Waarsing JH, Koot HWJ, Keizer SB, Jansen I, van Biezen FC, Verhaar JAN, Bos PK. No added value for Computer-Assisted surgery to improve femoral component positioning and Patient Reported Outcomes in Hip Resurfacing Arthroplasty; a multi-center randomized controlled trial. BMC Musculoskelet Disord. 2019 Oct 25;20(1):473. doi: 10.1186/s12891-019-2883-7. |
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| ID | Term |
|---|---|
| D015207 | Osteoarthritis, Hip |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D006622 | Hip Prosthesis |
| ID | Term |
|---|---|
| D007595 | Joint Prosthesis |
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
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|
| Assessments of the position of femoral component (biomechanical parameters) at the X-rays |
| preoperatively, during the clinical phase and at 6 weeks, 3, 12, 24 and 36 months postoperatively |
| Physical Activity Scale for Individuals with Physical Disabilities (PASIPD) | preoperatively and at 6 weeks, 3, 12, 24 and 36 months postoperatively |
| Percentage of dynamic and static activities measured by the Rotterdam Activity Monitor (RAM) | preoperatively and at 3 and 6 months postoperatively |
| Quality of life | preoperatively and at 6 weeks, 3, 12, 24 and 36 months postoperatively |
| Early complications | within 3 months after surgery |
| Later complications | longer than 3 months after surgery |
| Eindhoven |
| North Brabant |
| 5600 PD |
| Netherlands |
| Medical Center Haaglanden, location Antoniushove | Leidschendam | South Holland | 2260 AK | Netherlands |
| Erasmus Medical Center | Rotterdam | South Holland | 3000 CA | Netherlands |
| Medical Center Haaglanden, location Westeinde Hospital | The Hague | South Holland | 2501 CK | Netherlands |
| Oosterschelde Hospital | Goes | Zeeland | 4462 RA | Netherlands |
| D012216 |
| Rheumatic Diseases |