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| ID | Type | Description | Link |
|---|---|---|---|
| MEC 02-072 | Other Identifier | METC MUMC Maastricht |
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| Name | Class |
|---|---|
| Stryker Orthopaedics | INDUSTRY |
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Thr purpose of this study is to compare the clinical and radiological results, as well as the femur bone density measurements of two uncemented total hip prostheses during 5 years of follow up.
It is of great importance for the function of uncemented total hip arthroplasty that the anchorage of the prosthesis in the bone of the femur is sufficient. This is of great importance in the prevention of stress shielding of the bone and to insure tranfer of forces from the prosthesis to the femur.
The symax hip stem is developed to optimize stress tranfer to bone and insure mechanical stability.
In this study the symax hip stem is compared to the HA_Omnifit hip stem (a frequently used and long term evaluated uncemented hip prosthesis) During the fist two years of follow up DEXA mesurments of bone mineral density are performed. Also patient satisfaction, patient fuction score and radiological evaluation measurements are done during 5 years of follow up.
Our primary objective is: comparison of the short term bone remodelling surrounding the Symax hip stem to the short term remodeling surrounding the Stryker Omnifit HA hip stem measured by bone densitometry, clinical and radiographic evaluation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HA-Omnifit | Active Comparator | Patients who receive a HA-Omnifit uncemented hip stem |
|
| Symax hip stem | Active Comparator | Patients with the Symax uncemented hip stem |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| uncemented total hip arthroplasty | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| short term bone remodeling | Bone remodeling is determined by measuring the Bone mineral density during time | 6 times within 2 years |
| complications and reoperations | Reporting all complications and reoperations of the two different hip prostheses | during 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| clinical performance | Comparison of the clinical performance of the two different hip prostheses | 9 times within 5 years |
| Radiological evaluation | Evaluation of Xrays according to the engh classifications |
| Measure | Description | Time Frame |
|---|---|---|
| patient satisfaction | comparison of patient satisfaction between the two different prostheses | 9 times within 5 years |
Inclusion Criteria:Male or non pregnant female patients >18 years
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lodewijk van Rhijn | azM | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24378381 | Derived | ten Broeke RH, Tarala M, Arts JJ, Janssen DW, Verdonschot N, Geesink RG. Improving peri-prosthetic bone adaptation around cementless hip stems: a clinical and finite element study. Med Eng Phys. 2014 Mar;36(3):345-53. doi: 10.1016/j.medengphy.2013.12.006. Epub 2013 Dec 27. |
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| 9 times within 5 years |