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| Name | Class |
|---|---|
| Vejle Hospital | OTHER |
| Stryker Orthopaedics | INDUSTRY |
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The uncemented Symax hip stem is developed through optimization of the uncemented Omnifit hip stem. The Symax stem design combines an anatomical anteverted proximal geometry with a straight distal section. The proximal part is coated with a biomimetic hydroxyapatite (HA) coating for improved osseointegration to enhance load transfer and to minimize proximal bone loss. The distal part is treated with an anodization surface treatment in order to prevent distal bone apposition, which is expected to prevent distal loading and reduce proximal stress shielding. Aim of this study is to report mid-term clinical performance and evaluate whether the radiographic features are in line with the design principles of the Symax hip in an international clinical study with 5 years of follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Symax uncemented hip stem | Other | The Symax hip stem is an uncemented design forged from Ti6Al4V alloy (Stryker EMEA). Primary mechanical stability is provided by anatomical metaphyseal geometry. The hip stem features a size dependent anteversion, neck length and offset, with a CCD angle of 128°. Secondary biological stability is accomplished by fast osseous integration due to the BONIT-HA coating on the metaphyseal part of the stem. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Symax uncemented hip stem | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of Harris Hip Score (HHS) during follow-up | A hip specific functional score | Preoperative HHS and postoperatively change in HHS at 6 months, 1 year, 2 years, 3 years and 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Radiographic evaluations | Radiographic evaluations per Gruen zone and comparison between two assessment teams | Immediately postoperative radiograhpic evaluation as baseline and changes in radiography at follow-up 6 months, 1 year, 2 years, 3 years and 5 years we evaluated the radiograhip evaluations again |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22383318 | Result | ten Broeke RH, Hendrickx RP, Leffers P, Jutten LM, Geesink RG. Randomised trial comparing bone remodelling around two uncemented stems using modified Gruen zones. Hip Int. 2012 Jan-Feb;22(1):41-9. doi: 10.5301/HIP.2012.9103. | |
| 21586774 | Result | ten Broeke RH, Alves A, Baumann A, Arts JJ, Geesink RG. Bone reaction to a biomimetic third-generation hydroxyapatite coating and new surface treatment for the Symax hip stem. J Bone Joint Surg Br. 2011 Jun;93(6):760-8. doi: 10.1302/0301-620X.93B6.24986. |
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| ID | Term |
|---|---|
| D015207 | Osteoarthritis, Hip |
| D011475 | Prosthesis Failure |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| 30064453 | Derived | Kruijntjens DSMG, Kjaersgaard-Andersen P, Revald P, Leonhardt JS, Arts JJC, Ten Broeke RHM. 5-year clinical and radiographic follow-up of the uncemented Symax hip stem in an international study. J Orthop Surg Res. 2018 Jul 31;13(1):191. doi: 10.1186/s13018-018-0888-9. |
| D012216 |
| Rheumatic Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |