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Biodegradable scaffold is an accepted and commercialized medical alternative choice for bone regeneration. In this project we will used our new invention, porous starch- hydroxyapatite composite, for in vivo clinical trial.
The products were prepared from medical grade Thai rice starch mixed with high purity (>97%) hydroxyapatite powder from fresh cow bone, and already passed in vivo animal biocompatility test, then processed by freeze-drying. There were 44 volunteers from orthopedic and neurosurgical division, 4 and 40 patients, respectively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | The groups were orthopedic patients and neurosurgical patients. The samples to fill the voiding space of bone and skull same as autografts. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bone void filler | Device | Bone void filler device prepared from porous starch-hydroxyapatite composites for bone regeneration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bone voids repairing | The primary outcome will be assessed from satisfactory grading by operative nurses and surgeons. Add a convenient storage, package removal, contamination risk, unused material disposal, size appropriateness, tolerability by hand, ease to cut, stability when wet, weight, and disturbance to operative field. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Bone voids repairing | The short and long term safety and efficacy were assessed during real time operation, such as material dislodgement. Add a during follow up time for at least 1 months such as infection and allergic reaction by X-ray follow up assessment at 1, 3 and 6 months intervals, after operations. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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There were 44 volunteers from orthopedic and neurosurgical division.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Biomedical Materials and Ceramic Industrial Research Unit | Chiang Mai | Chiang Mai | 50200 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22820527 | Result | Holzapfel BM, Reichert JC, Schantz JT, Gbureck U, Rackwitz L, Noth U, Jakob F, Rudert M, Groll J, Hutmacher DW. How smart do biomaterials need to be? A translational science and clinical point of view. Adv Drug Deliv Rev. 2013 Apr;65(4):581-603. doi: 10.1016/j.addr.2012.07.009. Epub 2012 Jul 20. | |
| 21627784 | Result |
| Label | URL |
|---|---|
| Accessed 29 June 2016 | View source |
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yes, we plan
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| Dimitriou R, Jones E, McGonagle D, Giannoudis PV. Bone regeneration: current concepts and future directions. BMC Med. 2011 May 31;9:66. doi: 10.1186/1741-7015-9-66. |
| 11426886 | Result | Mendes SC, Reis RL, Bovell YP, Cunha AM, van Blitterswijk CA, de Bruijn JD. Biocompatibility testing of novel starch-based materials with potential application in orthopaedic surgery: a preliminary study. Biomaterials. 2001 Jul;22(14):2057-64. doi: 10.1016/s0142-9612(00)00395-1. |