An observational study in Open Fracture of Foot, sponsored by Chiang Mai University. Completed at 1 site in Thailand. Open to participants aged 20 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-09-22.
Sponsored by Chiang Mai University · Observational
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.
53 studies on the registry are indexed under Fractures, Open; 14 are open to participants now.
This study's enrollment of 44 is below the median of 93 across 13 observational studies indexed under Fractures, Open.
Browse Fractures, Open studies →Chiang Mai University is the lead sponsor of 119 studies on the registry; 12 are open to participants now.
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There were 44 volunteers from orthopedic and neurosurgical division.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
The groups were orthopedic patients and neurosurgical patients. The samples to fill the voiding space of bone and skull same as autografts.
Device: bone void filler
Bone void filler device prepared from porous starch-hydroxyapatite composites for bone regeneration
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.
Time frame: 6 months
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.
Time frame: 6 months
Plan to share: Yes — yes, we plan
The record gives a start of Feb 2014, a primary completion of Nov 2015 and a completion of Jan 2016. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.
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