In Vivo Clinical Trial of Porous Starch - Hydroxyapatite Composite Biomaterials for Bone Regeneration

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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In Vivo Clinical Trial of Porous Starch - Hydroxyapatite Composite Biomaterials for Bone Regeneration

Conditions
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Open Fracture of Foot

Intervention / Treatment
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* Device: bone void filler


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A patient who requires treatment by surgery and product implant in bone. Not indicate sex type 18-65 years Patients accepted participate in the study. Type of surgery will be treat for only bone. Exclusion Criteria: Refused to join the study. Patients have an allergic history of carbohydrates and bovine bone.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>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<br>* Bone void filler device prepared from porous starch-hydroxyapatite composites for bone regeneration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rice starch, Porous composite, Biomaterial, Bone regeneration, Clinical trial, Hydroxyapatite