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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02910232

Enrollment

Registered

2016-09-22

Start date

2014-02-28

Completion date

2016-01-31

Last updated

2016-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Open Fracture of Foot

Keywords

Rice starch, Porous composite, Biomaterial, Bone regeneration, Clinical trial, Hydroxyapatite

Brief summary

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

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.

Interventions

DEVICEbone void filler

Bone void filler device prepared from porous starch-hydroxyapatite composites for bone regeneration

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

20 Years to 60 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Bone voids repairing	6 months	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.

Secondary

Measure	Time frame	Description
Bone voids repairing	6 months	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.

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026