Skip to main content
OpenTrials
Completed

NCT Number: NCT02910232

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Open Fracture of Foot

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Biomedical Materials and Ceramic Industrial Research Unit

Chiang Mai, 50200, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

bone void filler

Device

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

Primary outcomes

  1. Bone voids repairing

    Time frame: 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 outcomes

  1. Bone voids repairing

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Chiang Mai University

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Sep 22, 2016
Registry last updated
Sep 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.