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

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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

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 Summary: 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.
Sponsor: Chiang Mai University

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome: 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.


Original Secondary Outcome: Same as current

Information By: Chiang Mai University

Dates:
Date Received: August 31, 2016
Date Started: February 2014
Date Completion:
Last Updated: September 18, 2016
Last Verified: September 2016