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

Completed

• Conditions: Open Fracture of Foot
• Interventions: Device: bone void filler

• Registration Number: NCT02910232
• Lead Sponsor: Chiang Mai University

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.

Study Timeline

• Study Start: 2014-02
• Primary Completion: 2015-11
• Study Completion: 2016-01
• Study First Submitted: 2016-08-31
• Status Verified: 2016-09
• Study First Submitted QC: 2016-09-18
• Last Update Submitted: 2016-09-18
• Study First Posted: 2016-09-22
• Last Update Posted: 2016-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	bone void filler	The groups were orthopedic patients and neurosurgical patients. The samples to fill the voiding space of bone and skull same as autografts.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Biomedical Materials and Ceramic Industrial Research Unit; 🇹🇭 Chiang Mai, Thailand