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

Open Fracture of Foot Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02910232
• Other study ID #: 0425/58
• Status: Completed
• Phase: Phase 3
• First received: August 31, 2016
• Last updated: September 18, 2016
• Start date: February 2014
• Est. completion date: January 2016

Study information

• Verified date: September 2016
• Source: Chiang Mai University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: January 2016
• Est. primary completion date: November 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 60 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Fractures, Open
• Open Fracture of Foot

Intervention

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

Locations

Country	Name	City	State
Thailand	Biomedical Materials and Ceramic Industrial Research Unit	Chiang Mai

Sponsors (1)

Lead Sponsor	Collaborator
Chiang Mai University

Country where clinical trial is conducted

Thailand, 

References & Publications (3)

Dimitriou R, Jones E, McGonagle D, Giannoudis PV. Bone regeneration: current concepts and future directions. BMC Med. 2011 May 31;9:66. doi: 10.1186/1741-7015-9-66. Review. — View Citation

Holzapfel BM, Reichert JC, Schantz JT, Gbureck U, Rackwitz L, Nöth U, Jakob F, Rudert M, Groll J, Hutmacher DW. How smart do biomaterials need to be? A translational science and clinical point of view. Adv Drug Deliv Rev. 2013 Apr;65(4):581-603. doi: 10.1 — View Citation

Mendes SC, Reis RL, Bovell YP, Cunha AM, van Blitterswijk CA, de Bruijn JD. Biocompatibility testing of novel starch-based materials with potential application in orthopaedic surgery: a preliminary study. Biomaterials. 2001 Jul;22(14):2057-64. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes

External Links

•   Accessed 29 June 2016