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

Chiang Mai University

Status: Completed

Conditions: Open Fracture of Foot

Treatments: Device: bone void filler

Study type: Observational

Funder types: Other

Identifiers

NCT02910232

0425/58

Details and patient eligibility

About

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.

Full 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.

Enrollment: 44 patients

Sex: All

Ages: 20 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

44 participants in 1 patient group

1

Description:

The groups were orthopedic patients and neurosurgical patients. The samples to fill the voiding space of bone and skull same as autografts.

Treatment:

Device: bone void filler