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

September 18, 2016 updated by: Sittiporn Punyanitya, Chiang Mai University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

44

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Chiang Mai, Thailand, 50200
        • Biomedical Materials and Ceramic Industrial Research Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

There were 44 volunteers from orthopedic and neurosurgical division.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1
The groups were orthopedic patients and neurosurgical patients. The samples to fill the voiding space of bone and skull same as autografts.
Device: bone void filler
Bone void filler device prepared from porous starch-hydroxyapatite composites for bone regeneration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chiang Mai University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (ACTUAL)

November 1, 2015

Study Completion (ACTUAL)

January 1, 2016

Study Registration Dates

First Submitted

August 31, 2016

First Submitted That Met QC Criteria

September 18, 2016

First Posted (ESTIMATE)

September 22, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

September 22, 2016

Last Update Submitted That Met QC Criteria

September 18, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0425/58

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

yes, we plan

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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