Ignite Creation Date:
2025-12-24 @ 9:42 PM
Ignite Modification Date:
2026-01-13 @ 11:45 AM
Study NCT ID:
NCT02910232
Status:
COMPLETED
Last Update Posted:
2016-09-22
First Post:
2016-08-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
In Vivo Clinical Trial of Porous Starch - Hydroxyapatite Composite Biomaterials for Bone Regeneration
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-18', 'studyFirstSubmitDate': '2016-08-31', 'studyFirstSubmitQcDate': '2016-09-18', 'lastUpdatePostDateStruct': {'date': '2016-09-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-09-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bone voids repairing', 'timeFrame': '6 months', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Bone voids repairing', 'timeFrame': '6 months', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Rice starch', 'Porous composite', 'Biomaterial', 'Bone regeneration', 'Clinical trial', 'Hydroxyapatite'], 'conditions': ['Open Fracture of Foot']}, 'referencesModule': {'references': [{'pmid': '22820527', 'type': 'RESULT', 'citation': 'Holzapfel BM, Reichert JC, Schantz JT, Gbureck U, Rackwitz L, Noth 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: 10.1016/j.addr.2012.07.009. Epub 2012 Jul 20.'}, {'pmid': '21627784', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '11426886', 'type': 'RESULT', '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. doi: 10.1016/s0142-9612(00)00395-1.'}], 'seeAlsoLinks': [{'url': 'http://www.marketsandmarkets.com/pdfdownload.asp?id=728', 'label': 'Accessed 29 June 2016'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'There were 44 volunteers from orthopedic and neurosurgical division.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A patient who requires treatment by surgery and product implant in bone.\n* Not indicate sex type\n* 18-65 years\n* Patients accepted participate in the study.\n* Type of surgery will be treat for only bone.\n\nExclusion Criteria:\n\n* Refused to join the study.\n* Patients have an allergic history of carbohydrates and bovine bone.'}, 'identificationModule': {'nctId': 'NCT02910232', 'briefTitle': 'In Vivo Clinical Trial of Porous Starch - Hydroxyapatite Composite Biomaterials for Bone Regeneration', 'organization': {'class': 'OTHER', 'fullName': 'Chiang Mai University'}, 'officialTitle': 'In Vivo Clinical Trial of Porous Starch - Hydroxyapatite Composite Biomaterials for Bone Regeneration', 'orgStudyIdInfo': {'id': '0425/58'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'The groups were orthopedic patients and neurosurgical patients. The samples to fill the voiding space of bone and skull same as autografts.', 'interventionNames': ['Device: bone void filler']}], 'interventions': [{'name': 'bone void filler', 'type': 'DEVICE', 'description': 'Bone void filler device prepared from porous starch-hydroxyapatite composites for bone regeneration', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50200', 'city': 'Chiang Mai', 'state': 'Chiang Mai', 'country': 'Thailand', 'facility': 'Biomedical Materials and Ceramic Industrial Research Unit', 'geoPoint': {'lat': 18.79038, 'lon': 98.98468}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'yes, we plan'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chiang Mai University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Sittiporn Punyanitya', 'investigatorAffiliation': 'Chiang Mai University'}}}}