Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2025-12-26 @ 12:25 AM
Study NCT ID:
NCT01690260
Status:
COMPLETED
Last Update Posted:
2017-10-05
First Post:
2012-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Parallel Study Between BMP-2 and Autologous Bone Graft After Ilizarow Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D055396', 'term': 'Bone Morphogenetic Protein 2'}], 'ancestors': [{'id': 'D019485', 'term': 'Bone Morphogenetic Proteins'}, {'id': 'D055411', 'term': 'TGF-beta Superfamily Proteins'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2017-10-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-04', 'studyFirstSubmitDate': '2012-09-12', 'studyFirstSubmitQcDate': '2012-09-17', 'lastUpdatePostDateStruct': {'date': '2017-10-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-09-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-10-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visible radiological signs of healing after 6 months.', 'timeFrame': 'An expected average of 6 months', 'description': 'Radiological signs of healing is a criteria for a successful result.\n\nFailure of healing after 6 months and/or a need for stimulant bone healing intervention can result in:\n\n* Dynamic measurement af immobilization\n* Ultrasound stimulation\n* Re-surgery with application of bone graft or bone replacement'}], 'secondaryOutcomes': [{'measure': 'Change in serologic bone markers', 'timeFrame': 'An expected average of 6 months', 'description': 'Blood tests will be analyzed 1,2,3,4,6,9 and 12 months after operation in order to registrating a change in serologic bone markers.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Bone', 'Morphogenetic', 'Protein', 'Ilizarow', 'Autologous', 'Osteoarthritis'], 'conditions': ['Bone Degenerative Changes', 'Osteoarthritis', 'Degenerative Disorder of Bone']}, 'descriptionModule': {'briefSummary': "Results of growth factors indicate that Bone Morphogenetic Proteins (BMP) have an exceptional ability to stimulate different characteristics of mesenchymale cells to osseous cells. Local application of BMP results in an increase of osseous tissue regardless of the location of the growth factor.\n\n5 years clinical studies show that BMP's can stimulate an increase of osseous tissue and improve clinical results when autologous bone graft is reduced or removed.\n\nThe purpose of this study is to examine whether recombinant growth factor BMP-2 can replace autologous bone graft in order to stimulating ossification during transplantation of osseous tissue."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hospitalised for autologous bone graft based on Ilizarow treatment.\n* Age between 20 and 70 years.\n\nExclusion Criteria:\n\n* Rheumatoid osteoarthritis\n* Malignant disease\n* Current hormone treatment (glucocorticoid, parathyreoidea, thyreoidea)\n* Pregnancy\n* Abuse of drugs and alcohol\n* Need of long-term NSAID treatment\n* Breastfeeding women'}, 'identificationModule': {'nctId': 'NCT01690260', 'briefTitle': 'Parallel Study Between BMP-2 and Autologous Bone Graft After Ilizarow Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Northern Orthopaedic Division, Denmark'}, 'officialTitle': 'Bone Morphogenetic Protein-2 Increase as Substitute for Autologous Bone Graft After Ilizarow Treatment for Arthritis and Degenerative Bones.', 'orgStudyIdInfo': {'id': 'N-20040019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bone Morphogenetic Protein 2', 'description': 'Condition of bone healing will be evaluated at serial radiological examinations and by clinical results according to a standard score system.', 'interventionNames': ['Drug: Bone Morphogenetic Protein 2', 'Procedure: Autologous bone graft']}, {'type': 'EXPERIMENTAL', 'label': 'Autologous bone graft', 'description': 'Condition of bone healing will be evaluated at serial radiological examinations after 1,2,3,4,5,6,9 and 12 months. Blood tests and urine samples will also be examined for monitoring the bone healing process.', 'interventionNames': ['Drug: Bone Morphogenetic Protein 2', 'Procedure: Autologous bone graft']}], 'interventions': [{'name': 'Bone Morphogenetic Protein 2', 'type': 'DRUG', 'otherNames': ['No other names.'], 'description': '12 mg recombinant BMP-2 combined with an injection of 1-2 g collagen type 1.', 'armGroupLabels': ['Autologous bone graft', 'Bone Morphogenetic Protein 2']}, {'name': 'Autologous bone graft', 'type': 'PROCEDURE', 'otherNames': ['No other names.'], 'description': 'Autologous bone graft in connection with bone docking operation.', 'armGroupLabels': ['Autologous bone graft', 'Bone Morphogenetic Protein 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Aalborg', 'country': 'Denmark', 'facility': 'Orthopaedic Surgery Research Unit, Aalborg University Hospital', 'geoPoint': {'lat': 57.048, 'lon': 9.9187}}], 'overallOfficials': [{'name': 'Knud S. Christensen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Orthopaedic Surgery Research Unit, Aalborg University Hospital, Denmark'}, {'name': 'David Donnell, Advisor', 'role': 'STUDY_CHAIR', 'affiliation': 'Medtronic Inc., Watford'}, {'name': 'Hans H. Hoeck, MD, Ph.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Center for Clinical and Basic Research, Aalborg, Denmark (CCBR A/S)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northern Orthopaedic Division, Denmark', 'class': 'OTHER'}, 'collaborators': [{'name': 'Medtronic', 'class': 'INDUSTRY'}, {'name': 'Center for Clinical and Basic Research (CCBR A/S).', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}