Ignite Creation Date:
2025-12-25 @ 4:36 AM
Ignite Modification Date:
2025-12-26 @ 3:38 AM
Study NCT ID:
NCT01375218
Status:
COMPLETED
Last Update Posted:
2015-01-19
First Post:
2011-06-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Satisfaction Comparing Two Braces in the Treatment of Developmental Dysplasia of the Hip (DDH) in Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006618', 'term': 'Hip Dislocation, Congenital'}], 'ancestors': [{'id': 'D000082602', 'term': 'Developmental Dysplasia of the Hip'}, {'id': 'D009139', 'term': 'Musculoskeletal Abnormalities'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-01-16', 'studyFirstSubmitDate': '2011-06-15', 'studyFirstSubmitQcDate': '2011-06-16', 'lastUpdatePostDateStruct': {'date': '2015-01-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-06-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Resolution of instability', 'timeFrame': '3-4 week interval', 'description': 'Negative Barlow and Ortolani tests as well as improvement/normalization in ultrasound measured alpha angle and femoral head coverage'}], 'secondaryOutcomes': [{'measure': 'Resolution of instability', 'timeFrame': '6 month interval', 'description': 'Negative Barlow and Ortolani tests as well as improvement/normalization in ultrasound measured alpha angle and femoral head coverage'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Hip Dislocation, Congenital', 'Congenital Deformity of Hip Joint']}, 'referencesModule': {'references': [{'pmid': '36214650', 'type': 'DERIVED', 'citation': 'Dwan K, Kirkham J, Paton RW, Morley E, Newton AW, Perry DC. Splinting for the non-operative management of developmental dysplasia of the hip (DDH) in children under six months of age. Cochrane Database Syst Rev. 2022 Oct 10;10(10):CD012717. doi: 10.1002/14651858.CD012717.pub2.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to 1) evaluate the effectiveness of the Plastizote abduction brace compared to the Pavlik harness in the treatment of developmental dysplasia of the hip (DDH) and 2) compare parent/caregiver satisfaction between the Plastizote abduction brace and the Pavlik harness. The investigators hope to learn which brace treatment is best for a definable population so the appropriate brace can be chosen initially avoiding the time, expense, and frustration of a failed technique.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '2 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 0-2 months of age\n2. Nonterratological developmental dysplasia of the hip diagnosed by physical exam and standard of care ultrasound\n\nExclusion Criteria:\n\n1. Ages greater than 2 months\n2. Neurological condition\n3. Terratological congenital dysplasia of the hip diagnosed by physical exam and standard of care ultrasound\n4. Chromosomal abnormality'}, 'identificationModule': {'nctId': 'NCT01375218', 'briefTitle': 'Efficacy and Satisfaction Comparing Two Braces in the Treatment of Developmental Dysplasia of the Hip (DDH) in Infants', 'organization': {'class': 'OTHER', 'fullName': 'OrthoCarolina Research Institute, Inc.'}, 'officialTitle': 'Efficacy and Satisfaction Comparing Two Braces in the Treatment of DDH in Infants: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': '041101A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Plastizote Brace', 'interventionNames': ['Other: Plastizote Brace']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pavlik Brace', 'interventionNames': ['Other: Pavlik Brace']}], 'interventions': [{'name': 'Pavlik Brace', 'type': 'OTHER', 'description': 'Pavlik Brace', 'armGroupLabels': ['Pavlik Brace']}, {'name': 'Plastizote Brace', 'type': 'OTHER', 'description': 'Plastizote Brace', 'armGroupLabels': ['Plastizote Brace']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28209', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'OrthoCarolina Research Institute, OrthoCarolina, P.A.', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'OrthoCarolina Research Institute, Inc.', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}