Ignite Creation Date:
2025-12-24 @ 9:34 PM
Ignite Modification Date:
2026-02-20 @ 6:20 PM
Study NCT ID:
NCT04104932
Status:
UNKNOWN
Last Update Posted:
2019-09-26
First Post:
2019-06-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Surgical and Conservative Treatment in Isolated Minor Rib Fractures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012253', 'term': 'Rib Fractures'}], 'ancestors': [{'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D013898', 'term': 'Thoracic Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000070799', 'term': 'Open Fracture Reduction'}, {'id': 'D005593', 'term': 'Fracture Fixation, Internal'}], 'ancestors': [{'id': 'D005592', 'term': 'Fracture Fixation'}, {'id': 'D019637', 'term': 'Orthopedic Procedures'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}, 'targetDuration': '3 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-07', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2023-10-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-09-24', 'studyFirstSubmitDate': '2019-06-28', 'studyFirstSubmitQcDate': '2019-09-24', 'lastUpdatePostDateStruct': {'date': '2019-09-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-14', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Duration of return to normal activity', 'timeFrame': '3 months after operation or after injury', 'description': 'From day of injury to day of return to normal activity'}, {'measure': 'Pain score change at 1 week', 'timeFrame': 'Change from injury or operation at 1 week', 'description': 'Pain Visual analog scales (Pain VAS) to measure pain intensity. A 10 cm horizontal line will be shown and patients mark on the line representing their perception of their current state. The score range from 0 to 10, with following cutpoints: no pain (0 cm), mild pain(1-4 cm), moderate pain (5-7 cm), and severe pain (8-10 cm).'}, {'measure': 'Pain score change at 3 months', 'timeFrame': 'Change from injury or operation at 3 months', 'description': 'Pain Visual analog scales (Pain VAS) to measure pain intensity. A 10 cm horizontal line will be shown and patients mark on the line representing their perception of their current state. The score range from 0 to 10, with following cutpoints: no pain (0 cm), mild pain(1-4 cm), moderate pain (5-7 cm), and severe pain (8-10 cm).'}], 'secondaryOutcomes': [{'measure': 'Forced vital capacity (FVC) change', 'timeFrame': 'Change from injury or operation at 3 months', 'description': 'Pulmonary function testing with spirometry, using percent of the predicted value (%)'}, {'measure': 'Forced expiratory volume in the first second (FEV1) change', 'timeFrame': 'Change from injury or operation at 3 months', 'description': 'Pulmonary function testing with spirometry, using percent of the predicted value (%)'}, {'measure': 'Total lung capacity (TLC) change', 'timeFrame': 'Change from injury or operation at 3 months', 'description': 'Pulmonary function testing with spirometry, using percent of the predicted value (%)'}, {'measure': 'Peak expiratory flow (PEF) change', 'timeFrame': 'Change from injury or operation at 3 months', 'description': 'Pulmonary function testing with spirometry, in unit of liters per minute'}, {'measure': '36-Item Short Form Survey (SF-36) results', 'timeFrame': 'At 3 months after injury or operation', 'description': 'Quality of life will be evaluated via SF-36 questionnaire, and will be scored according to SF-36 scoring rules'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['surgical stabilization', 'conservative treatment'], 'conditions': ['Rib Fractures']}, 'referencesModule': {'references': [{'pmid': '30247228', 'type': 'BACKGROUND', 'citation': 'Liang YS, Yu KC, Wong CS, Kao Y, Tiong TY, Tam KW. Does Surgery Reduce the Risk of Complications Among Patients with Multiple Rib Fractures? A Meta-analysis. Clin Orthop Relat Res. 2019 Jan;477(1):193-205. doi: 10.1097/CORR.0000000000000495.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this research is to compare the outcomes of surgical stabilization and conservative treatment in patients with isolated minor rib fractures.', 'detailedDescription': 'Isolated minor rib fractures (IMRFs), which is defined by single or two isolated minor rib fractures caused by trauma or stress. Traditionally, rib fractures are managed mainly by surgical stabilization or conservative treatment. In 2018, a systemic review and meta-analysis for patients with multiple rib fractures had revealed a shorter duration of mechanical ventilation, shorter hospital length of stay, and fewer trauma-associated complications in the surgical group than in the non-surgical group. In contrast, IMRFs are seldom life threatening, and compared to extremity fractures, rib fractures do not require matching accurately. Thus, IMRFs are usually treated conservatively. However, the investigators have clinically observed that patients suffering severe pain due to progressive rib displacement may take longer to return to normal activity, have lower quality of life, and even an increased risk of complications. Moreover, limited studies discussed the efficacy of surgical interventions for IMRFs. Therefore, the investigators conduct a prospective observational cohort study to compare the outcomes of surgical stabilization and conservative treatment in patients with IMRFs. The investigators collect patients with IMRFs whose situation were both suitable for surgical and non-surgical interventions. After explanation, patients can decide to undergo conservative or surgical treatment by themselves. The investigators will follow up pain scores, chest X-ray, pulmonary function tests, and duration of return to normal activity. Those data will be statistically analyzed by two-tailed two-sample t-test. This prospective cohort study is supposed to provide more evidence for clinical decision making and optimal management of IMRFs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with isolated minor rib fractures', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient age ≥ 20 years old.\n* Patient was diagnosed with isolated minor rib fractures by thoracic surgeon.\n* Patient was suitable for both surgical stabilization and conservative treatment.\n\nExclusion Criteria:\n\n* Severe trauma associated to other systems.\n* Pathologic fractures: such as fracture due to metastasis or steroid therapy.\n* Unconsciousness or disturbed conscious level.'}, 'identificationModule': {'nctId': 'NCT04104932', 'briefTitle': 'Surgical and Conservative Treatment in Isolated Minor Rib Fractures', 'organization': {'class': 'OTHER', 'fullName': 'Taipei Medical University Shuang Ho Hospital'}, 'officialTitle': 'Comparison of the Outcomes of Surgical Stabilization and Conservative Treatment in Patients With Isolated Minor Rib Fractures: A Prospective Observational Cohort Study.', 'orgStudyIdInfo': {'id': 'N201903152'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Surgical group', 'description': 'Patients with isolated minor rib fractures received surgical stabilization.', 'interventionNames': ['Procedure: Open reduction and internal fixation']}, {'label': 'Conservative group', 'description': 'Patients with isolated minor rib fractures received conservative treatment, such as NSAIDs.'}], 'interventions': [{'name': 'Open reduction and internal fixation', 'type': 'PROCEDURE', 'description': 'Open reduction and internal fixation', 'armGroupLabels': ['Surgical group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Tung-Yu Tiong, MD', 'role': 'CONTACT', 'email': 'dr_tiong@yahoo.com', 'phone': '+886970747235'}], 'overallOfficials': [{'name': 'Tung-Yu Tiong, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Taipei Medical University Shuang Ho Hospital'}]}, 'ipdSharingStatementModule': {'timeFrame': 'as required', 'ipdSharing': 'YES', 'description': 'as required', 'accessCriteria': 'as required'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taipei Medical University Shuang Ho Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Attending surgeon of thoracic surgery', 'investigatorFullName': 'Tung-Yu, Tiong', 'investigatorAffiliation': 'Taipei Medical University Shuang Ho Hospital'}}}}