Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2025-12-26 @ 2:33 AM
Study NCT ID:
NCT04710602
Status:
COMPLETED
Last Update Posted:
2023-11-29
First Post:
2020-12-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prospective Follow up of Minimally Invasive Chest Wall Surgery After Trauma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-05-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-28', 'studyFirstSubmitDate': '2020-12-18', 'studyFirstSubmitQcDate': '2021-01-13', 'lastUpdatePostDateStruct': {'date': '2023-11-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Vital capacity of the lungs.', 'timeFrame': 'One year after surgery.', 'description': 'Vital capacity (VC) measured with spirometry.'}, {'measure': 'Forced vital capacity of the lungs.', 'timeFrame': 'One year after surgery.', 'description': 'Forced vital capacity (VC) measured with spirometry.'}, {'measure': 'Forced expiratory volume of the lungs.', 'timeFrame': 'One year after surgery.', 'description': 'Forced expiratory volume in 1 second (FEV1) measured with spirometry.'}, {'measure': 'Forced expiratory volume percent of the lungs.', 'timeFrame': 'One year after surgery.', 'description': 'Forced expiratory volume in 1 second divided with forced vital capacity, measured with spirometry.'}, {'measure': 'Peak expiratory flow of the lungs.', 'timeFrame': 'One year after surgery.', 'description': 'Peak expiratory flow measured with spirometry.'}], 'secondaryOutcomes': [{'measure': 'Disability', 'timeFrame': 'Six months and one year after surgery.', 'description': 'Degree of disability assessed with Disability Rating Index (DRI) scale ranging from 0-100 where higher scores indicate more disability.'}, {'measure': 'Physical activity', 'timeFrame': 'Six months and one year after surgery.', 'description': 'Physical activity assessed with Grimby activity scale ranging from 1-6 where 6 indicates the highest level of activity.'}, {'measure': 'Shoulder mobility', 'timeFrame': 'Six months and one year after surgery.', 'description': 'Shoulder mobility assessed with Boström index, a scale ranging from 5-30 for each shoulder where 30 represents the greatest range of movement.'}, {'measure': 'Respiratory movement', 'timeFrame': 'Six months and one year after surgery.', 'description': 'Movement of chest wall during respiration measured with Respiratory Movement Measuring Instrument (RMMI).'}, {'measure': 'Strength of respiratory muscles', 'timeFrame': 'Six months and one year after surgery.', 'description': 'Strength of respiratory muscles measured with Maximal Inspiratory Pressure (MIP) and Maximal Expiratory Pressure (MEP).'}, {'measure': 'Quality of life EQ-5D-5L', 'timeFrame': 'Six months and one year after surgery.', 'description': 'Quality of life assessed with the EuroQol (European Quality of Life) Five Dimension Five Level Scale (EQ-5D-5L). A 5-dimensional scale in which each dimension has 5 levels where 1 represents the best outcome and 5 represents the worst outcome.'}, {'measure': 'Radiological healing', 'timeFrame': 'One year after surgery.', 'description': 'Radiological signs of healing of the participants rib fractures assessed with CT scan. Fractures will be denoted as healed, partially healed or with no signs of healing.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chest wall', 'Trauma', 'Minimally invasive', 'Surgery', 'Muscle sparing'], 'conditions': ['Rib; Fracture, Multiple, With Flail Chest']}, 'referencesModule': {'references': [{'pmid': '26889439', 'type': 'BACKGROUND', 'citation': 'Bemelman M, van Baal M, Yuan JZ, Leenen L. The Role of Minimally Invasive Plate Osteosynthesis in Rib Fixation: A Review. Korean J Thorac Cardiovasc Surg. 2016 Feb;49(1):1-8. doi: 10.5090/kjtcs.2016.49.1.1. Epub 2016 Feb 5.'}, {'pmid': '27307787', 'type': 'BACKGROUND', 'citation': 'Caragounis EC, Fagevik Olsen M, Pazooki D, Granhed H. Surgical treatment of multiple rib fractures and flail chest in trauma: a one-year follow-up study. World J Emerg Surg. 2016 Jun 14;11:27. doi: 10.1186/s13017-016-0085-2. eCollection 2016.'}, {'pmid': '17670487', 'type': 'BACKGROUND', 'citation': 'Granetzny A, Abd El-Aal M, Emam E, Shalaby A, Boseila A. Surgical versus conservative treatment of flail chest. Evaluation of the pulmonary status. Interact Cardiovasc Thorac Surg. 2005 Dec;4(6):583-7. doi: 10.1510/icvts.2005.111807. Epub 2005 Sep 15.'}, {'pmid': '25642282', 'type': 'BACKGROUND', 'citation': 'Granhed HP, Pazooki D. A feasibility study of 60 consecutive patients operated for unstable thoracic cage. J Trauma Manag Outcomes. 2014 Dec 30;8(1):20. doi: 10.1186/s13032-014-0020-z. eCollection 2014.'}, {'pmid': '23415550', 'type': 'BACKGROUND', 'citation': 'Marasco SF, Davies AR, Cooper J, Varma D, Bennett V, Nevill R, Lee G, Bailey M, Fitzgerald M. Prospective randomized controlled trial of operative rib fixation in traumatic flail chest. J Am Coll Surg. 2013 May;216(5):924-32. doi: 10.1016/j.jamcollsurg.2012.12.024. Epub 2013 Feb 13.'}, {'pmid': '11956391', 'type': 'BACKGROUND', 'citation': 'Tanaka H, Yukioka T, Yamaguti Y, Shimizu S, Goto H, Matsuda H, Shimazaki S. Surgical stabilization of internal pneumatic stabilization? A prospective randomized study of management of severe flail chest patients. J Trauma. 2002 Apr;52(4):727-32; discussion 732. doi: 10.1097/00005373-200204000-00020.'}, {'pmid': '40392360', 'type': 'DERIVED', 'citation': 'Westin EO, Olsen MF, Caragounis EC. Comparison of long-term outcome between muscle sparing and non-muscle sparing surgical techniques in rib plating. Eur J Trauma Emerg Surg. 2025 May 20;51(1):212. doi: 10.1007/s00068-025-02881-z.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the outcome of a muscle sparing, minimally invasive open surgical technique for unstable ribcage injuries after trauma. The investigators will compare the results from the study participants to a historical cohort who were operated with a different surgical technique with large incisions and simultaneous thoracotomy.', 'detailedDescription': 'This is a prospective follow-up study where the investigators aim to study patients who have undergone surgery with a muscle sparing, minimally invasive technique for unstable ribcage after trauma. The investigators plan on seeing the participants as out patients 6 months and 1 year after surgery. The results will be compared to results from a historical cohort with patients who participated in earlier studies with a different surgical method with large incisions and simultaneous thoracotomy. The investigators plan on including 50 patients since a preliminary analysis has suggested this should be enough to notice statistically significant differences between the groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients surgically treated at our trauma ward for unstable chest wall due to trauma. Consecutive sampling.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with chest wall trauma who underwent surgical stabilisation for unstable chest wall using a minimally invasive, muscle sparing technique without thoracotomy or thoracoscopy no more than 6 months prior to inclusion.\n\nExclusion Criteria:\n\n* Severe head injury (Abbreviated Injury score (AIS) \\>3)\n* Spinal injury\n* Neurological or musculoskeletal disease affecting chest wall mobility'}, 'identificationModule': {'nctId': 'NCT04710602', 'briefTitle': 'Prospective Follow up of Minimally Invasive Chest Wall Surgery After Trauma', 'organization': {'class': 'OTHER', 'fullName': 'Sahlgrenska University Hospital'}, 'officialTitle': 'A Prospective Follow-up of Patients Treated With Muscle Sparing, Minimally Invasive Open Surgical Technique for Unstable Chest Wall After Trauma', 'orgStudyIdInfo': {'id': 'FoU-274457'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Minimally invasive', 'description': 'Patients who underwent surgery with a muscle sparing, minimally invasive technique for unstable chest wall after trauma.', 'interventionNames': ['Procedure: Minimally invasive surgical fixation of unstable rib cage']}, {'label': 'Historical control', 'description': 'Patients who underwent surgery with large incisions and simultaneous thoracotomy for unstable chest wall after trauma.', 'interventionNames': ['Procedure: Large incision surgical fixation of unstable rib cage.']}], 'interventions': [{'name': 'Minimally invasive surgical fixation of unstable rib cage', 'type': 'PROCEDURE', 'description': 'Minimally invasive and muscle sparing surgical fixation of ribs and/or sternum in an unstable segment of the chest wall (flail chest) with titan plates or medullary nails (MatrixRib Fixation System, DepuySynthes).', 'armGroupLabels': ['Minimally invasive']}, {'name': 'Large incision surgical fixation of unstable rib cage.', 'type': 'PROCEDURE', 'description': 'Surgical fixation of ribs and/or sternum in an unstable segment of the chest wall (flail chest) with titan plates or medullary nails (MatrixRib Fixation System, DepuySynthes). Large non muscle sparing incision with simultaneous thoracotomy.', 'armGroupLabels': ['Historical control']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Gothenburg', 'country': 'Sweden', 'facility': 'Sahlgrenska University Hospital', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}], 'overallOfficials': [{'name': 'Erik Westin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sahlgrenska University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Sharing data with other researchers will be considered by request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sahlgrenska University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Erik Öberg Westin', 'investigatorAffiliation': 'Sahlgrenska University Hospital'}}}}