Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2025-12-26 @ 1:18 AM
Study NCT ID:
NCT05959733
Status:
RECRUITING
Last Update Posted:
2025-02-18
First Post:
2023-07-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Maximal Repair Versus Bridging Reconstruction with BioBrace®
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070636', 'term': 'Rotator Cuff Injuries'}], 'ancestors': [{'id': 'D012421', 'term': 'Rupture'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D000070599', 'term': 'Shoulder Injuries'}, {'id': 'D013708', 'term': 'Tendon Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014945', 'term': 'Wound Healing'}], 'ancestors': [{'id': 'D012038', 'term': 'Regeneration'}, {'id': 'D001686', 'term': 'Biological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Participants will be unaware to the type of surgery that they received. The investigator will not be blinded, however, the individuals assessing the outcomes will be.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-12-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2027-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-14', 'studyFirstSubmitDate': '2023-07-05', 'studyFirstSubmitQcDate': '2023-07-17', 'lastUpdatePostDateStruct': {'date': '2025-02-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Radiographic or clinical failure', 'timeFrame': '2 years', 'description': 'The primary outcome measure for this study will be radiographic and/or clinical failure defined as a rotator cuff tear of equal or larger size than at baseline or does not meet WORC score MCID compared to baseline at any follow up'}], 'secondaryOutcomes': [{'measure': 'Acromiohumeral Distance', 'timeFrame': '2 year', 'description': 'Acromiohumeral distance (AHD) will be measured on pre- and post-operative x-rays.'}, {'measure': 'Muscle Atrophy', 'timeFrame': '2 year', 'description': "Using MRI, muscle atrophy will be measured using Warner's classification between groups."}, {'measure': 'Fatty Infiltration', 'timeFrame': '2 year', 'description': 'Fatty infiltration using the Goutallier classification will be used and identified'}, {'measure': 'Healing Rate', 'timeFrame': '2 year', 'description': 'To measure the structural integrity of the surgery, Sugaya method will be used.'}, {'measure': 'Western Ontario Rotator Cuff Index (WORC)', 'timeFrame': 'Baseline, 6-month, 1-year, 2-years', 'description': 'WORC will be measured pre-operatively, and post-operatively and 6-months, 1-year, and 2-years'}, {'measure': 'American Shoulder and Elbow Surgeon survey', 'timeFrame': 'Baseline, 6-month, 1-year, 2-years', 'description': 'American Shoulder and Elbow Surgeon survey will be measured pre-operatively, and post-operatively and 6-months, 1-year, and 2-years'}, {'measure': 'EQ-5D-5L', 'timeFrame': 'Baseline, 6-month, 1-year, 2-years', 'description': 'EQ-5D-5L for overall health will be measured pre-operatively, and post-operatively at 6-months, 1-year, and 2-years'}, {'measure': 'Range of motion', 'timeFrame': 'Baseline, 6-month, 1-year, 2-years', 'description': 'The range of motion, measured in degrees for flexion, extension, abduction, internal, and external rotation will be measured. These are measured and compared pre-operatively, and post-operatively and 6-months, 1-year, and 2-years'}, {'measure': 'Shoulder strength', 'timeFrame': 'Baseline, 6-month, 1-year, 2-years', 'description': 'The strength of patients flexion, extension, abduction, internal, and external rotation will be measured. These are measured and compared pre-operatively, and post-operatively and 6-months, 1-year, and 2-years'}, {'measure': 'Biomechanics and Muscle Activity', 'timeFrame': 'Baseline and 2 years', 'description': 'Pre- and post-operative (1-year) in-vivo biomechanics and electromyography will be compared between groups during a standardized shoulder lifting study in a laboratory based environment.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['shoulder', 'rotator cuff', 'clinical outcomes', 'radiographic outcomes', 'biomechanics', 'bridging reconstruction', 'rotator cuff repair'], 'conditions': ['Rotator Cuff Tears', 'Bioinductive Implant']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if using BioBrace® to reconstruct the gap in the rotator cuff tears lead to better results for patients compared to the traditional maximal repair method. This study will use a variety of clinical, radiographic, and functional outcome measures. Specifically, the researchers will be comparing the re-tear rate, patient reported outcomes, shoulder strength, range of motion, muscle activation, in-vivo biomechanics, and other radiographic outcomes using x-ray and MRI.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* magnetic resonance imaging (MRI) proven diagnosis of a large or massive (\\> 3cm), two-tendon (supraspinatus and infraspinatus) tear of the shoulder rotator cuff\n* over 18 years of age\n\nExclusion Criteria:\n\n* glenohumeral osteoarthritis\n* Western Ontario rotator cuff score \\>60\n* uncontrolled diabetes (Hgb A1C \\>7%)\n* pregnant\n* local or systemic infection\n* inability to cooperate with and/or comprehend post-operative instructions\n* MRI proven non-vascular sites\n* poor nutritional state (Alb \\<30 g/L)\n* cancer\n* paralysis of the shoulder\n* contracture of the shoulder\n* patients unable to provide informed consent for the study'}, 'identificationModule': {'nctId': 'NCT05959733', 'briefTitle': 'Maximal Repair Versus Bridging Reconstruction with BioBrace®', 'organization': {'class': 'OTHER', 'fullName': 'Nova Scotia Health Authority'}, 'officialTitle': 'Maximal Repair Versus Bridging Reconstruction with BioBrace® for the Treatment of Chronic, Massive Rotator Cuff Tears: Clinical, Radiographic, and In-vivo Biomechanical Analysis', 'orgStudyIdInfo': {'id': 'BioBridge'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Repair', 'description': 'This group will undergo a rotator cuff repair procedure.', 'interventionNames': ['Procedure: Repair']}, {'type': 'EXPERIMENTAL', 'label': 'Bridging Reconstruction using BioBrace', 'description': 'This experimental group will undergo bridging reconstruction using the bioinductive implant, BioBrace.', 'interventionNames': ['Procedure: Bridging Reconstruction using BioBrace']}], 'interventions': [{'name': 'Bridging Reconstruction using BioBrace', 'type': 'PROCEDURE', 'description': "Patients in the reconstruction group will undergo maximal repair with interposition bridging using BioBrace. This technique will follow a previously described technique by the principal investigator with differences allocated to the graft, it's preparation and insertion. The bursa will be debrided, and rotator cuff edged will be shaved down to stable tissue. BioBrace is bioinductive scaffold composed of highly porous type I collagen and bio-resorbable poly (L-lactide) (PLLA) microfilaments, and will be used as the graft in this trial.", 'armGroupLabels': ['Bridging Reconstruction using BioBrace']}, {'name': 'Repair', 'type': 'PROCEDURE', 'description': 'Patients in the maximal repair group will undergo a SCOI-row rotator cuff repair with adequate tension as described previously, with recreation of the rotator cable. Briefly, the SCOI-row rotator cuff repair uses one triple loaded suture anchor for each 1.2cm of torn tendon. This technique has been completed in a previous randomized controlled trial.', 'armGroupLabels': ['Repair']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'B3H2E1', 'city': 'Halifax', 'state': 'Nova Scotia', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Ivan Wong', 'role': 'CONTACT', 'email': 'research@drivanwong.com', 'phone': '9024737626'}], 'facility': 'Nova Scotia Health Authority', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}], 'centralContacts': [{'name': 'Sarah Remedios, MSc', 'role': 'CONTACT', 'email': 'research@drivanwong.com', 'phone': '9024737626'}], 'overallOfficials': [{'name': 'Ivan Wong, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nova Scotia Health Authority, Orthopaedic Surgeon'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nova Scotia Health Authority', 'class': 'OTHER'}, 'collaborators': [{'name': 'CONMED Corporation', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD Orthopaedic Surgeon', 'investigatorFullName': 'Ivan Wong, MD', 'investigatorAffiliation': 'Nova Scotia Health Authority'}}}}