Ignite Creation Date:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2025-12-26 @ 2:22 AM
Study NCT ID:
NCT06076902
Status:
RECRUITING
Last Update Posted:
2023-10-11
First Post:
2023-09-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Patch Study (Patch-augmented Rotator Cuff Repair)
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Single blind study in which only patients will not be aware of treatment (with or without rotator cuff augmentation with polyester patch)'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-04-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2027-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-04', 'studyFirstSubmitDate': '2023-09-18', 'studyFirstSubmitQcDate': '2023-10-04', 'lastUpdatePostDateStruct': {'date': '2023-10-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rotator cuff retear rate', 'timeFrame': 'Up to two years postoperative', 'description': 'Occurence of retear following rotator cuff reconstruction to treat massive tear (measured using radiological imaging/ultrasound)'}], 'secondaryOutcomes': [{'measure': 'Complication rate (adverse event greater than grade 2)', 'timeFrame': 'Up to two years postoperative', 'description': 'Development of postoperative complications following rotator cuff reconstruction to treat massive tear'}, {'measure': 'Pain levels', 'timeFrame': 'Preoperative and postoperative (6 weeks, 3 months, 1- and 2-year follow-up visits)', 'description': 'During clinical assessments, patient reported pain levels will be measured using visual analogue scale (VAS); scale 0 (low) to 15 (high)'}, {'measure': 'Healing rate', 'timeFrame': '6-week and 1-year exams (postoperative)', 'description': 'Using radiological imaging (ultrasound), healing of the rotator cuff tear will be monitored over time'}, {'measure': 'Range of motion', 'timeFrame': 'Preoperative and postoperative (6 weeks, 3 months, 1- and 2-year follow-up visits)', 'description': 'Clinical assessments of healing using the range of motion will be compared over time'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Rotator Cuff Repair'], 'conditions': ['Rotator Cuff Tears']}, 'descriptionModule': {'briefSummary': 'This single-center, prospective, randomized controlled study will compare patients allocated to two treatment arms who are undergoing surgery to repair rotator cuff tears: (1) arthroscopic rotator cuff reconstruction using fixation with anchors augmented with a synthetic polyester patch, and (2) arthroscopic rotator cuff reconstruction using fixation with anchors and no augmentation with a synthetic polyester patch. The primary objective is to compare complications (primarily retear rates) and the secondary objective is to compare mid- and long-term clinical and radiological outcomes using standard orthopedic assessments, such as the subjective shoulder value and the Constant-Murley score.', 'detailedDescription': 'This single-center, prospective, randomized controlled study will compare patients allocated to two treatment arms who are undergoing surgery to repair rotator cuff tears: (1) arthroscopic rotator cuff reconstruction using fixation with anchors augmented with a synthetic polyester patch, and (2) arthroscopic rotator cuff reconstruction using fixation with anchors and no augmentation with a synthetic polyester patch. The primary objective is to compare complications (primarily retear rates) and the secondary objective is to compare mid- and long-term clinical and radiological outcomes using standard orthopedic assessments, such as the subjective shoulder value and the Constant-Murley score.\n\nThe Pitch-Patch is a single-use synthetic polyester patch (Pitch-Patch, neoligamentsTM, Leeds, UK) intended to reinforce the rotator cuff following or during repair by sutures or suture anchors where weakness exists in the soft tissue. The surgical group will be randomly assigned, and each group will include 150 patients. After surgery, patients will be followed for two years and undergo clinical and radiological assessments.\n\nThe main research question to be answered by this investigation is whether synthetic patch augmentation can significantly improve outcomes in patients with rotator cuff tears from either degenerative or traumatic origins versus patients with no patch augmentation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults with massive rotator cuff tear\n* Tear must affect at least two tendons\n* Primary surgery only\n* Origin of tear can be either degenerative or traumatic\n* German language speaking\n\nExclusion Criteria:\n\n* Fatty infiltration grade 4 (according to Goutallier)\n* Bilateral tears\n* Cases of arthritis or severe osteoarthritis\n* Structural or pathological condition of the bone or soft tissue that could impair healing\n* Unable or unwilling to restrict activities to prescribed levels or follow rehabilitation guidelines\n* Unable or unwilling to give consent (language barrier or cognitive impairment)\n* Unwilling or unable to be assessed at 1- and 2-year follow-up assessment visits'}, 'identificationModule': {'nctId': 'NCT06076902', 'briefTitle': 'Patch Study (Patch-augmented Rotator Cuff Repair)', 'organization': {'class': 'OTHER', 'fullName': 'Spital Thurgau AG'}, 'officialTitle': 'Patch Study: a Single-center, Prospective, Single-blind, Randomized, Two-arm Controlled Study of Outcomes Following Synthetic Polyester Patch-augmented Rotator Cuff Repair', 'orgStudyIdInfo': {'id': 'ProjectID 2023-00238'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment group with patch augmentation', 'description': 'Arthroscopic rotator cuff reconstruction using fixation with anchors augmented with a synthetic polyester patch', 'interventionNames': ['Device: Arthroscopic rotator cuff reconstruction using fixation with anchors augmented with a synthetic polyester patch (Pitch-Patch Tissue Reinforcement Device))']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Comparison group without patch augmentation', 'description': 'Arthroscopic rotator cuff reconstruction using fixation with anchors and no augmentation with a synthetic polyester patch', 'interventionNames': ['Device: Arthroscopic rotator cuff reconstruction using fixation with anchors augmented without a synthetic polyester patch']}], 'interventions': [{'name': 'Arthroscopic rotator cuff reconstruction using fixation with anchors augmented with a synthetic polyester patch (Pitch-Patch Tissue Reinforcement Device))', 'type': 'DEVICE', 'otherNames': ['Pitch-Patch Tissue Reinforcement Device (version model number 102-1090)'], 'description': 'The Pitch-Patch is a single-use device intended to reinforce the rotator cuff following or during repair by sutures or suture anchors where weakness exists in the soft tissue.', 'armGroupLabels': ['Treatment group with patch augmentation']}, {'name': 'Arthroscopic rotator cuff reconstruction using fixation with anchors augmented without a synthetic polyester patch', 'type': 'DEVICE', 'description': 'Arthroscopic rotator cuff reconstruction using fixation with anchors and no augmentation with a synthetic polyester patch.', 'armGroupLabels': ['Comparison group without patch augmentation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8501', 'city': 'Frauenfeld', 'state': 'Thurgau', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Florian Hess, MD', 'role': 'CONTACT', 'email': 'florian.hess@stgag.ch', 'phone': '+41 58 144 8143'}], 'facility': 'Spital Thurgau AG', 'geoPoint': {'lat': 47.55776, 'lon': 8.89893}}], 'centralContacts': [{'name': 'Florian Hess, MD', 'role': 'CONTACT', 'email': 'florian.hess@stgag.ch', 'phone': '+41 58 144 8143'}], 'overallOfficials': [{'name': 'Florian Hess, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Spital Thurgau AG'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Spital Thurgau AG', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}