Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2025-12-25 @ 6:59 PM
Study NCT ID:
NCT05906004
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-09
First Post:
2023-05-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Post-Market Clinical Follow-up (PMCF) Study of the Pitch-Patch for the Augmentation or Reinforcement of the Rotator Cuff
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 32}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-11', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2029-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-04', 'studyFirstSubmitDate': '2023-05-25', 'studyFirstSubmitQcDate': '2023-06-07', 'lastUpdatePostDateStruct': {'date': '2025-07-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Constant Murley Score (CMS)', 'timeFrame': '2 years', 'description': 'The primary performance endpoint is the change in the CMS from baseline (if available) and between post-surgery timepoints up to at least 2 years after surgery.\n\nCMS comprises of 4 parts: Pain reported by the patient (max 15 points), activities of daily living reported by patient (max 20 points), range of movement assess by the examiner (max 40 points), and strength assessed by the examiner (max 25 points).\n\nScores range from 0 to 100. Better functioning shoulders will have a greater number of points, up to a maximum of 100 points.'}, {'measure': 'Device Related or Procedure Related Adverse Events', 'timeFrame': '2 years', 'description': 'Device related and/ or procedure related adverse events up to at least 2 years after surgery'}], 'secondaryOutcomes': [{'measure': 'Re-tear Rate', 'timeFrame': '2 years', 'description': 'Number of re-tear events as assessed by radiographical imaging (e.g., MRI, Ultrasound)'}, {'measure': 'Constant Murley Score (subscale)', 'timeFrame': '2 years', 'description': 'Change in CMS subscale scores (pain, activities of daily living, strength, and range of movement) from baseline and between post-surgery timepoints.\n\nCMS subscales: Pain reported by the patient (max 15 points), activities of daily living reported by patient (max 20 points), range of movement assess by the examiner (max 40 points), and strength assessed by the examiner (max 25 points).\n\nThe higher the score, the higher the shoulder function.'}, {'measure': 'Normal Daily Work/ Normal Recreational Activities', 'timeFrame': '2 years', 'description': 'Ability to perform normal daily work and normal recreational activities measured by CMS post-surgery.\n\nA subscale for Constant Murley Score, reported by the patient. Points range from 0-20, the higher the score, the higher the ability to perform normal daily work/ recreational activities.'}, {'measure': 'Tegner Score', 'timeFrame': '2 years', 'description': 'Change in Tegner Score from pre-injury and pre-surgery to post-surgery and between post-surgery timepoints.\n\nThe Tegner activity is a scale to identify graded level of activity of a patient. The scale ranges from 0 (very low level of activity) to 10 (extremely active). A score greater than 6 is only achievable with participation in sport.'}, {'measure': 'Subjective Shoulder Value', 'timeFrame': '2 years', 'description': 'Change in Subjective Shoulder Value (SSV) score from baseline and between post-surgery timepoints.\n\nSSV is measured on a percentage scale from 0% to 100%, with a higher percentage reflecting a subjective feel of a normal shoulder.'}, {'measure': 'Tissue Integration into the Pitch Patch', 'timeFrame': '2 years', 'description': "Tissue integration into the Pitch Patch will be assessed up to the 2 year time point and categorised into 'yes' or 'no' by the examiner. Tissue integration can be assessed from the following:\n\n* Radiological data\n* Histological data\n* Photographic data"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Rotator Cuff Reinforcement', 'Rotator Cuff Repair', 'Pitch-Patch', 'Xiros', 'Rotator Cuff Augmentation'], 'conditions': ['Rotator Cuff Tear', 'Rotator Cuff Tears', 'Rotator Cuff Tears of the Shoulder', 'Rotator Cuff Injuries']}, 'descriptionModule': {'briefSummary': "This is a clinical investigation study. It will verify the long-term safety and performance of the Pitch-Patch when implanted to reinforce partially repairable rotator cuff tears and used as described by the manufacturer's instructions.\n\nThe medical device in this study is already on the market and is manufactured by Xiros Ltd.\n\nThe Pitch-Patch is a single-use polyester prosthesis available in two sizes (30x20mm and 35x25mm). It is reinforced around the perimeter and around each eyelet to provide strength and stability to the device and repair.\n\nThe study will collect data on patients who meet the entry criteria and have received the device.\n\nThis is a single-armed study, meaning all patients will have a Pitch-Patch. The total length of the is expected to be 4 years; this includes a recruitment period of 2 years, and a follow-up period (for the prospective clinical investigation) of 2 years.\n\nA minimum of 32 patients will be enrolled into the study. Follow-up data will be collected at (if available for retrospective data) 3 months, 6 months, 1 year, 2 years and final follow-up (maximum 2.5 years for prospective study; maximum of 5 years for retrospective study).", 'detailedDescription': "This is a clinical investigation study with both a prospective and retrospective study design. It will verify the long-term safety and performance of the Pitch-Patch when implanted to reinforce partially repairable rotator cuff tears and used as described by the manufacturer's instructions.\n\nThe medical device in this study is already on the market and is manufactured by Xiros Ltd.\n\nThe Pitch-Patch is a single-use polyester prosthesis available in two sizes (30x20mm and 35x25mm). It is reinforced around the perimeter and around each eyelet to provide strength and stability to the device and repair.\n\nThe study will collect data on patients who meet the entry criteria and have received the device.\n\nThis is a single-armed study, meaning all patients will have a Pitch-Patch. The total length of the is expected to be 4 years; this includes a recruitment period of 2 years, and a follow-up period (for the prospective clinical investigation) of 2 years.\n\nA minimum of 32 patients will be enrolled into the study. Follow-up data will be collected at (if available for retrospective data) 3 months, 6 months, 1 year, 2 years and final follow-up (maximum 2.5 years for prospective study; maximum of 5 years for retrospective study)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Rotator cuff tear treated with Pitch-Patch for augmentation or reinforcement of the rotator cuff.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Treated using Pitch-Patch device for augmentation or reinforcement of the rotator cuff since 2012.\n* If applicable, patient is willing to participate in the study (beyond standard of (routine) care) and have been informed of the nature of the study, agree to its follow-up and have provided written informed consent as approved by the Ethics Committee (EC).\n\nExclusion Criteria:\n\n* There are no exclusion criteria; the aim of this study is to collect all data to see how the device is used in the real world setting.'}, 'identificationModule': {'nctId': 'NCT05906004', 'briefTitle': 'Post-Market Clinical Follow-up (PMCF) Study of the Pitch-Patch for the Augmentation or Reinforcement of the Rotator Cuff', 'organization': {'class': 'INDUSTRY', 'fullName': 'Xiros Ltd'}, 'officialTitle': 'Post-Market Clinical Follow-up (PMCF) Study of the Pitch-Patch for the Augmentation or Reinforcement of the Rotator Cuff', 'orgStudyIdInfo': {'id': 'CRE 031'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Pitch-Patch', 'type': 'DEVICE', 'description': 'Pitch-Patch device used for rotator cuff augmentation/ reinforcement.'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Lisa Cook', 'role': 'CONTACT', 'email': 'lisa.cook@xiros.co.uk', 'phone': '+44 (0) 113 238 7200'}, {'name': 'Vikki Adams', 'role': 'CONTACT', 'email': 'vikki.adams@xiros.co.uk', 'phone': '07825626018'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xiros Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}