Ignite Creation Date:
2025-12-24 @ 11:58 AM
Ignite Modification Date:
2026-01-01 @ 10:09 AM
Study NCT ID:
NCT04689061
Status:
UNKNOWN
Last Update Posted:
2022-02-16
First Post:
2020-12-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
FastThread Interference Screws
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070598', 'term': 'Anterior Cruciate Ligament Injuries'}], 'ancestors': [{'id': 'D007718', 'term': 'Knee Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'targetDuration': '12 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-08-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2023-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-02-15', 'studyFirstSubmitDate': '2020-12-23', 'studyFirstSubmitQcDate': '2020-12-28', 'lastUpdatePostDateStruct': {'date': '2022-02-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess change in Visual Analogue Scale (VAS)', 'timeFrame': 'preoperatively, 3 months, 6 months and 12 months post operative', 'description': 'Patient reported pain scale 0-10 point scale (0 min, 10 max)'}, {'measure': 'To assess change in Knee Injury and Osteoarthritis Outcome Score (KOOS)', 'timeFrame': 'preoperatively, 3 months, 6 months and 12 months post operative', 'description': 'Patient reported outcome assessment. The interval score ranges from 0 to 100, (where 0 represents total knee disability and 100 represents perfect knee health)'}, {'measure': 'To assess change in Range of Motion (ROM)', 'timeFrame': 'preoperatively, 3 months, 6 months and 12 months post operative', 'description': 'Measuring knee functionality. (Flexion 0 to 130 degrees Extension 120 to 0 degrees'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['ACL Injury']}, 'descriptionModule': {'briefSummary': 'Surgery using the Arthrex PEEK or Biocomposite FastThread Interference Screw for ACL or PCL (PCL at US sites only, Biocomposite screw PCL only) repair or reconstruction.', 'detailedDescription': 'The objective of the study is to evaluate the continued safety and effectiveness of the PEEK and Biocomposite FastThread Interference Screws used for Anterior Cruciate Ligament (ACL) and Posterior Cruciate Ligament (PCL) repair or reconstruction (PCL at US sites only, Biocomposite screw PCL only).\n\nTo assess safety, device-related adverse events will be reported and evaluated over the course of the study. To evaluate effectiveness, patient reported outcomes will be collected at 3 months postoperative, 6 months postoperative, and one year postoperative using the Visual Analogue Scale (VAS) for measuring pain in the affected knee and the Knee Injury and Osteoarthritis Outcome Score (KOOS) as well as Range of Motion (ROM, optional) for measuring knee functionality.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Approximately 50 subjects, male and female, at least 18 years of age, will be enrolled for the study. Subjects will be recruited from the surgeon's patient population or referrals from other physicians. The enrollment period is estimated to be 12 months.", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subject requires surgery using the Arthrex PEEK Interference Screw for ACL or PCL (PCL at US sites only) repair or reconstruction or the Arthrex Biocomposite Interference Screw for PCL (PCL at US sites only) repair or reconstruction.\n* Subject is 18 years of age or over.\n* Subject is not considered a vulnerable subject (i.e. child, pregnant, nursing, prisoner, or ward of the state).\n* Subject signed informed consent and is willing and able to comply with all study requirements.\n\nExclusion Criteria:\n\n* Current bilateral injury of the ACL or PCL.\n* Injury of the ACL and PCL in the same knee.\n* Insufficient quantity or quality of bone.\n* Blood supply limitations and previous infections which may retard healing.\n* Foreign-body sensitivity.\n* Any active infection or blood supply limitations.\n* Conditions that tend to limit the patient's ability or willingness to restrict activities or follow directions during the healing period.\n* Subjects that are skeletally immature."}, 'identificationModule': {'nctId': 'NCT04689061', 'briefTitle': 'FastThread Interference Screws', 'organization': {'class': 'INDUSTRY', 'fullName': 'Arthrex, Inc.'}, 'officialTitle': 'A Multi-Center, Prospective Study to Evaluate the Continued Safety and Effectiveness of the FastThread Interference Screws', 'orgStudyIdInfo': {'id': 'AIRR-0011'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Biocomposite FastThread Interference Screw', 'description': 'The absorbable Biocomposite Interference Screws combine the inherent degradation characteristics of a biocompatible polymer with the bioactivity of a ceramic. They are made of a combination of 70% poly (L-lactide-co-D, L-lactide) (PLDLA) and 30% biphasic calcium phosphate (BCP). The material has withstood the test of time with over a decade of clinical use and millions of implantations. It has been shown that the Biocomposite Interference Screw integrates well into the surrounding bone, produces little to no inflammatory response, and partially degrades 2 years after implantation', 'interventionNames': ['Device: Arthrex FastThread Interference Screw']}], 'interventions': [{'name': 'Arthrex FastThread Interference Screw', 'type': 'DEVICE', 'description': 'The Arthrex PEEK and Biocomposite FastThread Interference Screws have a tapered hexalobe design along the entire length of the screw to maximize transfer of torque and reduce screw stripping. The Arthrex PEEK and Biocomposite FastThread Interference Screws have a tapered hexalobe design along the entire length of the screw to maximize transfer of torque and reduce screw stripping', 'armGroupLabels': ['Biocomposite FastThread Interference Screw']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48025', 'city': 'Bingham Farms', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Samantha Martino', 'role': 'CONTACT', 'email': 'samantha.martino@arthrex.com', 'phone': '800-933-7001', 'phoneExt': '73506'}], 'facility': 'Anderson Sports Medicine', 'geoPoint': {'lat': 42.51587, 'lon': -83.27326}}, {'zip': '88214', 'city': 'Ravensburg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Sarah Villinger', 'role': 'CONTACT', 'email': 'sarah.villinger@arthrex.de', 'phone': '+49(89)9099005', 'phoneExt': '4231'}], 'facility': 'Sportklinik Ravensburg', 'geoPoint': {'lat': 47.78198, 'lon': 9.61062}}], 'centralContacts': [{'name': 'Samantha Martino', 'role': 'CONTACT', 'email': 'samantha.martino@arthrex.com', 'phone': '800.933.7001', 'phoneExt': '73506'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Arthrex, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Arthrex GmbH', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}