Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2026-02-23 @ 8:31 PM
Study NCT ID:
NCT04109469
Status:
COMPLETED
Last Update Posted:
2019-09-30
First Post:
2019-09-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Shark Screw® - Hand- and Foot Surgery Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000844', 'term': 'Ankylosis'}], 'ancestors': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2019-02-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-27', 'studyFirstSubmitDate': '2019-09-27', 'studyFirstSubmitQcDate': '2019-09-27', 'lastUpdatePostDateStruct': {'date': '2019-09-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Osseous consolidation of the transplant', 'timeFrame': '1 year', 'description': 'Absence of radiolucent lines around the transplant in the x-ray'}, {'measure': 'Evaluation pre- and postoperative pain (VAS)', 'timeFrame': '1 year', 'description': 'The visual analogue scale (VAS) is a vertical line, 10 centimeters (100 mm) in length, anchored by 2 verbal descriptors, one for each symptom extremes (0mm = no pain - 100mm = worst imaginable pain). A higher score indicates more pain.'}], 'secondaryOutcomes': [{'measure': 'Incidence of postoperative complication and soft tissue irritation', 'timeFrame': '1 year', 'description': 'Did wound healing disorder or soft tissue irritation occur?'}, {'measure': 'Incidence of surgical revision', 'timeFrame': '1 year', 'description': 'Was a surgical revision done postoperatively?'}, {'measure': 'Incidence of postoperative pseudarthrosis', 'timeFrame': '1 year', 'description': 'Based on x-rays or MRI: Is a postoperative pseudarthrosis visible?'}, {'measure': 'Duration of post-operative analgesic medication', 'timeFrame': '1 year', 'description': 'How long did the patient take analgesics after surgery?'}, {'measure': 'Cellular contact to the recipient bone', 'timeFrame': '1 year', 'description': 'Absence of sclerosis around the transplant in the x-ray'}, {'measure': 'Resorptive processes in the recipient bone', 'timeFrame': '1 year', 'description': 'Absence of cystic lucency in the x-ray'}, {'measure': 'Incidence of cracking or loosening of the screw', 'timeFrame': '1 year', 'description': 'Based on x-rays: Is a loosening or cracking of the screw visible?'}, {'measure': 'Patient satisfaction', 'timeFrame': '1 year', 'description': 'Patient satisfaction was classified as "very satisfied", "satisfied" and "not satisfied"'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Arthrodesis', 'Osteotomy']}, 'descriptionModule': {'briefSummary': 'This observational study aims to determine the efficacy and safety of the Shark Screw® transplant for osteotomy and arthrodesis in hand and foot surgery.', 'detailedDescription': 'The Shark Screw® transplant (surgebright GmbH) is a human cortical bone allograft for osteosynthesis and can replace metal or bioabsorbable devices in various procedures. In total, the clinical records from 32 patients who had undergone surgical procedure at the hand or foot between October 2016 and January 2018 with the use of a Shark Screw® transplant for joint arthrodesis or for the stabilization of osteotomies serve as data sources for this study. The aim of this study is to evaluate the efficacy and safety of the Shark Screw® transplant in hand and foot surgery by analyzing the recovery, wound and bone healing process.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients who underwent hand- or foot surgery with the application of a Shark Screw® transplant', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Application of the human bone graft Shark Screw® in a Hand- or Foot surgical procedure between October 2016 and January 2018\n* Data from at least 1 follow-up examination after surgery around the 6th post-operative week or other information about the health status of the patient in the first 6 post-operative weeks\n\nExclusion Criteria:\n\n* not enough data for an objective analysis'}, 'identificationModule': {'nctId': 'NCT04109469', 'briefTitle': 'Shark Screw® - Hand- and Foot Surgery Study', 'organization': {'class': 'OTHER', 'fullName': 'Klinik Diakonissen Linz GmbH'}, 'officialTitle': 'Retrospective Study on the Use of a Human Bone Graft (Shark Screw®) in Hand- and Foot Surgery', 'orgStudyIdInfo': {'id': '1099/2018'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Shark Screw® transplant', 'type': 'DEVICE', 'description': 'Application of a Shark Screw® transplant for osteosynthesis or arthrodesis in hand- or foot surgery'}]}, 'contactsLocationsModule': {'locations': [{'zip': '4020', 'city': 'Linz', 'country': 'Austria', 'facility': 'Klinik Diakonissen Linz GmbH', 'geoPoint': {'lat': 48.30639, 'lon': 14.28611}}], 'overallOfficials': [{'name': 'Klaus Pastl, Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Klinik Diakonissen Linz'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Klinik Diakonissen Linz GmbH', 'class': 'OTHER'}, 'collaborators': [{'name': 'Surgebright Gmbh', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}