Ignite Creation Date:
2025-12-24 @ 9:15 PM
Ignite Modification Date:
2025-12-29 @ 9:22 PM
Study NCT ID:
NCT06262204
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-31
First Post:
2024-01-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hallux Valgus Correction Using the Metal Screw or the Human Allogeneic Cortical Bone Screw (Shark Screw).
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006215', 'term': 'Hallux Valgus'}], 'ancestors': [{'id': 'D005530', 'term': 'Foot Deformities'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'does get the information only after 2 years at the end of teh study'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-29', 'studyFirstSubmitDate': '2024-01-29', 'studyFirstSubmitQcDate': '2024-02-08', 'lastUpdatePostDateStruct': {'date': '2025-07-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'clinical result of Hallux Valgus treatment', 'timeFrame': '2 years', 'description': 'The primary objective of the study is the longitudinal evaluation of clinical outcomes (pain, appearance) over 2 years after hallux correction using a human, allogenic, bone screw or metal screw.'}], 'secondaryOutcomes': [{'measure': 'radiological (bony union)result of Hallux Valgus treatment', 'timeFrame': '1 years', 'description': 'The secondary aim of the study is the longitudinal evaluation of the radiological results over one year after hallux correction using a human, allogenic, bone screw or metal screw compared to pre-surgery values.'}, {'measure': 'change in forefoot-American Orthopaedic Foot and Ankle Society (AOFAS)', 'timeFrame': '2 years', 'description': 'The change in forefoot-AOFAS will be evaluated, between groups and in comparison to pre-surgery'}, {'measure': 'Hallux-Valgus angle (HVA) change', 'timeFrame': '2 years', 'description': 'Comparison of HVA pre-surgery and after 6, 12 and 24 months after surgery, between groups and in comparison to pre-surgery data'}, {'measure': 'gait analysis', 'timeFrame': '2 years', 'description': 'Number of patients with normal gait in the two groups and in comparison to a healthy cohort'}, {'measure': 'Intermetatarsal angle (IMA) change', 'timeFrame': '2 years', 'description': 'Comparison of IMA pre-surgery and after 6, 12 and 24 months after surgery, between groups and in comparison to pre-surgery data'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hallux Valgus', 'human allogeneic cortical bone screw', 'Shark Screw®', 'HVA', 'IMA', 'AOFAS', 'time to union', 'union rate', 'FFI'], 'conditions': ['Hallux Valgus']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to compare the treatment of Hallux Valgus using the conventional method (metal screw) with the new method (human allogeneic cortical bone screw (Shark Screw®) in adult patients with confirmed Hallux Valgus.\n\nThe main questions it aims to answer are:\n\nCan the new method obtain comparable results as the conventional method in regard to union rate and time to union? Are the number of complications lower with the new method? Participants will be operated either with the metal screw or with the Shark Screw®. The assignment to the groups is randomized.', 'detailedDescription': 'The planned prospective study will investigate whether the use of the human allogenic cortical bone screw (Shark Screw® leads to comparable results in the union rate and the prevention of recurrences as with metal screws. Furthermore, it will be investigated whether rotational stability is possible with the bone screw. The measurement of the HVA angle and the IMA angle should provide information on whether the correction is stable over time. A comparison of the AOFAS forefoot score before and after the operation for both methods is a further measure to check whether the human allogenic cortical bone screw can deliver similar results.\n\nInitial studies on the use of the allogenic bone screw in hand and foot surgery show particularly good integration behavior of the human allogenic cortical bone screw . A retrospective study by Hanslik-Schnabel et al has shown initial positive results in the treatment of hallux rigidus. In addition, a gait analysis is performed pre- and postoperatively to provide information on possible differences between the two groups in the context of 3D gait analysis/pedobarography and is also matched with another healthy cohort.\n\nAt the preoperative time point and after 12 and 24 months, a 3D gait analysis with a foot model is conducted to record the joint kinematics and kinetics. In the study by Canseco et al. , the proximal gait pattern changes remained unchanged. Hwang reported hyper-external rotation in the subtalar joint, excessive eversion in the subtalar joint, and lack of movement in the hallux MP joint in the terminal standing phase.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* between 18 and 85\n* confirmed Hallux Valgus\n\nExclusion Criteria:\n\n* \\<18 years and \\>85 years\n* Known underlying oncological disease\n* Pregnant women or breastfeeding mothers\n* Alcohol and drug abuse\n* Foreseeable compliance problems\n* Foreseeable loss of responsibility as a study doctor\n* Neoplastic diseases\n* Active osteomyelitis\n* Ulcerations in the area of the skin of the surgical site\n* Immunosuppressive medication that cannot be discontinued'}, 'identificationModule': {'nctId': 'NCT06262204', 'briefTitle': 'Hallux Valgus Correction Using the Metal Screw or the Human Allogeneic Cortical Bone Screw (Shark Screw).', 'organization': {'class': 'OTHER', 'fullName': 'Orthopedic Hospital Vienna Speising'}, 'officialTitle': 'Clinical and Radiological Comparison of Hallux Valgus Correction Using the Metal Screw or the Human Allogeneic Cortical Bone Screw, a Prospective Study', 'orgStudyIdInfo': {'id': 'Hallux Shark Screw(R)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'conventional group', 'description': 'standard surgery with metal screw', 'interventionNames': ['Procedure: Hallux Valgus Treatment with metal screw']}, {'type': 'EXPERIMENTAL', 'label': 'Shark Screw® group', 'description': 'new surgical procedure with human allogeneic cortical bone screw', 'interventionNames': ['Procedure: Hallux Valgus Treatment with Shark Screw®']}], 'interventions': [{'name': 'Hallux Valgus Treatment with Shark Screw®', 'type': 'PROCEDURE', 'description': 'This is a prospective, randomised study in which hallux valgus is corrected by means of a chevron/kin surgery technique using metal screws or human allogenic cortical bone screws (Shark Screw®, Surgebright, Lichtenberg, Austria). X-rays are taken before the operation at 6 weeks, three, six and twelve months after the operation. The X-ray images provide information on whether bony degeneration has taken place. In addition, the American Orthopaedic Foot \\& Ankle Society (AOFAS) hallux score, FFI score, hallux valgus angle (HVA) and intermetatarsal angle (IMA) are determined. These data are collected preoperatively and 4 weeks (HVA and IMA), six and twelve months postoperatively in order to rule out a change in the HVA and IMA and to document the changes in the AOFAS/FFI.', 'armGroupLabels': ['Shark Screw® group']}, {'name': 'Hallux Valgus Treatment with metal screw', 'type': 'PROCEDURE', 'description': 'This is a prospective, randomised study in which hallux valgus is corrected by means of a chevron/kin surgery technique using metal screws or human allogenic cortical bone screws (Shark Screw®, Surgebright, Lichtenberg, Austria). X-rays are taken before the operation at 6 weeks, three, six and twelve months after the operation. The X-ray images provide information on whether bony degeneration has taken place. In addition, the American Orthopaedic Foot \\& Ankle Society (AOFAS) hallux score, FFI score, hallux valgus angle (HVA) and intermetatarsal angle (IMA) are determined. These data are collected preoperatively and 4 weeks (HVA and IMA), six and twelve months postoperatively in order to rule out a change in the HVA and IMA and to document the changes in the AOFAS/FFI.', 'armGroupLabels': ['conventional group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1130', 'city': 'Vienna', 'country': 'Austria', 'contacts': [{'name': 'Florian Wenzel-Schwarz, MD', 'role': 'CONTACT', 'email': 'florian.wenzel-schwarz@oss.at', 'phone': '+43180182', 'phoneExt': '3081'}, {'name': 'Florian Wenzel-Schwarz, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Abteilung für Kinderorthopädie und Fußchirurgie Orthopädisches Spital Speising', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'centralContacts': [{'name': 'Florian Wenzel-Schwarz, MD', 'role': 'CONTACT', 'email': 'florian.wenzel@oss.at', 'phone': '+43180182', 'phoneExt': '3081'}, {'name': 'Andreas Kranzl, PhD', 'role': 'CONTACT', 'email': 'Andreas.Kranzl@oss.at'}], 'overallOfficials': [{'name': 'Florian Wenzel-Schwarz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Orthopädisches Spital Speising'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Due to sensitivity of Data'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Orthopedic Hospital Vienna Speising', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Forian Wenzel-Schwarz', 'investigatorAffiliation': 'Orthopedic Hospital Vienna Speising'}}}}