Ignite Creation Date:
2025-12-25 @ 12:18 AM
Ignite Modification Date:
2025-12-25 @ 10:21 PM
Study NCT ID:
NCT07014358
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-06-11
First Post:
2025-05-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Trial to Evaluate Three Systems of Osteosynthesis for Fixation of Olecranon Osteotomies in Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000092470', 'term': 'Olecranon Fracture'}], 'ancestors': [{'id': 'D000092482', 'term': 'Elbow Fractures'}, {'id': 'D000092464', 'term': 'Elbow Injuries'}, {'id': 'D001134', 'term': 'Arm Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D014458', 'term': 'Ulna Fractures'}, {'id': 'D005543', 'term': 'Forearm Injuries'}, {'id': 'D050723', 'term': 'Fractures, Bone'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 105}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-02', 'studyFirstSubmitDate': '2025-05-13', 'studyFirstSubmitQcDate': '2025-06-02', 'lastUpdatePostDateStruct': {'date': '2025-06-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Define which of the three fixarion systems is safer based on the number of patients with each fixation system that need to be reintervened.', 'timeFrame': '12 Months', 'description': 'The main evaluation criterion will be the need for reoperation for any cause related to the olecranon osteotomy in the first year of follow-up.'}], 'secondaryOutcomes': [{'measure': 'Number of patients suffering Adverse Events related or not with the medical product within a year', 'timeFrame': '12 months', 'description': 'Infection'}, {'measure': 'Number of patients suffering Adverse Events related or not with the medical product within a year', 'timeFrame': '12 months', 'description': 'Complications in the healing process of the surgical wound'}, {'measure': 'Number of patients suffering: Adverse Events related or not with the medical product within a year', 'timeFrame': '12 months', 'description': 'Mechanical complications with the implant'}, {'measure': 'Number of patients suffering Adverse Events related or not with the medical product, within a year', 'timeFrame': '12 months', 'description': 'Reintervention'}, {'measure': 'Number of patients suffering Adverse Events, related or not with the medical product, within a year', 'timeFrame': '12 months', 'description': 'Residual pain'}, {'measure': 'Number of patients suffering Adverse Events related or not, with the medical product, within a year', 'timeFrame': '12 months', 'description': 'Fracture'}, {'measure': 'Efficacy measured usimg the evaluation of different scales and tests performed by the patient, that altogether provide the needed information about the efficacy of the medical product.', 'timeFrame': '24 months', 'description': 'Measured by Pain leveld (BPI test)'}, {'measure': 'Efficacy, measured usimg the evaluation of different scales and tests performed by the patient that altogether provide the needed information about the efficacy of the medical product.', 'timeFrame': '24 months', 'description': 'Measured by Mayo Elbow Score Scale (MEPS)'}, {'measure': 'Efficacy, measured usimg the evaluation of different scales and tests performed by the patient, that altogether provide the needed information about the efficacy of the medical product', 'timeFrame': '24 months', 'description': 'Measured by pasive and active movility range'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Olecranon Fracture']}, 'descriptionModule': {'briefSummary': 'Surgery of the elbow joint is often made difficult by the highly constrained nature of the elbow joint. This is why it is often necessary to perform an osteotomy of the olecranon, the proximal part of the ulna, which allows perfect exposure of the entire articular surface. After performing the osteotomy, access to the joint is obtained, the articular problem is solved as appropriate and, upon completion, the osteotomized bone is fixed with a stable fixation system that allows the osteotomy to heal without problems. It is a safe, reproducible procedure that is associated with low associated morbidity. The main problems associated with this procedure are the lack of consolidation of the osteotomy or the need for removal of the osteosynthesis material at a later stage.', 'detailedDescription': 'The incidence of these complications is around 4% for the former and 20-50% for the latter. Both complications usually require a second surgical procedure to solve the problem, so the reoperation rates for these procedures are around 40-50%.\n\nHowever, there is discussion in the literature as to the most appropriate fixation system to ensure fracture healing. There are, broadly speaking, three frequently used fixation systems: the placement of two steel pins and a wire in an obenque configuration, the placement of a screwed plate or the placement of a compression screw.\n\nIt is not clear which is the best fixation system among these three. Biomechanical studies suggest that, from this point of view, all three procedures are adequate. The choice of which is ideal should therefore be based on the ease of use and the complications associated with the procedure, in particular the reoperation rate.There are no clinical trials in the literature comparing these three fixation techniques, so there is a clear lack of knowledge in this field.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who, after receiving information about the design, the purposes of the study, the possible risks that may arise from it and the fact that they may refuse to collaborate at any time, give their written consent to participate in the study.\n* Be over 18 years of ag\n* Have an elbow disorder that is to be treated surgically through an olecranon osteotomy approach.\n* That the olecranon osteotomy is amenable to synthesization with the three proposed systems.\n* Understand the purpose of the study and be available for routine hospital visits.\n\nExclusion Criteria:\n\n* Patients who have undergone ipsilateral elbow surgery.\n* Presence of ulnar fractures\n* Patients with an active infection at any site at the time of elbow surgery.\n* Inability to understand the procedure or information related to the study.'}, 'identificationModule': {'nctId': 'NCT07014358', 'briefTitle': 'Clinical Trial to Evaluate Three Systems of Osteosynthesis for Fixation of Olecranon Osteotomies in Adults', 'organization': {'class': 'OTHER', 'fullName': 'Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal'}, 'officialTitle': 'Randomized, Patient-blinded, Evaluator-blinded Clinical Trial With Three CE-marked and Approved Devices', 'orgStudyIdInfo': {'id': 'FIJAOLE01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fastening systems by placing two steel pins', 'description': 'Fixation of the osteotomized bone with a stable fixation system, in this case, the placement of two steel pins.', 'interventionNames': ['Device: Fastening systems by placing two steel pins']}, {'type': 'EXPERIMENTAL', 'label': 'Fastening systems by a wire in an obenque configuration', 'description': 'Fixation of the osteotomized bone with a stable fixation system, in this case, an obenque configuration.', 'interventionNames': ['Device: Fastening systems by a wire in an obenque configuration']}, {'type': 'EXPERIMENTAL', 'label': 'Fastening systems by the placement of a bolted plate or the placement of a compression screw', 'description': 'Fixation of the osteotomized bone with a stable fixation system, in this case, the placement of a bolted plate or the placement of a compression screw.', 'interventionNames': ['Device: Fastening systems by the placement of a bolted plate or the placement of a compression screw']}], 'interventions': [{'name': 'Fastening systems by placing two steel pins', 'type': 'DEVICE', 'description': 'Fixation of the osteotomized bone with a stable fixation system, in this case, the placement of two steel pins.', 'armGroupLabels': ['Fastening systems by placing two steel pins']}, {'name': 'Fastening systems by a wire in an obenque configuration', 'type': 'DEVICE', 'description': 'Fixation of the osteotomized bone with a stable fixation system, in this case, an obenque configuration', 'armGroupLabels': ['Fastening systems by a wire in an obenque configuration']}, {'name': 'Fastening systems by the placement of a bolted plate or the placement of a compression screw', 'type': 'DEVICE', 'description': 'Fixation of the osteotomized bone with a stable fixation system, in this case, the placement of a bolted plate or the placement of a compression screw.', 'armGroupLabels': ['Fastening systems by the placement of a bolted plate or the placement of a compression screw']}]}, 'contactsLocationsModule': {'locations': [{'zip': '39012', 'city': 'Santander', 'state': 'Cantabria', 'country': 'Spain', 'facility': 'Hospital Mutua Montañesa Santander', 'geoPoint': {'lat': 43.46589, 'lon': -3.80493}}, {'zip': '28035', 'city': 'Madrid', 'state': 'Madrid', 'country': 'Spain', 'contacts': [{'name': 'Ignacio De Rus Aznar', 'role': 'CONTACT', 'email': 'iderus@hotmail.com'}], 'facility': 'Clínica CEMTRO', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '46940', 'city': 'Valencia', 'state': 'Manises', 'country': 'Spain', 'contacts': [{'name': 'Pablo Cañete Pastor', 'role': 'CONTACT'}], 'facility': 'Hospital de Manises', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '46026', 'city': 'Valencia', 'state': 'Valencia', 'country': 'Spain', 'contacts': [{'name': 'Marta Navarro Bosch', 'role': 'CONTACT', 'email': 'mnavarrob26@yahoo.es'}], 'facility': 'Hospital La Fe', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '28935', 'city': 'Madrid', 'country': 'Spain', 'contacts': [{'name': 'Gia Rodríguez Vaquero', 'role': 'CONTACT', 'email': 'gia.rodriguez@quironsalud.es'}], 'facility': 'Hospital Universitario de Móstoles', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'centralContacts': [{'name': 'Miguel Ruiz Ibán, Md', 'role': 'CONTACT', 'email': 'drmri@hotmail.com', 'phone': '913368208'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}