Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 7:39 PM
Study NCT ID:
NCT07400692
Status:
RECRUITING
Last Update Posted:
2026-02-10
First Post:
2026-02-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
This is a Study to Find Out Whether Surgery Using a Metal Plate to Fix a Broken Elbow in Older Adults Leads to Better Recovery and Arm Function Compared to Non-surgical Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000070799', 'term': 'Open Fracture Reduction'}, {'id': 'D000072700', 'term': 'Conservative Treatment'}], 'ancestors': [{'id': 'D005592', 'term': 'Fracture Fixation'}, {'id': 'D019637', 'term': 'Orthopedic Procedures'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 84}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-02-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2030-02-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-03', 'studyFirstSubmitDate': '2026-02-03', 'studyFirstSubmitQcDate': '2026-02-03', 'lastUpdatePostDateStruct': {'date': '2026-02-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-02-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'between-group difference in the Oxford Elbow Score (Italian Version) with the subscales Function, Pain, and Social-Psychological', 'timeFrame': '6 months after injury', 'description': 'the Oxford Elbow Score is a patient-reported outcome measure specifically developed to evaluate elbow function. It includes 12 items divided into three domains: elbow pain, elbow function, and social-psychological impact. Each item is scored on a 5-point scale, and domain scores can be summed to obtain an overall score, where higher values indicate better outcomes. It is validated for use in both clinical and research settings and is sensitive to change, making it suitable for assessing treatment effects in patients with elbow disorders'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Olecranon Fracture']}, 'descriptionModule': {'briefSummary': "This study takes place in one hospital and uses a random method to divide patients into groups. It looks at the best way to treat a broken elbow (specifically, a displaced olecranon fracture) in older adults who don't use their arms heavily. There are 84 patients in total, with 42 people in each group"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Patients with an acute (\\< 2 weeks) Mayo type 2A or 2B olecranon fracture\n* Patients aged \\> 65 years • Patients with reduced functional demand, with a score \\> 2 and \\< 7 on the Clinical Frailty Scale\n* Patients able to provide informed consent and follow all study procedures as indicated in the protocol\n* Signed informed consent for study participation\n\nExclusion criteria:\n\n* Patients aged \\< 65 years or with a Clinical Frailty Scale score \\> 7 or \\< 2\n* Patients with a Mayo type 2A or 2B fracture seen more than 2 weeks after injury\n* Old fracture (\\> 6 months), pseudoarthrosis, or unhealed nerve injury of the ipsilateral upper limb\n* Open (Gustilo-Anderson type 2 or 3) or pathological fracture\n* Previous injury to, or other condition of, the elbow with severe functional impairment\n* Patients with severe comorbidities preventing safe surgical treatment\n* Other acute fracture or nerve damage of the ipsilateral upper limb\n* Known drug or alcohol abuse\n* Inability to follow study procedures (e.g., due to language barriers or severe comorbidities)'}, 'identificationModule': {'nctId': 'NCT07400692', 'briefTitle': 'This is a Study to Find Out Whether Surgery Using a Metal Plate to Fix a Broken Elbow in Older Adults Leads to Better Recovery and Arm Function Compared to Non-surgical Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Ente Ospedaliero Cantonale, Bellinzona'}, 'officialTitle': 'Treatment of Olecranon Fractures in the Elderly, a Randomised Controlled Trial Comparing Surgical and Conservative Treatment', 'orgStudyIdInfo': {'id': 'ORL-ORT-049'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'surgery', 'description': 'Open reduction and plate osteosynthesis. The surgical treatment will be performed with a direct approach to the olecranon using a locking compression plate.', 'interventionNames': ['Procedure: Open reduction and plate osteosynthesis']}, {'type': 'OTHER', 'label': 'rehabilitation', 'description': 'Standard rehabilitation with optional upper arm sling for comfort for 2 weeks and progressive mobilization protocol', 'interventionNames': ['Other: Conservative treatment with early mobilisation']}], 'interventions': [{'name': 'Open reduction and plate osteosynthesis', 'type': 'PROCEDURE', 'description': 'A cut is made along the back of the elbow to reach the broken bone. The surgeon carefully moves tissues aside and protects nearby nerves.\n\nThe broken bone is cleaned, realigned, and held in place with a special metal plate and screws. This helps support the bone, especially in older patients with fragile bones. The surgeon checks the placement using live X-ray and moves the arm to ensure stability.\n\nThe area is then closed with stitches, bandaged, and sometimes supported with a light splint. Recovery starts early, with gentle exercises to regain movement while protecting the repair.', 'armGroupLabels': ['surgery']}, {'name': 'Conservative treatment with early mobilisation', 'type': 'OTHER', 'description': 'Conservativel treatment usually involves wearing a sling or light support for about two weeks to manage pain. After that, the patient begins gentle, supervised arm movements to prevent stiffness and muscle loss. As the pain improves, exercises become more active and focused on regaining strength. The goal is to let the bone heal while keeping the elbow working well.', 'armGroupLabels': ['rehabilitation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6900', 'city': 'Lugano', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Christian Candrian, Prof.Dr.med', 'role': 'CONTACT', 'email': 'christian.candrian@eoc.ch', 'phone': '+41 (0) 91 811 61 23'}], 'facility': 'EOC - Orthopaedics and Traumatology Service', 'geoPoint': {'lat': 46.01008, 'lon': 8.96004}}], 'centralContacts': [{'name': 'Davide Previtali, MD', 'role': 'CONTACT', 'email': 'RicercaOrtopedia.ORL@eoc.ch', 'phone': '0041918117029'}], 'overallOfficials': [{'name': 'Davide Previtali, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'EOC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ente Ospedaliero Cantonale, Bellinzona', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}