Ignite Creation Date:
2025-12-25 @ 4:51 AM
Ignite Modification Date:
2025-12-26 @ 3:52 AM
Study NCT ID:
NCT07142018
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-26
First Post:
2025-08-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Investigation of the Effect of Hyperbaric Oxygen Therapy in Patients With Avascular Necrosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005271', 'term': 'Femur Head Necrosis'}], 'ancestors': [{'id': 'D010020', 'term': 'Osteonecrosis'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-08-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-08-27', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-19', 'studyFirstSubmitDate': '2025-08-19', 'studyFirstSubmitQcDate': '2025-08-19', 'lastUpdatePostDateStruct': {'date': '2025-08-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-08-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'tinetti performance oriented mobility assessment measure', 'timeFrame': '1 week', 'description': 'The Tinetti assessment tool is an easily administered task-oriented test that measures an older adult\'s gait and balance abilities. Scoring: A three-point ordinal scale, ranging from 0-2. "0" indicates the highest level of impairment and "2" the individuals independence.'}, {'measure': 'Beck Depression Inventory', 'timeFrame': '1 week', 'description': 'It is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression.'}, {'measure': 'Short form 36', 'timeFrame': '1 week', 'description': 'SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. These measures rely upon patient self-reporting and have been widely used.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Avascular Necrosis of Femur Head']}, 'descriptionModule': {'briefSummary': 'Avascular necrosis is a condition that occurs when bone tissue loses sufficient blood flow. This condition causes bone cells to die and, as a result, bone structure to deteriorate.\n\nHyperbaric oxygen therapy is a treatment method used in patients with avascular necrosis.\n\nAvascular necrosis can significantly affect the quality of life of patients. The aim of this study was to investigate the effects of hyperbaric oxygen therapy on physical capacity, depressive symptoms, and quality of life in patients diagnosed with avascular necrosis.', 'detailedDescription': 'Avascular necrosis is a condition that occurs when bone tissue loses sufficient blood flow. This condition causes bone cells to die and, as a result, bone structure to deteriorate. It is commonly seen in joints such as the hip, knee, ankle, and shoulder.\n\nHyperbaric oxygen therapy is a treatment method used in patients with avascular necrosis. In hyperbaric oxygen therapy, patients breathe 100% oxygen under high pressure. This treatment can help treat avascular necrosis by increasing oxygen, promoting new blood vessel formation, reducing inflammation, and facilitating cell repair mechanisms.\n\nAvascular necrosis can significantly affect the quality of life of patients. The effects of avascular necrosis on quality of life can be summarized as follows: Avascular necrosis often causes severe pain and limited mobility in the joint areas. These physical symptoms can prevent patients from performing their daily activities, leading to social isolation and a decline in overall quality of life.\n\nThe aim of this study was to investigate the effects of hyperbaric oxygen therapy on physical capacity, depressive symptoms, and quality of life in patients diagnosed with avascular necrosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patient with Avascular Necrosis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Be over 18 years of age,\n* Receive hyperbaric treatment,\n* Be diagnosed with avascular necrosis,\n* Have stage 1-2 avascular necrosis according to the Ficat classification,\n* Be able to understand and speak Turkish,\n* Be able to read and write,\n\nExclusion Criteria:\n\n* Having undergone orthopedic surgery on the lower extremities,\n* Having cardio-respiratory failure that prevents walking,\n* Having a disorder related to the musculoskeletal system other than AVN\n* Having a diagnosis of avascular necrosis classified as stage 3-4 according to the Ficat classification\n* Presence of varicose veins,\n* Presence of urinary stress incontinence,\n* Presence of systemic or rheumatological disease,\n* Pregnancy,\n* Refusal to participate in the study.'}, 'identificationModule': {'nctId': 'NCT07142018', 'briefTitle': 'Investigation of the Effect of Hyperbaric Oxygen Therapy in Patients With Avascular Necrosis', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Dr. Lutfi Kirdar Kartal Training and Research Hospital'}, 'officialTitle': 'Investigation of the Effect of Hyperbaric Oxygen Therapy on Physical Capacity, Depressive Symptoms, and Quality of Life in Patients With Avascular Necrosis', 'orgStudyIdInfo': {'id': 'Ismail Koc'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with Avascular Necrosis', 'description': 'Patients with Avascular Necrosis Undergone Hyperbaric Oxgen'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Kartal Dr Lutfi Kirdar City Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dr. Lutfi Kirdar Kartal Training and Research Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Prof', 'investigatorFullName': 'İsmail Koç', 'investigatorAffiliation': 'Dr. Lutfi Kirdar Kartal Training and Research Hospital'}}}}