Investigation of the Effect of Hyperbaric Oxygen Therapy in Patients With Avascular Necrosis

NCT07142018 | Active Not Recruiting

• 1 other identifier: Ismail Koc
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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. Hyperbaric oxygen therapy is a treatment method used in patients with avascular necrosis. Avascular 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.

Conditions

Avascular Necrosis of Femur Head

Outcome Measures

Primary Outcomes (3)

• tinetti performance oriented mobility assessment measure

  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.

  1 week

• Beck Depression Inventory

  It is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression.

  1 week

• Short form 36

  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.

  1 week

Study Arms (1)

Patients with Avascular Necrosis

Patients with Avascular Necrosis Undergone Hyperbaric Oxgen

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patient with Avascular Necrosis

You may qualify if:

• Be over 18 years of age,
• Receive hyperbaric treatment,
• Be diagnosed with avascular necrosis,
• Have stage 1-2 avascular necrosis according to the Ficat classification,
• Be able to understand and speak Turkish,
• Be able to read and write,

You may not qualify if:

• Having undergone orthopedic surgery on the lower extremities,
• Having cardio-respiratory failure that prevents walking,
• Having a disorder related to the musculoskeletal system other than AVN
• Having a diagnosis of avascular necrosis classified as stage 3-4 according to the Ficat classification
• Presence of varicose veins,
• Presence of urinary stress incontinence,
• Presence of systemic or rheumatological disease,
• Pregnancy,
• Refusal to participate in the study.

Sponsors & Collaborators

• Dr. Lutfi Kirdar Kartal Training and Research Hospital: lead

Study Sites (1)

Kartal Dr Lutfi Kirdar City Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Femur Head Necrosis

Condition Hierarchy (Ancestors)

Osteonecrosis; Bone Diseases; Musculoskeletal Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Prof

Study Record Dates

• First Submitted: August 19, 2025
• First Posted: August 26, 2025
• Study Start: August 19, 2025
• Primary Completion: August 25, 2025
• Study Completion: August 27, 2025
• Last Updated: August 26, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)