Avascular Necrosis of Femur HeadNCT07142018
Investigation of the Effect of Hyperbaric Oxygen Therapy in Patients With Avascular Necrosis
An observational study of Avascular Necrosis of Femur Head, run by Dr. Lutfi Kirdar Kartal Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Avascular Necrosis of Femur Head
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Aug 2025to 27 Aug 2025
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with Avascular Necrosis
Who may be able to join
- 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,
Who cannot join
- 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,
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- Presence of systemic or rheumatological disease,
- Pregnancy,
- Refusal to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Effect of Hyperbaric Oxygen Therapy on Physical Capacity, Depressive Symptoms, and Quality of Life in Patients With Avascular Necrosis
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.
Read the detailed description
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.
Hyperbaric 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.
Avascular 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.
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
- Medical subject headings
- Femur Head Necrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Avascular Necrosis | Patients with Avascular Necrosis Undergone Hyperbaric Oxgen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 week
Beck Depression Inventory
It is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression.
Measured: 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.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2025
- Study start19 Aug 2025
- Primary completion25 Aug 2025 (estimated)
- Study completion27 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Avascular Necrosis of Femur HeadStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Lutfi Kirdar Kartal Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, İsmail Koç, Dr. Lutfi Kirdar Kartal Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07142018
- Sponsor's protocol ID
- Ismail Koc
- Status last verified
- Aug 2025
- First submitted
- 19 Aug 2025
- Last updated
- 26 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No