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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Hyperbaric Oxygen Therapy on Physical Capacity, Depressive Symptoms, and Quality of Life in Patients With Avascular Necrosis
- ClinicalTrials.gov ID
- NCT07142018
- Acronym / sponsor ID
- Ismail Koc
- Conditions
- Avascular Necrosis of Femur Head
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Dr. Lutfi Kirdar Kartal Training and Research HospitalOther government
- Study start
- 19 Aug 2025 (actual)
- Primary completion
- 25 Aug 2025 (estimated)
- Study completion
- 27 Aug 2025 (estimated)
- First posted
- 26 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Avascular Necrosis | – | –Patients with Avascular Necrosis Undergone Hyperbaric Oxgen |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with Avascular Necrosis
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (9 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
tinetti performance oriented mobility assessment measure
Time frame: 1 week
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.
Beck Depression Inventory
Time frame: 1 week
It is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression.
Short form 36
Time frame: 1 week
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 26 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
tinetti performance oriented mobility assessment measure (time frame: 1 week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2025.