Osteonecrosis of the Femoral HeadTM-ONFHNCT07560163
Triple-Modal Therapy in Early-Stage Femoral Head Osteonecrosis (TM-ONFH)
An observational study of Osteonecrosis of the Femoral Head, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
This retrospective observational study evaluates the clinical and radiological outcomes of patients with early-stage osteonecrosis of the femoral head treated with a combination of core decompression, stromal vascular fraction (SVF), and hyperbaric oxygen therapy (HBOT). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Osteonecrosis of the Femoral Head
- What is being tested?
- Core decompression, stromal vascular fraction (SVF) and Hyperbaric Oxygen Therapy (HBOT)
- Type of treatment
- Surgery or procedure
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Jan 2025to 22 Nov 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Patients with early-stage osteonecrosis of the femoral head treated with triple-modal therapy at a single center.
Who may be able to join
- Patients diagnosed with Ficat-Arlet Stage II osteonecrosis of the femoral head
- Patients treated with combined core decompression, stromal vascular fraction (SVF), and hyperbaric oxygen therapy (HBOT)
- Age between 18 and 65 years
- Patients who completed all components of the treatment protocol
- Minimum follow-up duration of 24 months
Who cannot join
- Patients with advanced-stage osteonecrosis (Ficat-Arlet Stage III-IV)
- Patients with a history of previous hip surgery
- Patients who previously received hyperbaric oxygen therapy for ONFH
- Patients who received prior cellular therapies (e.g., stem cell therapy or PRP) in the hip joint
- Patients with incomplete medical records
- Patients who did not complete the full treatment protocol
- Patients with follow-up duration less than 24 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Triple-Modal Therapy (Core Decompression, Stromal Vascular Fraction, and Hyperbaric Oxygen Therapy) is Associated Improved Clinical and Radiologic Outcomes in Early-Stage Osteonecrosis of the Femoral Head: Two-Year Follow-Up of 24 Patients
This retrospective observational study evaluates the clinical and radiological outcomes of patients with early-stage osteonecrosis of the femoral head treated with a combination of core decompression, stromal vascular fraction (SVF), and hyperbaric oxygen therapy (HBOT). A total of 24 patients were included and followed for two years. The aim of this study is to assess the effectiveness of this combined therapeutic approach in improving clinical outcomes and preventing disease progression.
Read the detailed description
Osteonecrosis of the femoral head (ONFH) is a progressive disease that can lead to femoral head collapse and the need for total hip arthroplasty. Joint-preserving treatments are particularly important in early-stage disease. Core decompression is a widely used technique to reduce intraosseous pressure and improve blood flow. Stromal vascular fraction (SVF), which contains mesenchymal stem cells, may enhance bone regeneration. Hyperbaric oxygen therapy (HBOT) has been shown to improve tissue oxygenation and promote healing.
In this study, patients with early-stage ONFH who underwent a combined treatment of core decompression, SVF injection, and HBOT were retrospectively analyzed. Clinical outcomes were assessed using functional scores, and radiological progression was evaluated during a two-year follow-up period. The purpose of this study is to determine whether this triple-modal therapy provides improved outcomes compared to conventional treatment approaches.
- Conditions
- Osteonecrosis of the Femoral Head
- Being tested
- Core decompression, stromal vascular fraction (SVF), Hyperbaric Oxygen Therapy (HBOT)
- Keywords
- Core Decompression, Stromal Vascular Fraction, Hyperbaric Oxygen Therapy, Hip Osteonecrosis
- Medical subject headings
- Legg-Calve-Perthes Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Core decompressionProcedure or surgery
Surgical procedure performed to reduce intraosseous pressure and improve blood flow in the femoral head.
stromal vascular fraction (SVF)Biological
Autologous stromal vascular fraction containing mesenchymal stem cells applied to enhance bone regeneration.
Hyperbaric Oxygen Therapy (HBOT)Other
Adjunctive hyperbaric oxygen therapy used to improve tissue oxygenation and promote healing.
| Study group | Role | What they receive |
|---|---|---|
| Triple-Modal Therapy Group | Patients with early-stage osteonecrosis of the femoral head treated with a combination of core decompression, stromal vascular fraction (SVF), and hyperbaric oxygen therapy (HBOT). Receives: Procedure: Core decompression; Biological: stromal vascular fraction (SVF); Other: Hyperbaric Oxygen Therapy (HBOT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Modified Harris Hip Score (MHHS)
Assessment of clinical improvement using the Modifed Harris Hip Score in patients treated with triple-modal therapy.
Measured: Baseline to 24 months
Secondary outcomes (2)
Radiological progression of osteonecrosis
Evaluation of disease progression using radiographic imaging.
Measured: Baseline to 24 months
Conversion to total hip arthroplasty (THA)
Number of patients requiring total hip arthroplasty during follow-up.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2026
- Study start22 Jan 2025
- Primary completion22 Sep 2025
- Study completion22 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteonecrosis of the Femoral HeadStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İbrahim Alper YAVUZ, Ankara City Hospital Bilkent
- Investigators
- ibrahim alper yavuz, MD, PhD, Study chair, Ankara Bilkent City Hospital, Department of Orthopedics and Traumatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07560163
- Sponsor's protocol ID
- TABED 2-25-843
- Acronym
- TM-ONFH
- Status last verified
- Apr 2026
- First submitted
- 24 Apr 2026
- Last updated
- 6 May 2026
- 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 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Triple-Modal Therapy (Core Decompression, Stromal Vascular Fraction, and Hyperbaric Oxygen Therapy) is Associated Improved Clinical and Radiologic Outcomes in Early-Stage Osteonecrosis of the Femoral Head: Two-Year Follow-Up of 24 Patients
- ClinicalTrials.gov ID
- NCT07560163
- Acronym / sponsor ID
- TM-ONFH / TABED 2-25-843
- Conditions
- Osteonecrosis of the Femoral Head
- Keywords
- Core Decompression, Stromal Vascular Fraction, Hyperbaric Oxygen Therapy, Hip Osteonecrosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 22 Jan 2025 (actual)
- Primary completion
- 22 Sep 2025 (actual)
- Study completion
- 22 Nov 2025 (actual)
- First posted
- 30 Apr 2026 (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.
This retrospective observational study evaluates the clinical and radiological outcomes of patients with early-stage osteonecrosis of the femoral head treated with a combination of core decompression, stromal vascular fraction (SVF), and hyperbaric oxygen therapy (HBOT). A total of 24 patients were included and followed for two years. The aim of this study is to assess the effectiveness of this combined therapeutic approach in improving clinical outcomes and preventing disease progression.
Detailed description
Osteonecrosis of the femoral head (ONFH) is a progressive disease that can lead to femoral head collapse and the need for total hip arthroplasty. Joint-preserving treatments are particularly important in early-stage disease. Core decompression is a widely used technique to reduce intraosseous pressure and improve blood flow. Stromal vascular fraction (SVF), which contains mesenchymal stem cells, may enhance bone regeneration. Hyperbaric oxygen therapy (HBOT) has been shown to improve tissue oxygenation and promote healing.
In this study, patients with early-stage ONFH who underwent a combined treatment of core decompression, SVF injection, and HBOT were retrospectively analyzed. Clinical outcomes were assessed using functional scores, and radiological progression was evaluated during a two-year follow-up period. The purpose of this study is to determine whether this triple-modal therapy provides improved outcomes compared to conventional treatment approaches.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Triple-Modal Therapy Group | – | Procedure: Core decompression, Biological: stromal vascular fraction (SVF), Other: Hyperbaric Oxygen Therapy (HBOT)Patients with early-stage osteonecrosis of the femoral head treated with a combination of core decompression, stromal vascular fraction (SVF), and hyperbaric oxygen therapy (HBOT). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with early-stage osteonecrosis of the femoral head treated with triple-modal therapy at a single center.
Key inclusion criteria (5 listed)
- Patients diagnosed with Ficat-Arlet Stage II osteonecrosis of the femoral head
- Patients treated with combined core decompression, stromal vascular fraction (SVF), and hyperbaric oxygen therapy (HBOT)
- Age between 18 and 65 years
- Patients who completed all components of the treatment protocol
- Minimum follow-up duration of 24 months
Key exclusion criteria (7 listed)
- Patients with advanced-stage osteonecrosis (Ficat-Arlet Stage III-IV)
- Patients with a history of previous hip surgery
- Patients who previously received hyperbaric oxygen therapy for ONFH
- Patients who received prior cellular therapies (e.g., stem cell therapy or PRP) in the hip joint
- Patients with incomplete medical records
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Core decompressionSurgical procedure performed to reduce intraosseous pressure and improve blood flow in the femoral head. | Procedure or surgery | Triple-Modal Therapy Group |
| stromal vascular fraction (SVF)Autologous stromal vascular fraction containing mesenchymal stem cells applied to enhance bone regeneration. | Biological | Triple-Modal Therapy Group |
| Hyperbaric Oxygen Therapy (HBOT)Adjunctive hyperbaric oxygen therapy used to improve tissue oxygenation and promote healing. | Other | Triple-Modal Therapy Group |
Primary outcome
Change in Modified Harris Hip Score (MHHS)
Time frame: Baseline to 24 months
Assessment of clinical improvement using the Modifed Harris Hip Score in patients treated with triple-modal therapy.
2 secondary outcomes
Radiological progression of osteonecrosis
Time frame: Baseline to 24 months
Conversion to total hip arthroplasty (THA)
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- 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.
ibrahim alper yavuz, MD, PhD study chair
Ankara Bilkent City Hospital, Department of Orthopedics and Traumatology
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 Osteonecrosis of the Femoral Head, run by Ankara City Hospital Bilkent 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 5 inclusion and 7 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: finished, as of the sponsor's last update on 6 May 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Modified Harris Hip Score (MHHS) (time frame: Baseline to 24 months). 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 6 May 2026.