Triple-Modal Therapy in Early-Stage Femoral Head Osteonecrosis (TM-ONFH)
Key facts
- Who runs it
- Ankara City Hospital Bilkent
- Where
- Türkiye1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- People taking part
- 24 people enrolled
- Started
- 22 Jan 2025
- Ended
- 22 Nov 2025
- Type of study
- Observational
- Treatments tested
- Core decompression
- stromal vascular fraction (SVF)
- Hyperbaric Oxygen Therapy (HBOT)
- Record updated
- 6 May 2026
Who can take part
- Age
- 18 years to 65 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 12 criteriaShow less
Who can take part
- 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 take part
- 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 advanced-stage osteonecrosis (Ficat-Arlet Stage III-IV)
- Patients with incomplete medical records
- Patients who did not complete the full treatment protocol
- Patients with follow-up duration less than 24 months
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
The group in the trial
- 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).
Treatment: Core decompression, stromal vascular fraction (SVF), and Hyperbaric Oxygen Therapy (HBOT)
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- 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
- Record updated
- 6 May 2026