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CompletedNo phase

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