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Completed

NCT Number: NCT07560163

Triple-Modal Therapy in Early-Stage Femoral Head Osteonecrosis (TM-ONFH)

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ankara Bilkent City Hospital

Ankara, 06800, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Core Decompression

Procedure

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Radiological progression of osteonecrosis

    Time frame: Baseline to 24 months

    Evaluation of disease progression using radiographic imaging.

  2. Conversion to total hip arthroplasty (THA)

    Time frame: 24 months

    Number of patients requiring total hip arthroplasty during follow-up.

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Official study 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

Acronym: TM-ONFH

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 30, 2026
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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