CompletedNot Applicable

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

Turkey (Türkiye)24 participantsStarted 2025-01-22

Plain-language 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). 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.

Who can participate

Age range18 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Change in Modified Harris Hip Score (MHHS)

Timeframe: Baseline to 24 months

Trial details

NCT IDNCT07560163

SponsorAnkara City Hospital Bilkent

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-09-22