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 range

18 Years – 65 Years

Sex

ALL

See this in plain English?

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

View on ClinicalTrials.gov More Osteonecrosis of the Femoral Head trials