Triple-Modal Therapy in Early-Stage Femoral Head Osteonecrosis (TM-ONFH) (TM-ONFH)
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
研究概览
地位
条件
详细说明
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.
研究类型
注册 (实际的)
联系人和位置
学习地点
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Ankara、土耳其（türkiye）、06800
- Ankara Bilkent City Hospital
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
取样方法
研究人群
描述
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
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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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).
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Surgical procedure performed to reduce intraosseous pressure and improve blood flow in the femoral head.
Autologous stromal vascular fraction containing mesenchymal stem cells applied to enhance bone regeneration.
Adjunctive hyperbaric oxygen therapy used to improve tissue oxygenation and promote healing.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in Modified Harris Hip Score (MHHS)
大体时间：Baseline to 24 months
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Assessment of clinical improvement using the Modifed Harris Hip Score in patients treated with triple-modal therapy.
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Baseline to 24 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Radiological progression of osteonecrosis
大体时间：Baseline to 24 months
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Evaluation of disease progression using radiographic imaging.
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Baseline to 24 months
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Conversion to total hip arthroplasty (THA)
大体时间：24 months
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Number of patients requiring total hip arthroplasty during follow-up.
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24 months
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合作者和调查者
调查人员
- 学习椅：ibrahim alper yavuz, MD, PhD、Ankara Bilkent City Hospital, Department of Orthopedics and Traumatology
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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