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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Change in Modified Harris Hip Score (MHHS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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).
干预措施: Core decompression (Procedure)
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).
干预措施: stromal vascular fraction (SVF) (Biological)
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).
干预措施: Hyperbaric Oxygen Therapy (HBOT) (Other)
结局指标
主要结局
Change in Modified Harris Hip Score (MHHS)
时间窗: Baseline to 24 months
Assessment of clinical improvement using the Modifed Harris Hip Score in patients treated with triple-modal therapy.
次要结局
- Radiological progression of osteonecrosis(Baseline to 24 months)
- Conversion to total hip arthroplasty (THA)(24 months)
研究者
İbrahim Alper YAVUZ
Associate Professor
Ankara City Hospital Bilkent