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
연구 개요
상태
정황
상세 설명
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.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Ankara, 터키 (Türkiye), 06800
- Ankara Bilkent City Hospital
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연구 인구
설명
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
공부 계획
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디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
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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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in Modified Harris Hip Score (MHHS)
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Radiological progression of osteonecrosis
기간: 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)
기간: 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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공동 작업자 및 조사자
수사관
- 연구 의자: ibrahim alper yavuz, MD, PhD, Ankara Bilkent City Hospital, Department of Orthopedics and Traumatology
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