Ankara Bilkent City Hospital
Ankara, 06800, Turkey (Türkiye)
NCT Number: NCT07560163
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.
Looking for future studies?
Notify Me18 year–65 year
All sexes
Observational
Ankara, 06800, Turkey (Türkiye)
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Baseline to 24 months
Assessment of clinical improvement using the Modifed Harris Hip Score in patients treated with triple-modal therapy.
Time frame: Baseline to 24 months
Evaluation of disease progression using radiographic imaging.
Time frame: 24 months
Number of patients requiring total hip arthroplasty during follow-up.
Ankara City Hospital Bilkent
Other
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
Acronym: TM-ONFH
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07545018
Bone Diseases, Femur Head Necrosis
Baoding, Hebei, China
View Trial DetailsNCT01700920
Bone Diseases, Femur Head Necrosis
Salamanca, Castille and León, Spain
View Trial DetailsNCT07545616
Bone Diseases, Femur Head Necrosis
Xinxiang, Henan, China
View Trial DetailsNCT07471880
Bone Diseases, Femur Head Necrosis
Zhongshan, Guangdong, China
View Trial Details