Triple-Modal Therapy in Early-Stage Femoral Head Osteonecrosis (TM-ONFH)

Ankara City Hospital Bilkent24 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Osteonecrosis of the Femoral Head

Interventions

Core decompressionPROCEDURE

Surgical procedure performed to reduce intraosseous pressure and improve blood flow in the femoral head.

stromal vascular fraction (SVF)BIOLOGICAL

Autologous stromal vascular fraction containing mesenchymal stem cells applied to enhance bone regeneration.

Hyperbaric Oxygen Therapy (HBOT)OTHER

Adjunctive hyperbaric oxygen therapy used to improve tissue oxygenation and promote healing.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Ankara Bilkent City Hospital

Ankara, Turkey (Türkiye)

Outcomes

Primary Outcomes

Change in Modified Harris Hip Score (MHHS)

Assessment of clinical improvement using the Modifed Harris Hip Score in patients treated with triple-modal therapy.

Time frame: Baseline to 24 months

Secondary Outcomes

Radiological progression of osteonecrosis

Evaluation of disease progression using radiographic imaging.

Time frame: Baseline to 24 months

Conversion to total hip arthroplasty (THA)

Number of patients requiring total hip arthroplasty during follow-up.

Time frame: 24 months

Data from ClinicalTrials.gov

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