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Triple-Modal Therapy in Early-Stage Femoral Head Osteonecrosis (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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07560163
Acronym
TM-ONFH
Enrollment
24
Registered
2026-04-30
Start date
2025-01-22
Completion date
2025-11-22
Last updated
2026-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteonecrosis of the Femoral Head

Keywords

Core Decompression, Stromal Vascular Fraction, Hyperbaric Oxygen Therapy, Hip Osteonecrosis

Brief summary

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.

Detailed description

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.

Interventions

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.

Sponsors

Ankara City Hospital Bilkent
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Modified Harris Hip Score (MHHS)Baseline to 24 monthsAssessment of clinical improvement using the Modifed Harris Hip Score in patients treated with triple-modal therapy.

Secondary

MeasureTime frameDescription
Radiological progression of osteonecrosisBaseline to 24 monthsEvaluation of disease progression using radiographic imaging.
Conversion to total hip arthroplasty (THA)24 monthsNumber of patients requiring total hip arthroplasty during follow-up.

Countries

Turkey (Türkiye)

Contacts

STUDY_CHAIRibrahim alper yavuz, MD, PhD

Ankara Bilkent City Hospital, Department of Orthopedics and Traumatology

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 7, 2026