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

April 30, 2026 updated by: İbrahim Alper YAVUZ, Ankara City Hospital Bilkent

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

24

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with early-stage osteonecrosis of the femoral head treated with triple-modal therapy at a single center.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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).
Procedure: Core decompression
Surgical procedure performed to reduce intraosseous pressure and improve blood flow in the femoral head.
Biological: stromal vascular fraction (SVF)
Autologous stromal vascular fraction containing mesenchymal stem cells applied to enhance bone regeneration.
Other: Hyperbaric Oxygen Therapy (HBOT)
Adjunctive hyperbaric oxygen therapy used to improve tissue oxygenation and promote healing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Modified Harris Hip Score (MHHS)
Time Frame: Baseline to 24 months
Assessment of clinical improvement using the Modifed Harris Hip Score in patients treated with triple-modal therapy.
Baseline to 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiological progression of osteonecrosis
Time Frame: Baseline to 24 months
Evaluation of disease progression using radiographic imaging.
Baseline to 24 months
Conversion to total hip arthroplasty (THA)
Time Frame: 24 months
Number of patients requiring total hip arthroplasty during follow-up.
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara City Hospital Bilkent

Investigators

  • Study Chair: ibrahim alper yavuz, MD, PhD, Ankara Bilkent City Hospital, Department of Orthopedics and Traumatology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 22, 2025

Primary Completion (Actual)

September 22, 2025

Study Completion (Actual)

November 22, 2025

Study Registration Dates

First Submitted

April 24, 2026

First Submitted That Met QC Criteria

April 24, 2026

First Posted (Actual)

April 30, 2026

Study Record Updates

Last Update Posted (Actual)

May 6, 2026

Last Update Submitted That Met QC Criteria

April 30, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TABED 2-25-843

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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