NCT07560163

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 22, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 22, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 22, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 24, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 30, 2026

Completed
Last Updated

May 6, 2026

Status Verified

April 1, 2026

Enrollment Period

8 months

First QC Date

April 24, 2026

Last Update Submit

April 30, 2026

Conditions

Osteonecrosis of the Femoral Head

Keywords

Core DecompressionStromal Vascular FractionHyperbaric Oxygen TherapyHip Osteonecrosis

Outcome Measures

Primary Outcomes (1)

  • Change in Modified Harris Hip Score (MHHS)

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

    Baseline to 24 months

Secondary Outcomes (2)

  • Radiological progression of osteonecrosis

    Baseline to 24 months

  • Conversion to total hip arthroplasty (THA)

    24 months

Study Arms (1)

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 decompressionBiological: stromal vascular fraction (SVF)Other: Hyperbaric Oxygen Therapy (HBOT)

Interventions

Core decompressionPROCEDURE

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

Triple-Modal Therapy Group
stromal vascular fraction (SVF)BIOLOGICAL

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

Triple-Modal Therapy Group
Hyperbaric Oxygen Therapy (HBOT)OTHER

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

Triple-Modal Therapy Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, 06800, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Legg-Calve-Perthes Disease

Interventions

Hyperbaric Oxygenation

Condition Hierarchy (Ancestors)

Femur Head NecrosisOsteonecrosisBone DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Oxygen Inhalation TherapyRespiratory TherapyTherapeutics

Study Officials

  • ibrahim alper yavuz, MD, PhD

    Ankara Bilkent City Hospital, Department of Orthopedics and Traumatology

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 24, 2026

First Posted

April 30, 2026

Study Start

January 22, 2025

Primary Completion

September 22, 2025

Study Completion

November 22, 2025

Last Updated

May 6, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)