Clinical Application Research of Optimized ESWT for Osteonecrosis of the femoral head Based on VR/AR Real-time Visualization Virtual Simulation System

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2400090340

Enrollment

Unknown

Registered

2024-09-27

Start date

2024-11-01

Completion date

Unknown

Last updated

2024-09-30

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

Conditions

Glucocorticoid-induced osteonecrosis of the femoral head

Interventions

experimental group:Optimized ESWT for Osteonecrosis of the femoral head Based on VR/AR Real-time Visualization Virtual Simulation System, combined with hip preservation drug therapy

control group:Perform traditional extracorporeal shock wave therapy, combined with hip preservation drug therapy

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Age from 18 to 65 years old, gender is not limited. Glucocorticoid-induced osteonecrosis of the femoral head in early and middle stages (ARCO Stage I, II, IIIa), and extracorporeal shock wave technique was selected for hip preservation. Being able to understand this research, and sign the informed consent form

Exclusion criteria

Exclusion criteria: Patients who with severe primary disease, so are not suitable to participate in this study. Patients who were not eligible for diagnosis of osteonecrosis of the femoral head before inclusion; Pregnant or lactating women; Allergic constitution and allergy to multiple drugs; Complicated with severe cardiovascular and cerebrovascular diseases, liver and renal insufficiency (liver function test ALT or AST is more than 2 times the upper limit of normal value, renal function test creatinine or urea nitrogen exceeds the upper limit of normal), diseases of the hematopoietic system, severe digestive tract diseases, severe underlying diseases of mental and central nervous system; Having bleeding tendency or vascular insufficiency; Not suitable for MRI examination(claustrophobia, heart pacemaker, contraceptive ring, etc.); Other circumstances where researchers considered them inappropriate to participate in this study.

Design outcomes

Primary

Measure	Time frame
Progression rate of the femoral head necrosis;	—

Secondary

Measure	Time frame
Necrotic surface area and necrotic surface area ratio of the femoral head;Location of necrotic focus of the femoral head;Pain Visual Analogue Scale;Hip Harris score;Evaluation of safety indicators - Adverse events;	—

Countries

China

Contacts

Public ContactGao Fuqiang

China-Japan Friendship Hospital

gaofuqiang@bjmu.edu.cn+86 189 0126 7995

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026