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Clinical Trial Plan for the Safety and Efficacy Appraisal of HK.SWT-007 Shock Wave Therapy System in the Treatment of Hip Joint Pain Caused by Femoral Head Necrosis

Clinical Trial Plan for the Safety and Efficacy Appraisal of HK.SWT-007 Shock Wave Therapy System in the Treatment of Hip Joint Pain Caused by Femoral Head Necrosis

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100046208
Enrollment
Unknown
Registered
2021-05-10
Start date
2021-05-18
Completion date
Unknown
Last updated
2021-12-21

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

Conditions

Necrosis of femoral head

Interventions

Experimental group:Extracorporeal shock wave therapy(ESWT)
Control group:Celecoxib is taken orally

Sponsors

The Third Medical Center of the PLA General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 75 years; 2. MRI imaging results were used to diagnose ARCO stage I-IV of femoral head necrosis. MRI imaging results in the first 4 weeks of the screening stage were available; 3. Unwilling to accept surgical treatment, agree not to use non-research treatment related to hip pain during the study period, such as drugs not related to the study and other physical therapy; 4. Voluntarily participate in the clinical trial, comply with the requirements of the clinical trial and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Severe heart disease, arrhythmia and hypertension; 2. A heart pacemaker is installed; 3. Patients with uncured hemorrhagic disease and coagulation dysfunction; 4. The use of anti-immune agents; 5. All kinds of tumor patients on the shockwave path; 6. Patients with thrombosis on the shockwave path; 7. All landowners pregnant women; 8. Shock wave incidence site of local infection and skin ulceration patients; 9. Patients with joint fluid leakage; 10. Attending researchers decide that they are not suitable to participate in this clinical trial.

Design outcomes

Primary

MeasureTime frame
Hip pain improvement rate at 2 weeks after completion of treatment;

Secondary

MeasureTime frame
Harris score;Visual Analogue Scale;Western Ontario and McMaster Universities Osteoarthritis Index;Quality of life questionnaire;

Countries

China

Contacts

Public ContactXing Gengyan

The Third Medical Center of the PLA General Hospital

xgy7766@263.net+86 13501384316

Outcome results

None listed

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