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The safety and efficacy analysis of multiple injections of autologous vascular matrix components combined with self-setting calcium phosphate artificial bone and iliac bone grafting in the treatment of early to mid-stage femoral head necrosis

The safety and efficacy analysis of multiple injections of autologous vascular matrix components combined with self-setting calcium phosphate artificial bone and iliac bone grafting in the treatment of early to mid-stage femoral head necrosis.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600118059
Enrollment
Unknown
Registered
2026-02-02
Start date
2026-02-03
Completion date
Unknown
Last updated
2026-02-09

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

Interventions

Experimental group:In the self-curing calcium phosphate artificial bone, two injections of autologous vascular matrix components were performed according to the established protocol.
Control group:Only one SVF injection was performed during the surgery, with the injection dose, cell concentration, and localization method consistent with the experimental group.

Sponsors

Chinese People's Liberation Army General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1.Age 18–60 years; 2.Diagnosed with femoral head necrosis, radiological staging ARCO I–IIIA; 3.Planned for core decompression + calcium phosphate bone cement filling to preserve the hip; 4.Consent to accept SVF preparation and injection (single or multiple sessions); 5.Sign informed consent form.

Exclusion criteria

Exclusion criteria: 1History of previous hip joint replacement or major surgery on the same side; 2.Active infection or infection at the injection/surgical site; 3.Severe coagulation dysfunction or inability to discontinue anticoagulation/antiplatelet drugs and not suitable for puncture; 4.Severe heart, liver, renal dysfunction or unable to tolerate surgery; 5.Malignant tumor, pregnancy/lactation; 6.Other conditions deemed unsuitable for enrollment by the researcher.

Design outcomes

Primary

MeasureTime frame
12-month incidence of THA;

Secondary

MeasureTime frame
Assessment of hip joint function;Assessment of pain degree;Gait analysis;Appraisal of life quality;

Countries

China

Contacts

Public ContactPeng Jiang

Chinese People's Liberation Army General Hospital

pengjiang301@126.com+86 139 1006 0749

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 15, 2026