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Core decompression combined with allogeneic bone grafting in the treatment of steroid induced avascular necrosis of the femoral head at Arco II: a prospective, randomized controlled and superiority trial study

Core decompression combined with allogeneic bone grafting in the treatment of steroid induced avascular necrosis of the femoral head at Arco II: a prospective, randomized controlled and superiority trial study

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100053425
Enrollment
Unknown
Registered
2021-11-20
Start date
2022-04-01
Completion date
Unknown
Last updated
2022-09-26

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

Conditions

Femoral head necrosis

Interventions

Control Group:Femoral head core decompression
Test group:Core decompression combined with allogeneic bone grafting

Sponsors

Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-50 years; 2. Patients with femoral head necrosis caused by hormone therapy; 3. Stage II patients according to ARCO stage of femoral head necrosis; 4. Patients who understand the purpose of the trial, voluntarily sign the informed consent form, and agree to complete the entire research process in accordance with the requirements of the protocol.

Exclusion criteria

Exclusion criteria: 1. Patients who have undergone surgical treatment of the femoral head; 2. Accompanied by acute or severe infection; 3. Patients with severe cardiovascular and cerebrovascular diseases, diabetes, coagulation disorders, mental and nervous system diseases, etc., with a history of severe osteoporosis, calcium and phosphorus metabolism disorders, drug abuse, etc.; 4. Patients with acute exacerbation of chronic diseases; 5. Patients with malignant disease and the survival period is less than 24 months; 6. Liver function exceeding 1.5 times the normal range; 7. Those whose creatinine level exceeds 1.5 times the normal range; 8. Women who are planning to become pregnant; 9. Pregnant and lactating women; 10. Patients with poor compliance and unable to follow up on time; patients who participated in other clinical trials during the same period but did not reach the end point; other patients who were deemed unsuitable by the investigator to participate in this trial.

Design outcomes

Primary

MeasureTime frame
Hip Harris Score;Association Research Circulation Osseous;

Secondary

MeasureTime frame
visual analogue scale;Surgery related complications;Length of stay;Operation time;Perioperative bleeding;

Countries

China

Contacts

Public ContactXu Jie

Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

lplllpfe@163.com+86 13392458585

Outcome results

None listed

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