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To optimize the scheme and verify the efficacy of visualization acupotomology in improving the joint function of patients with osteonecrosis of the femoral head "survival with collapse"

To optimize the scheme and verify the efficacy of visualization acupotomology in improving the joint function of patients with osteonecrosis of the femoral head "survival with collapse"

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2024000617
Enrollment
Unknown
Registered
2024-10-29
Start date
2024-11-01
Completion date
Unknown
Last updated
2024-11-11

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:Primary therapy and visualization acupotomy
Control group:Primary therapy and Traditional acupotomy

Sponsors

Wangjing Hospital of China Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) Meet the above diagnostic criteria for femoral head necrosis and the femoral head has collapsed (ARCOIII-IV stage);Diagnostic criteria: refer to the international diagnostic criteria proposed by Mont et al 1) Specificity criteria 1. Collapse of the femoral head 2 X-rays of subcartilage linear translucent opacity 3 anterolateral dead bones 4 ECT shows a radioactive increase band surrounding the hyporadiation-low zone 5 MRI T2-weighted phase bilinear sign 6. Bone biopsy: Bone pit is empty 2) Non-specific criteria 1. Collapse of the femoral head with narrowing of the joint space 2. Speckled cystic changes and osteosclerosis in the femoral head are mixed 3. Increased bone scanning activity 4 MRI showed bone marrow edema 5. Pain when the hip joint is moved but the X-ray is normal 6. History of alcohol consumption or hormone use 7. Bone biopsy bone marrow edema or fibrosis As long as one of the specific and nonspecific indicators is satisfied the diagnosis is established. 2) Patients with no obvious pain or less severe pain (VAS score =3 points) combined with limited hip mobility; 3)Age 18-75 male or female 4)Imaging showed that the necrotic area was well repaired the anterior or lateral wall of the femoral head was preserved the relationship between the femoral head and the acetabulum was matched and there was no subluxation of the femoral head. 5) Volunteer to participate in this study and agree to sign ethical informed consent.

Exclusion criteria

Exclusion criteria: 1) Imaging indicated that the necrotic area involved the anterior lateral wall of the femoral head and the risk of further collapse of the femoral head was high; 2)Patients with severe cardiovascular cerebrovascular hematopoietic and other primary diseases especially those with abnormal coagulation function are not suitable for needle-knife treatment; 3) Patients with joint infection or other diseases especially patients with skin damage and ulceration at the acupotomy site; 4) Pregnant and lactating women; 5) Participants participating in other clinical studies or receiving other related treatments within 30 days prior to enrollment which may affect the efficacy observation indicators of this study;

Design outcomes

Primary

MeasureTime frame
Harris hip function Score;

Secondary

MeasureTime frame
Hip effusion score;Serum inflammatory factors (IL-6 IL-1ß TNF-a);vasomotor factors (NO ET-1 NE HIS);Total score of TCM clinical efficacy evaluation of femoral head necrosis;Improved Ashworth score;9/5000 Classification of femoral head bone marrow edema;The short-form 36 item health survey questionnaire;

Countries

China

Contacts

Public ContactHaijun He

Wangjing Hospital of China Academy of Chinese Medical Sciences

drhjhe@126.com13811436750

Outcome results

None listed

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