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Rehabilitation intervention for tissue engineering repair in the treatment of femoral head necrosis: a clinical trial of efficacy analysis

Rehabilitation intervention for tissue engineering repair in the treatment of femoral head necrosis: a clinical trial of efficacy analysis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400093874
Enrollment
Unknown
Registered
2024-12-13
Start date
2023-07-18
Completion date
Unknown
Last updated
2024-12-16

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

Conditions

femoral head necrosis

Interventions

intervention group:Participants randomly assigned to the intervention group (n=39) were asked to participate in one week of postoperative health education, five times a week of rehabilitation training
control group:Participants randomly assigned to the control group (n=40) were asked to attend one week of post-operative health education

Sponsors

the Fourth Medical Center of the Chinese People's Liberation Army General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1.Diagnosed with femoral head necrosis based on bilateral hip joint anteroposterior and lateral X-rays, bilateral hip joint CT, and bilateral hip joint MRI, and classified as ARCO Stage II or IIIA by the International Bone Circulation Research Association; 2.Age: 20-60 years, no gender restriction; 3.After treatment with tissue engineering repair; 4.Patients must be willing to undergo rehabilitation treatment and follow-up assessments for 8 months post-surgery, and must meet the inclusion criteria with written informed consent obtained from all participants in the clinical trial. 5.Health status must be permissible;

Exclusion criteria

Exclusion criteria: 1. Femoral head flattening (ACRO type stage IV) or articular cartilage collapse >2mm 2.A long history of hormone use 3. Septicemic arthritis, rapid-breaking arthritis, non-osteonecrotic metabolic bone diseases (e.g. Paget's disease, osteogenesis implasia, primary hyperparathyroidism, osteosclerosis, active local bone infections, immature bone development, disorders of the immune system, metabolic diseases (gout, rheumatism, etc.) 4. Patients in immunosuppressive state or taking immunosuppressive drugs 5. Have severe hepatic and renal insufficiency; (1) ALT or AST> 1.5 times the upper limit of normal value; (2) Cr > the upper limit of normal value 6. Patients with malignant tumor 7. Pregnant and lactating women 8. Skin infection at the time of surgery 9. Patients with other serious systemic diseases and psychosis and those who are not qualified as determined by the doctor 10. Unable to tolerate and unwilling to cooperate with rehabilitation training, unwilling to cooperate with the interview

Design outcomes

Primary

MeasureTime frame
Hip internal rotation range;

Secondary

MeasureTime frame
Hip function rating scale;visual analogue scale;36-item Short-Form;

Countries

China

Contacts

Public ContactPeng Jiang

the Fourth Medical Center of the 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 4, 2026