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A Prospective Multicenter Clinical Trial of Repairing Large Cartilage Defects of Joints Using Autologous Costal Cartilage Grafts

A Prospective Multicenter Clinical Trial of Repairing Large Cartilage Defects of Joints Using Autologous Costal Cartilage Grafts

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000035736
Enrollment
Unknown
Registered
2020-08-16
Start date
2020-10-01
Completion date
Unknown
Last updated
2020-08-17

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

Conditions

Cartilage Defect of Joint

Interventions

Sponsors

Shanghai Sixth People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
16 Years to 55 Years

Inclusion criteria

Inclusion criteria: 1. Aged 16-55 years old, cartilage defect on hip, knee and ankle, male or female 2. Full-thickness large cartilage defect (3-20 cm2, International Cartilage Repair Society [ICRS] grade IV); 3. Medium or severe level pain (VAS4) with impaired joint function; 4. Be willing for surgical treatment; 5. Agree to take part into this clinical trial and signed the informed consent approved by the Ethic Committee.

Exclusion criteria

Exclusion criteria: 1. Systemic or inflammatory arthritis (e.g. rheumatoid arthritis), gout, a history of neuro-arthritis and other muscle, joint, or nervous system diseases that affect lower limb function; 2. Severe diabetes and other internal diseases which cause the patient cannot tolerate for the surgery; 3. Patient with immunosuppression or acute infection; 4. Obese, BMI>30; 5. Pregnant or Lactating women; 6. Existing cerebral disease or have a history of neurological and psychiatric disease; 7. Joint malformation or severe dysplasia; 8. Severe calcification of costal cartilage; 9. Unwillingness to comply with the protocol or procedures; 10. Other medical conditions that were not appropriate to participate in the study, including MRI contraindications (e.g. Patients with cardiac pacemaker installed).

Design outcomes

Primary

MeasureTime frame
Functional Scores (Harris for hip,HSS for knee, AOFAS for ankle);

Secondary

MeasureTime frame
Visual analogue scale;EQ-5D;Functional Scores (Harris for hip,HSS for knee, AOFAS for ankle);MOCART Scoring;Joint replacement or joint fusion;X-ray;CT scan;MRI;

Countries

China

Contacts

Public ContactChangqing Zhang

Shanghai Sixth People's Hospital

zhangcq@sjtu.edu.cn+86 021-24058009

Outcome results

None listed

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