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Study on the clinical application of personalized medical implants in the precise treatment of joint and spinal diseases

Study on the clinical application of personalized medical implants in the precise treatment of joint and spinal diseases

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000040513
Enrollment
Unknown
Registered
2020-12-01
Start date
2020-11-30
Completion date
Unknown
Last updated
2021-03-08

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

Conditions

joint and spine diseases

Interventions

Case series:surgical treatment with personalized implants

Sponsors

Shanghai Ninth People’s Hospital, Shanghai Jiao Tong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Participants aged 18-75 years; 2. Participants who need to undergo osteoarticle-spine reconstructive surgery for various osteoarticle-spine diseases (degenerative diseases of the lumbar spine, tuberculosis of the lumbar spine, tumors, infections and acetabular defects, etc.); 3. Did not participate in any other clinical trials within 3 months; 4. Did not undergo any spinal or joint related surgery within 6 months; 5. There is no improvement in the non-surgical treatment that has been performed for more than 3 months in the past year, and the existing commercial implants cannot meet the surgical needs; 6. Can understand the research program, participate in the study voluntarily, and sign the informed consent; 7. Willing to complete the experimental follow-up and data collection during the study.

Exclusion criteria

Exclusion criteria: 1. Participants unwilling to accept personalized reconstructive surgery; 2. Participants unable to tolerate anesthesia due to physical conditions; 3. Participants with severe osteoporosis (T <=-2.5 and complicated with brittle fracture); 4. Participants with tissue metabolism disorder, immune function disorder, drug abuse, etc.; 5. Participants with heart, lung, liver, kidney hematopoietic system, endocrine system and other serious primary diseases or mental diseases; 6. Allergic to metal or titanium alloy materials, allergic constitution or allergic to multiple drugs; 7. Pregnant and lactating women; 8. Participants are unwilling or unable to restrict activities or comply with the will; 9. The condition is critical, affecting the evaluation of the effectiveness and safety of the test apparatus.

Design outcomes

Primary

MeasureTime frame
Fusion stability;

Countries

China

Contacts

Public ContactZhao Jie

Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine

13301815365@189.cn+86 13301815365

Outcome results

None listed

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