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Comparison of the Efficacy of 3D Printed Interbody Fusion Cage and Traditional Interbody Fusion Cage In Lumbar Interbody Fusion: A Prospective Non-Inferiority Randomized Controlled Trial

Comparison of the Efficacy of 3D Printed Interbody Fusion Cage and Traditional Interbody Fusion Cage In Lumbar Interbody Fusion: A Prospective Non-Inferiority Randomized Controlled Trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100046610
Enrollment
Unknown
Registered
2021-05-23
Start date
2022-04-01
Completion date
Unknown
Last updated
2022-01-04

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

Conditions

Lumbar Degenerative Disease

Interventions

Control Group:Traditional PEEK Interbody Fusion Cage
Experimental Group:3D Printing Interbody Fusion Cage

Sponsors

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

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Lumbar disc herniation and compression cause lower extremity neurological symptoms that require lumbar disc removal and interbody fusion and internal fixation; 2. Strict conservative treatment is invalid for 3 months before operation; 3. The number of segments that need to be treated for lumbar interbody fusion is less than or equal to 2; 4. Aged >= 18 and < 65 years; 5. Those who intend to undergo initial lumbar fusion; 6. Sign the informed consent form voluntarily.

Exclusion criteria

Exclusion criteria: 1. Lumbar fractures; 2. Obvious local or systemic severe infection; 3. Severe osteoporosis (T<-3.5); 4. Consider minimally invasive surgery to remove acute lumbar disc herniation; 5. The patient is unwilling or unable to follow the instructions of the postoperative treatment and/or rehabilitation plan; 6. Other circumstances that the researcher judges are not suitable for selection; 7. The patient is mentally incapable or unable to understand the requirements for participating in the research.

Design outcomes

Primary

MeasureTime frame
Interbody fusion rate;Range of intervertebral motion;

Secondary

MeasureTime frame
Lumbar function score;VAS of lumbar pain;Intraoperative bleeding volume;Number of intraoperative fluoroscopy;Postoperative drainage;Postoperative indwelling time of drainage tube;Postoperative activity time out of bed;VAS of leg pain;

Countries

China

Contacts

Public ContactLi Yuxi

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

liyx73@mail.sysu.edu.cn+86 13480201345

Outcome results

None listed

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