UMIN ID: UMIN000001448
Registered date:21/10/2008
Clinical trial of porous bioactive titanium for lumbar spine fusion
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | Lumbar disc disease, lumbar spondylolisthesis, lumbar isthmic spondylolisthesis |
| Date of first enrollment | 2008/10/01 |
| Target sample size | 5 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Transforaminal lumbar interbody fusion |
Outcome(s)
| Primary Outcome | Intraoperative handling of the implant and avoidance of iliac crest bone graft harvesting. |
|---|---|
| Secondary Outcome |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | 80years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1) No hip and leg disease 2) No cervical or thoracic spine disease 3) No previous lumbar spinal fusion 4) No collagen disease 5) BMI over 30 6) No pregnancy 7) No severe osteoporosis 8) No uncontrolable general disease 9) No malignacy 10) No psychological disease 11) No severe bacterial disease 12) No steroid treatment |
Related Information
| Primary Sponsor | Kyoto University Hospital |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Kyoto University Hospital |
| Secondary ID(s) |
Contact
| public contact | |
| Name | |
| Address | Japan |
| Telephone | 075-751-3366 |
| Affiliation | Kyoto University Hospital Orthopaedic surgery |
| scientific contact | |
| Name | Masashi Neo |
| Address | Shogoin Kawaharacho 54, Sakyoku, Kyotosi Japan |
| Telephone | |
| Affiliation | Kyoto University Hospital Orthopaedic surgery |