Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00927238 | XL TDR® eXtreme Lateral Total Disc Replacement for the Treatment of Lumbar Degenerative Disc Disease (DDD) | PHASE3 | COMPLETED | 246 | — | — | Jul 1, 2009 | Jul 1, 2015 | Jul 30, 2015 | 17 | United States |
| Arm | Type | Description |
|---|---|---|
| XL TDR | EXPERIMENTAL | The XL TDR is indicated for reconstruction of the disc following discectomy in skeletally mature subjects with symptomatic degenerative disc disease (DDD) of the lumbar spine at one level from L1-L5. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history radiographic studies. |
| Outcomes from lumbar fusion study | OTHER | - |
| Name | Type | Description |
|---|---|---|
| XL TDR | DEVICE | This will be a lateral approach discectomy and reconstruction with the insertion of the XL TDR device. |
| Lumbar fusion surgery | OTHER | Lumbar fusion surgery |
Inclusion Criteria: * 18-70 years of age (inclusive and skeletally mature) at the time of surgery * Diagnosis of image-confirmed symptomatic DDD at one of the following levels: L1/L2, L2/L3, L3/L4, or L4/L5 * DDD diagnosed using patient history and image-confirmation such as (but not limited to), M...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Mesoblast Limited Sponsored ADR | MESO | 1 | PHASE3 | Rexlemestrocel-L + HA mixture, Saline |
| Creative Medical Technology Holdings, Inc. | CELZ | 1 | PHASE1 | CELZ-201-DDT |
| Stryker Corporation | SYK | 2 | NA | Undisclosed |
| Globus Medical Inc Class A | GMED | 6 | — | Undisclosed |
| Orthofix Medical, Inc. | OFIX | 1 | — | Undisclosed |