6 completed, 2 terminated, 1 unknown, 1 withdrawn. 7 Not applicable, 2 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Not applicable | 7 | Completed 5, Terminated 1, Withdrawn 1 |
| Phase 3 | 2 | Completed 1, Unknown 1 |
Follow Total Disc Replacement: new trials by email Literature Review of Total Disc Replacement trials Research Report on Total Disc Replacement
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| A Study Comparing the Outcome of Anterior Lumbar Fusion and Total Lumbar Disc Replacement Anterior Lumbar Interbody Fusion, Total Disc Replacement - Disc Disease Degenerative, Disk Degeneration | Not applicable | Withdrawn | Svante Berg | 2018-09-04 | 2020-12-16 | |
| Safety and Performance Study of the CAdiscTM-L Lumbar Spinal Disc Replacement Device For CE Marking CAdisc™-L (Total Disc Replacement) - Chronic Low Back Pain, Lumbar Degenerative Disc Disease | Not applicable | Completed | Ranier Technology Limited | 2009-10-01 | 2010-10-15 | |
| XL TDR® eXtreme Lateral Total Disc Replacement for the Treatment of Lumbar Degenerative Disc Disease (DDD) XL TDR, Lumbar fusion surgery - Degenerative Disc Disease | Phase 3 | Completed | NuVasive | 246 | 2009-07-01 | 2015-07-30 |
| Trial Evaluating the Safety and Effectiveness of NUBAC™ Disc Arthroplasty NuBac, Prodisc-L - Degenerative Disc Disease | Not applicable | Completed | Pioneer Surgical Technology, Inc. | 30 | 2009-02-01 | 2014-05-26 |
| CARES Lumbar Artificial Disc Registry Total Disc Replacement - Lumbar Degenerative Disc Disease | Terminated | DePuy Spine | 120 | 2007-05-01 | 2014-05-15 | |
| Wallis Stabilization System for Low Back Pain Interspinous process and dynamic stabilization (Wallis System), Total Disc Replacement - Low Back Pain | Phase 3 | Unknown | Zimmer Spine | 340 | 2007-01-01 | 2011-10-04 |
| Study of the Safety and Effectiveness of the Artificial Cervical Disc - Low Profile Device at Two Adjacent Levels PRESTIGE LP device at two adjacent levels, Bi-level fusion with ATLANTIS Cervical Plate System - Cervical Degenerative Disc Disease, Radiculopathy | Not applicable | Completed | Medtronic Spinal and Biologics | 397 | 2006-06-01 | 2018-05-01 |
| Kineflex|C Artificial Disc System to Treat Cervical Degenerative Disc Disease (DDD) Artificial disk, Artificial disc - Degenerative Disc Disease (DDD) | Not applicable | Terminated | SpinalMotion | 343 | 2005-07-01 | 2013-09-13 |
| Safety and Efficacy Study Comparing ProDisc-C to ACDF Surgery to Treat SCDD Total Disc Replacement, ACDF - Symptomatic Cervical Disc Disease | Not applicable | Completed | Synthes USA HQ, Inc. | 368 | 2003-08-01 | 2017-11-20 |
| Pivotal IDE Study of the BRYAN(R) Cervical Disc Prosthesis in the Treatment of DDD Versus ACDF ATLANTIS™ Cervical Plate System and allograft, BRYAN Cervical Disc Prosthesis - Radiculopathy, Myelopathy | Not applicable | Completed | Medtronic Spinal and Biologics | 494 | 2003-06-01 | 2016-05-13 |
Intervertebral Disc Degeneration (8) · Intervertebral disc disease (2) · Radiculopathy (2) · Spinal Cord Diseases (2) · Low Back Pain (1)
Medtronic Spinal and Biologics (2) · DePuy Spine (1) · NuVasive (1) · Pioneer Surgical Technology, Inc. (1) · Ranier Technology Limited (1) · SpinalMotion (1) · Svante Berg (1) · Synthes USA HQ, Inc. (1) · Zimmer Spine (1)
United States (6) · Belgium (1) · Germany (1) · Netherlands (1) · Sweden (1) · United Kingdom (1)
Christopher Bergin, MD (1) · Fred Geisler, MD (1) · John J. Regan, MD (1) · John K Burkus, M.D. (1) · Matthew Songer, MD (1) · Rick C Sasso, MD (1) · Svante Berg, MD, PhD (1) · William D Smith, MD (1)
PMID 21699471, PMID 23080427, PMID 23138404, PMID 27129045, PMID 28304237, PMID 28387616, PMID 29303467, PMID 31226684, PMID 31970051