Clinical trials: Intervertebral Disc Replacement
Lumbar Disc Degeneration, Lumbar Disc Disease
Total Lumbar Disc Prosthesis and Subsequent Work Activity at at Least Five Years After Total Lumbar Disc Replacement
Lumbosciatica is a very prevalent pathology. When conservative treatments fail, surgery should be considered. The traditional surgical treatment is lumbar arthrodesis.
- Conditions
- Lumbar Disc Degeneration, Lumbar Disc Disease, Sciatica, Lumbar Disc Herniation
- Trial name
- NCT06989632
- Testing
- Total lumbar disc prosthesis (Baguera®L, Spineart, Switzerland)
- Where
- Spain
- Volunteers
- 130 people
- Sponsor
- University of Valencia
Degenerative Disc Disease, Lumbar, Disc Herniation, Lumbar
Satellite™ PEEK Nucleus Replacement Retrospective Analysis
The Satellite™ Retrospective Analysis is an international, retrospective, multi-center, non-interventional post-marketing study designed to document and analyze existing data with the device in a "real-world" setting.
- Trial name
- NCT01110967
- Where
- 3 sites in Czechia, Slovakia and 1 more
- Volunteers
- 40 people
- Sponsor
- Medtronic Spinal and Biologics
Cervical Intervertebral Disc Degeneration
Post-Market Study Evaluating the Safety and Effectiveness of NuNec® Cervical Arthroplasty System
The objective of this study is to evaluate long-term safety and effectiveness of the NuNec® Cervical Arthroplasty System in a small patient population. The NuNec device is currently CE marked and commercially available in Europe.
- Trial name
- NCT01832818
- Testing
- NuNec Cervical Disc
- Where
- United Kingdom
- Volunteers
- 14 people
- Sponsor
- Pioneer Surgical Technology, Inc.
Degenerative Disc Disease, Chronic Low-back Pain
Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nuclectomy
This study will be a prospective, open-label, multi-center study that will collect safety data for the minimally invasive PerQdisc Nucleus Replacement Device deployed to reduce chronic low back pain.
- Trial name
- LOPAIN1 (NCT04141098)
- Testing
- All patients that meet the inclusion/exclusion criteria will receive the PerQdisc® Nucleus Replacement Device.
- Where
- Paraguay
- Volunteers
- 9 people
- Sponsor
- Spinal Stabilization Technologies
Degenerative Disc Disease
XL TDR® eXtreme Lateral Total Disc Replacement for the Treatment of Lumbar Degenerative Disc Disease (DDD)
The purpose of this study is to evaluate the safety and effectiveness of XL TDR in patients with single-level degenerative disc disease compared to other devices approved by the FDA for the same or similar indications.
- Trial name
- XL TDR (NCT00927238)
- Testing
- XL TDR, Lumbar fusion surgery
- Where
- 17 sites in United States
- Volunteers
- 246 people
- Sponsor
- NuVasive
Low Back Pain
Wallis Stabilization System for Low Back Pain
The purpose of this study is to demonstrate that the Wallis System (interspinous process implant) is equivalent to total disc replacement (TDR) for the treatment of mild to moderate degenerative disc disease (DDD) of the lumbar…
- Trial name
- NCT00484458
- Testing
- Interspinous process and dynamic stabilization (Wallis System), Total Disc Replacement
- Where
- 11 sites in United States
- Volunteers
- 340 people
- Sponsor
- Zimmer Spine
Intervertebral Disc Disorder Cervical
Triadyme-C, a Polycrystalline Diamond Compact Cervical Disc Replacement (cTDR)
This Post Market Clinical Follow-up (PMCF) is conducted to collect clinical and radiographic outcome information on patients suffering from intractable symptomatic cervical disc disease requiring 1- or 2-level reconstruction of…
- Trial name
- NCT02967575
- Testing
- cTDR
- Where
- 4 sites in Germany
- Volunteers
- 100 people
- Sponsor
- Dymicron
Spine Surgery
3rd-year Post-surgical Evaluation of Adjacent Segment Disc Degeneration Onset in Lumbar Spine (Spinal Fusion vs. Lumbar Arthroplasty With Disc Replacement)
The main objective of the study is to compare the onset of adjacent segment disk degeneration in two groups of patients (one "spinal fusion group" and one "lumbar arthroplasty with disc replacement" group) with each patient…
- Trial name
- ARTHRO-DEGE (NCT05561322)
- Testing
- Consultation involving pain evaluation, questionnaires and the Lasègue Manoeuver, Magnetic Resonance Imaging of the lumbar spine
- Where
- France
- Sponsor
- Centre Hospitalier Universitaire de Nīmes
Degenerative Disc Disease, Chronic Low-back Pain
"Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2)
This study will be a prospective, open-label, multi-center study including 72 patients that will collect additional safety and efficacy data for the Spinal Stabilization Technologies PerQdisc Nucleus Replacement System.
- Trial name
- LOPAIN2 (NCT05508360)
- Testing
- PerQdisc Nucleus Replacement System
- Where
- 11 sites in Colombia, Costa Rica and 3 more
- Volunteers
- 72 people
- Sponsor
- Spinal Stabilization Technologies
Cervical Disc Degenerative Disorder
M6-C Artificial Cervical Disc Two-Level IDE Pivotal Study
Prospective, concurrently controlled, multi-center study to evaluate the safety and effectiveness of the Spinal Kinetics M6-C™ artificial cervical disc compared to anterior cervical discectomy and fusion (ACDF) for the treatment…
- Trial name
- NCT04982835
- Testing
- M6-C Artificial Cervical Disc, ACDF
- Where
- 21 sites in United States
- Volunteers
- 156 people
- Sponsor
- Orthofix Inc.
Degenerative Disc Disease
Maverick Total Disc Replacement in a 'Real World' Patient Population
The primary purpose of the study is to document the reduction of disability after Maverick total disc replacement surgery in a 'real-world' patient population requiring disc replacement.
- Trial name
- Maverick (NCT01338493)
- Testing
- lumbar spinal arthroplasty + Maverick™
- Where
- 13 sites in Canada, France and 1 more
- Volunteers
- 139 people
- Sponsor
- Medtronic Spinal and Biologics
Chronic Low Back Pain, Lumbar Degenerative Disc Disease
Safety and Performance Study of the CAdiscTM-L Lumbar Spinal Disc Replacement Device For CE Marking
The purpose of this European Union (EU) study to evaluate the safety and performance of the CAdiscTM-L Lumbar Spinal Disc Replacement Device in the surgical replacement of the lumbar intervertebral discs (L3 to S1) for patients…
- Trial name
- DISCERN (NCT00949936)
- Testing
- CAdisc™-L (Total Disc Replacement)
- Where
- 4 sites in Belgium, Germany and 2 more
- Sponsor
- Ranier Technology Limited
Cervical Degenerative Disc Disease
The Synergy Disc for the Treatment of 2 Level Cervical Degenerative Disc Disease Compared With Cervical Fusion Surgery
A multicenter, prospective, non-randomized, historically controlled study. To demonstrate the Synergy Disc is at least as safe and effective as conventional anterior cervical discectomy and fusion (ACDF) to treat cervical…
- Trial name
- NCT05740176
- Testing
- Anterior Cervical Discectomy and Fusion
- Where
- 23 sites in United States
- Volunteers
- 200 people
- Sponsor
- Synergy Spine Solutions
Degenerative Disc Disease, Chronic Low-back Pain
Safety Study for An Artificial Disc Nucleus Replacement to Treat Chronic Low Back Pain
This study will be a prospective, open-label, multi-center study that will collect safety data for the minimally invasive PerQdisc Nucleus Replacement Device deployed to reduce chronic low back pain.
- Trial name
- NCT04004156
- Testing
- PerQdisc® Nucleus Replacement Device.
- Where
- 4 sites in Belgium, Canada and 2 more
- Volunteers
- 9 people
- Sponsor
- Spinal Stabilization Technologies
Chronic Low Back Pain, Degenerative Disc Disease
Disc Prosthesis Versus Multidisciplinary Rehabilitation
Surgical methods offered to patients with chronic low back pain are controversial. In addition, new and expensive treatment methods like total disc replacemet (TDR) are a challenge for the health care services.
- Trial name
- NCT00394732
- Testing
- Total Disc Prosthesis, Multidisciplinary rehabilitation program
- Where
- 5 sites in Norway
- Volunteers
- 179 people
- Sponsor
- Ullevaal University Hospital
Degenerative Disc Disease
Safety and Efficacy Study of Healos as a Bone Replacement to Treat Degenerative Disc Disease
The purpose of this study is to determine the safety and effectiveness of HEALOS compared with autograft using the transforaminal lumbar interbody fusion (TLIF) method.
- Trial name
- NCT00316121
- Testing
- HEALOS and Leopard Cage, Leopard Cage and Autograft
- Where
- 17 sites in United States
- Volunteers
- 138 people
- Sponsor
- Advanced Technologies and Regenerative Medicine, LLC (ATRM)
Cervical Spondylosis
Effectiveness and Safety of Mobile Artificial Cervical Vertebrae Replacement for Patients With Cervical Spondylosis
The research team designed an artificial cervical joint prosthesis suitable for subtotal resection of the lower cervical vertebral body.
- Trial name
- NCT04813211
- Testing
- mobile artificial cervical vertebrae replacement, anterior cervical corpectomy and fusion
- Where
- China
- Volunteers
- 40 people
- Sponsor
- Xi'an International Medical Center Hospital
Lumbar Degenerative Disc Disease
CARES Lumbar Artificial Disc Registry
The purpose of the registry is to assess outcomes following treatment with lumbar total disc replacement (TDR) in patients outside the clinical trial setting.
- Trial name
- NCT02139527
- Testing
- Total Disc Replacement
- Volunteers
- 120 people
- Sponsor
- DePuy Spine
Lumbar Degenerative Disc Disease, Cervical Degenerative Disc Disease
Evaluation of the Prosthetic Disc Replacement
Until now, arthrodesis (intervertebral fusion) is the formal treatment for the lumbar and cervical degenerative disc disease : arthrodesis has been the standard surgical treatment for the patients when nonsurgical management has…
- Conditions
- Lumbar Degenerative Disc Disease, Cervical Degenerative Disc Disease, Kyphosis
- Trial name
- EVA (NCT00640029)
- Testing
- Arthrodesis, Arthroplasty (PRODISC-C® , PRODISC-L®, Mobi-C®, Mobidisc®, PrestigeLP®, A-Mav®, O-Mav®, DISCOCERV®)
- Where
- 2 sites in France
- Volunteers
- 301 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Degenerative Disc Disease
Clinical Outcomes of Lumbar Degenerative Disc Disease in Active-Duty U.S. Service Personnel
Degenerative disc disease (DDD) refers to a syndrome in which a degenerating disc causes chronic back pain, significantly impacting an individual's ability to function.
- Trial name
- NCT01028300
- Testing
- ProDisc™-L Total Disc Replacement (TDR)
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Synthes USA HQ, Inc.