Clinical and Radiological Outcomes of Posterior Cervical Fusion With Medtronic Infinity Occipitocervical-Upper...
Degenerative Disc DiseaseThis study is being done to prospectively collect data on subjects having posterior cervical fusion surgery using the Medtronic Infinity system. Researchers plan to collect information from patients having this type of surgery in order to learn more about patient how patients do after the surgery, including the rate of bone healing following surgery. The goal is for 250 patients to take part in the study or for 500 screws to be used, whichever comes first. Each patient will need a varying amount of screws to be used during their surgery. Because we are measuring the accuracy of each individual screw and the surgeon will likely use multiple screws during each surgery, it is likely that the study will reach its goal of 500 screws before 250 patients are enrolled in the study.
PMCF Study to Evaluate the VERTICALE® Cervical System in Spine Surgery According to Its Intended...
Degenerative Disc Disease (DDD)Instabilities2 moreIn accordance with the European Medical Device Regulation MDR 2017/745/EU, the legal manufacturers of medical devices are obliged to evaluate medical devices with regard to their clinical performance and safety. The VERTICALE® Cervical System is intended for immobilization and stabilization of spinal segments of the craniocervical junction (occipital-C2), subaxial cervical spine (C3-C7) and upper thoracic spine (T1-T3). Primary Objective: To assess the functional outcome and clinical benefit of the VERTICALE® Cervical System for the patient using the NDI (Neck Disability Index) questionnaire. Primary endpoint hypothesis: The investigators hypothesize that NDI improves by at least 10% or 5 points at 12 months FU (Follow-Up) compared with preoperatively.
Retro Comparison of Subsidence Following Interbody Devices in Lumbar Spine
Degenerative Disc Disease (DDD)The objective of this retrospective study is an investigational clinical follow-up, of patients treated with interbody fusion devices (IBFD), both expandable (EXP) and static (STC), according to their intended use and cleared labeling to understand IBFD design and technique characteristics that affect occurrence rates of subsidence. Patients treated with IBFD's (both EXP and STC) according to their intended use and cleared labeling EXP IBFD's that expand in width and height demonstrate reduced occurrence of subsidence post-operatively when compared to EXP IBFD's that expand in height only and STC IBFD's. EXP IBFD's that are comprised of multi-material composition with Polyetheretherketone (PEEK) endplate contacting surfaces demonstrate reduced occurrence of subsidence on post-operative radiographs when compared to EXP and STC IBFD's that are primarily comprised of Ti with Ti endplate contacting surfaces. achieve radiographic fusion at a rate consistent with the state-of-the-art achieve significant improvements in pain and function compared to baseline experience adverse events at a frequency comparable to reported rates for TLIF or PLIF surgery not demonstrate any intraoperative complications during the implant process operative approach does not correlate with increased rates of subsidence
Real World Data Collection on the Synergy Cervical Disc
Cervical Disc DegenerationThis trial is a real world data (RWD) collection observational study, comprised of both prospective and retrospective arms, that will examine the safety and effectiveness of the Synergy Cervical Disc System in patients with degenerative cervical disc disease.
A Post Market Surveillance on INFUSE Bone Graft
Intervertebral Disc DegenerationSpinal Fusion1 moreThis study aims to evaluate the safety and effectiveness of INFUSE™ Bone Graft in the real-world setting in Korea.
Evidence For Fusion In Spine With Orthoss®
Lumbar Spondylolisthesis Involving L4-L5Lumbar Spondylolisthesis Involving L5-S12 moreThis study aims to evaluate the performance and safety of the Orthoss® as a bone graft extender in lumbar spondylodesis involving 1-2 levels (L4-L5 and/or L5-S1).
LISA Post Market Clinical Follow-Up Study: Documentation of Clinical Outcomes After Surgery With...
Chronic Low-back PainHerniated Disc2 moreThe study is a post-market surveillance study of the Lumbar Implant for Stiffness Augmentation (LISA), a medical device, which is used to treat low-back pain that accompanies degenerative lesions of grades II, III, and IV (Pfirrmann MRI classification). "Post-market" means the device (i.e. the LISA implant) being used in this study has already obtained CE certification and is commercially available for use in the European market. The LISA device consists of 3 components: A PEEK interspinous spacer, a polyester band, and a titanium blocker. The spacer is positioned between two adjacent spinous processes, the band is belted around the spinous processes and through the spacer, and the blocker is used to lock the band inside the spacer. Medical Device manufacturers conduct "post-market" clinical studies in order to continuously evaluate the product scientifically and to comply with legal and ethical obligations. With these studies, the long-term safety as well as performance of their medical devices are assessed. This study, which is initiated and sponsored by BACKBONE (LISA designer, developer, manufacturer and marketer), aims to evaluate the long-term safety and performance of the LISA implant for the treatment of lumbar degenerative disease and to evaluate the treatment.
Interbody Systems: Post Market Clinical Follow-up Study
Degenerative Disc DiseaseThis is a prospective, multi-center study of subjects who will undergo spinal fusion surgery utilizing Stryker Interbody Systems that require post market clinical follow up (PMCF). The primary study hypothesis for each system is that the mean change in NDI (cervical) or ODI (lumbar) from baseline to Month 12 < -10, that is, the mean improvement exceeds 10 points. In supporting analysis, the same hypotheses will be tested for mean change from baseline to 24 months to demonstrate durability of effectiveness.
Dynamic Cervical Implant (DCI) Versus Anterior Cervical Discectomy And Fusion(ACDF) For The Treatment...
Cervical Degenerative Disc DiseaseTO Compare The Clinical And Radiographic Outcomes of DCI VS ACDF For The Treatment Of Single-Level Cervical Degenerative Disc Disease (DDD)
OssDsign® Spine Registry Study ("Propel")
Degenerative Disc DiseaseSpinal StenosisThe purpose of this multi-center, prospective, observational registry is to gather information on the clinical outcomes and real-world use of commercially available bone graft substitutes manufactured by OssDsign® AB, in patients who require spine fusion.