Symptoms and General Pathology

All Conditions

Diseases and Abnormalities at or Before Birth

Musculoskeletal Diseases

Blood and Lymph Conditions

Neoplasms

Nervous System Diseases

Syndrome

Congenital Abnormalities

Constriction, Pathologic

Intervertebral Disc Displacement

Intervertebral Disc Degeneration

Spondylolisthesis

Spinal Stenosis

Bone Marrow Diseases

Spinal Cord Neoplasms

Failed Back Surgery Syndrome

Spinal Cord Diseases

Spinal Diseases

Bone Diseases

Central Nervous System Diseases

Postoperative Complications

Back Pain

Pain

Neurologic Manifestations

Hernia

Pathological Conditions, Anatomical

Central Nervous System Neoplasms

Nervous System Neoplasms

Patients who undergo a planned spinal fusion procedure requiring approved bone grafting materials (e.g., bone grft substitutes, allograft or autograft).

spine fusion surgery utilizing any commercially available bone graft substitute(s), autograft or allograft

Bone graft substitute, autograft or allograft

Huub Kreuwel, Ph.D

A multi-center, prospective, observational patient registry to collect information on the clinical outcomes and "real world" use of approved and commercially available bone graft substitutes, autograft and allograft.

Bone Graft Materials Observational Registry

A Prospective Patient Registry for Bone Graft Substitutes in Spinal Fusion: Patient Outcomes and Use in Clinical Practice

Apatech, Inc.

Baxter Healthcare Corporation

Wounds and Injuries

Radiculopathy

Thoracic Injuries

Trauma, Nervous System

Peripheral Nervous System Diseases

Neuromuscular Diseases

Kyle Malone, MS

The objective of this study is to evaluate the safety and performance of occipito-cervico-thoracic spine surgery using posterior fixation as measured by reported complications, radiographic outcomes, and patients reported outcomes (PROs).This study is being undertaken to identify possible residual risks and to clarify mid-to long-term clinical performance that may affect the benefit/risk ratio of posterior fixation systems.

This study is a prospective, uncontrolled, multicenter study to evaluate the safety and performance of select occipito-cervico-thoracic posterior fixation systems in patients who undergo posterior fixation fusion surgery. Consecutive patients at a given site who meet eligibility requirements will be asked to consent to participate in the study. These patients will present with traumatic, reconstructive, and/or tumor conditions in the craniocervical, cervical, and/or upper thoracic spine that are amenable to surgical treatment and will be screened prior to study enrollment. Once enrolled in the study, subjects will undergo posterior occipito-cervico-thoracic fixation surgery using one of the NuVasive posterior fixation systems (Vuepoint II OCT or Reline-C) based on the surgeon's standard of care. At least 150 subjects (a minimum of 75 in each implant arm) will be enrolled and will be followed for 24 months after the surgery.

Posterior Cervical Fixation Study

A Prospective, Multicenter Study Evaluating the Safety and Performance of Posterior Fixation in Trauma, Reconstructive, and Tumor Surgery of the Occipito-cervico-thoracic Spine

Rate of complications (i.e., safety) attributable to the use of the associated posterior fixation system.

The proportion of subjects with apparent radiographic success at:

1. Latest timepoint available for patients undergoing surgery to treat advanced stage tumors
2. 24 months postoperative for subjects undergoing surgery to treat instabilities, traumatic spinal fractures, failed previous fusions, or degenerative disease

Neck and arm pain measured using a visual analog scale (VAS) will be assessed to determine the percentage of subjects who meet MCID (2.5 points and 2.5 points respectively) where 0 is "No Pain" and 10 is "Unbearable Pain".

Disability measured by the neck disability index (NDI) will be assessed to determine the percentage of subjects who meet MCID (7.5 points) where a higher score on the NDI indicates a more severe disability.

Overall physical and mental health measured by PROMIS-10 will be assessed to determine the percentage of subjects who meet MCID (5 points). PROMIS-10 scoring uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.

Neck and arm pain measured using a visual analog scale (VAS) will be assessed to determine the percentage of subjects who meet SCB (3.5 points) where 0 is "No Pain" and 10 is "Unbearable Pain".

Disability measured by the neck disability index (NDI) will be assessed to determine the percentage of subjects who meet SCB (9.5 points) where a higher score on the NDI indicates a more severe disability.

Overall physical and mental health measured by PROMIS-10 will be assessed to determine the percentage of subjects who meet SCB (6.8 points). PROMIS-10 scoring uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.

Rate of complications attributable to the use of any additional NuVasive instruments, implants, or technologies.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Bone Graft Materials Observational Registry	NCT00974623	Degenerative Di... Herniated Disc Spinal Stenosis Spondylolithesi... Spinal Deformit... Cervical Myelop... Failed Back Sur... Spinal Cord Neo...	Bone graft subs...	18 Years -	Baxter Healthcare Corporation
Posterior Cervical Fixation Study	NCT04770571	Degenerative Di... Craniocervical ... Cervical Radicu... Cervical Disc D... Cervical Fusion Cervical Spine ... Cervical Myelop... Cervical Instab... Thoracic Injury		18 Years -	NuVasive

Spots Global Cancer Trial Database for cervical myelopathy