Wounds and Injuries

All Conditions

Symptoms and General Pathology

Musculoskeletal Diseases

Neoplasms

Nervous System Diseases

Constriction, Pathologic

Intervertebral Disc Degeneration

Spondylolisthesis

Spinal Stenosis

Pseudarthrosis

Spinal Cord Neoplasms

Spinal Neoplasms

Spinal Diseases

Bone Diseases

Spondylolysis

Spondylosis

Central Nervous System Neoplasms

Nervous System Neoplasms

Spinal Cord Diseases

Central Nervous System Diseases

Bone Neoplasms

Fractures, Bone

Fractures, Ununited

The NEO Pedicle Screw System™ is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion.

NEO Pedicle Screw System™

Neo Cage System™ is intended to be used with bone graft material to facilitate interbody fusion and to be used with the NEO Pedicle Screw System™

Neo Cage System™

David C Noriega, PhD, MD

Yasser Abdalla, MD

The objectives of this clinical observational study is to evaluate the safety and efficacy (performance) of the Neo Pedicle Screw System™ and the Neo Cage System™ interbody fusion device. To demonstrate non-inferiority of safety and function to an historical control from the published medical literature on competitive devices.

PMCF Neo Pedicle Screw and Cage Systems

Fusion With the Neo Pedicle Screw and Cage Systems: A Post Market Clinical Follow-up Study

Clinical outcome in function as measured by the 100 point Oswestry Disability Index (ODI). Zero is equated with no disability and 100 is the maximum disability possible.

Defined as posterior movement of the cage past the posterior wall of the vertebral body.

A radiolucent zone, \>1mm, surrounding the pedicle screw seen in radiograhs

ConfinisCPM

Neo Medical SA

Diseases and Abnormalities at or Before Birth

Scoliosis

Congenital Abnormalities

Kyphosis

Spinal Curvatures

Use these system:

(1) SmartLoc (2) SmartLoc Evo(3) Winloc (4) Vigor PEEK Cervical Disc Spacer (5) Combo C (6) Polymer Lumbar Disc Spacer (7) X'Plo (8) Rainboo (9) Combo L

As long as there are patients using the above device, conduct questionnaire interview.

(1) SmartLoc (2) SmartLoc Evo (3) Winloc(4) Vigor PEEK Cervical Disc Spacer (5) Combo C (6) Polymer Lumbar Disc Spacer (7) X'Plo (8) Rainboo (9) Combo L

Shu-Ting LIU, MS

Bryan Huang, MD

This is a post-market clinical follow-up study that use questionnaires such as Visual Analog Scale (VAS), the Neck Disability Index (NDI), or the Oswestry Disability Index (ODI) to compare the clinical improvement effects before and after surgery.

The purpose of study is to confirm the safety and and performance of the A-SPINE's products for using 2 years. This post-market clinical follow-up study use questionnaires such as Visual Analog Scale (VAS), the Neck Disability Index (NDI), or the Oswestry Disability Index (ODI) to evaluate the clinical improvement effects. Subjects will be evaluated at pre-operation, 6 months, 12 months, and 2 years post treatment. Finally, analyze the clinical outcome, fusion rate, and adverse events.

Post-Market Clinical Follow-up Study of A-SPINE's Products

Visual Analogue Scale is a patient-reported outcome measure. The scale ranges from 0 to 10. A score of 0 represents no pain, while a score of 10 represents extreme pain. Compare baseline and postoperative improvement VAS scores.

The NDI is a questionnaire that is commonly used in clinical trials to measure the self-reported functional status of patients with neck pain.The ten questions are measured on a 6-point scale from 0 (no disability) to 5 (full disability). Compare baseline and postoperative improvement NDI scores.

The ODI is a questionnaire that is commonly used in clinical trials to measure the self-reported functional status of patients with neck pain.The ten questions are measured on a 6-point scale from 0 (no disability) to 5 (full disability). Compare baseline and postoperative improvement ODI scores.

Adverse events associated with the device will be assessed at each follow-up visit and the number of cases at the 2-year follow-up will be counted.

Use X-ray or CT to detect the spine fusion.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
PMCF Neo Pedicle Screw and Cage Systems	NCT03956537	Degenerative Di... Spondylolisthes... Spinal Stenosis Spinal Tumor Trauma Pseudoarthrosis...	NEO Pedicle Scr... Neo Cage System...	18 Years -	Neo Medical SA
Post-Market Clinical Follow-up Study of A-SPINE's Products	NCT04848376	Degenerative Di... Kyphosis Scoliosis Trauma Tumor Stenosis Pseudoarthrosis... Deformity	(1) SmartLoc (2...	20 Years - 80 Years	A-Spine Asia Co., Ltd.

Spots Global Cancer Trial Database for pseudoarthrosis of spine