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

  • days left to enroll
  • participants needed
  • sponsor
    A-Spine Asia Co., Ltd.
Updated on 28 April 2021


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.

Condition Kyphosis, Cancer, Cancer/Tumors, Neoplasms, Cancer (Pediatric), Ewing's Family Tumors, Cancer, Trauma, Wounds, Scoliosis, Wounds - qualifier, Stenosis, CONGENITAL ANOMALY NOS, Growth Hormone Deficiencies/Abnormalities, Female Hormonal Deficiencies/Abnormalities, Male Hormonal Deficiencies/Abnormalities, Birth Defects, Intervertebral Disc Degeneration, Growth Hormone Deficiencies/Abnormalities, Female Hormonal Deficiencies/Abnormalities, Cancer/Tumors, Male Hormonal Deficiencies/Abnormalities, Ewing's Family Tumors, Cancer (Pediatric), Wounds, Neoplasms, Birth Defects, Pseudoarthrosis of Spine, deformity, traumatic injury, traumatic disorder, degenerative disc disease
Treatment (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
Clinical Study IdentifierNCT04848376
SponsorA-Spine Asia Co., Ltd.
Last Modified on28 April 2021


Yes No Not Sure

Inclusion Criteria

Subject is above 20 years of age
Subject is indicated for A-SPINE Spinal Fixation System
Subject is willing and able to provide informed consent to participate in the study
Subject is willing and able to understand the purpose of the study, his/her role, and is available to return to the clinic/hospital for all required follow-up visits

Exclusion Criteria

Subjects will be excluded if, in the opinion of the Investigator, the subject does not qualify based on approved labeling requirements or Subject Inclusion Criteria
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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