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

NCT04848376 | Unknown

• 1 other identifier: REC108-16
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Degenerative Disc Disease; Kyphosis; Scoliosis; Trauma; Tumor; Stenosis; Pseudoarthrosis of Spine; Deformity

Outcome Measures

Primary Outcomes (1)

• Visual Analogue Scale- Change from baseline at 2 year

  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.

  Change from baseline at 2 year

Secondary Outcomes (4)

• Neck Disability Index

  Baseline, 6 months, 12 months, 24 months

• Oswestry Disability Index

  Baseline, 6 months,12 months, 24 months

• Number of Device-related Adverse Events

  Baseline, 6 months,12 months, 24 months

• Fusion Rate

  Baseline, 6 months,12 months, 24 months

Study Arms (1)

Spine surgery

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

Device: (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

Interventions

(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 DEVICE

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

Spine surgery

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The patients have implanted an A-SPINE device to stabilize the spine and/or restore the height of disc.

You may qualify if:

• 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.

Sponsors & Collaborators

• A-Spine Asia Co., Ltd.: lead

Study Sites (1)

Taichung Tzu Chi Hospital

Taichung, 427213, Taiwan

RECRUITING

MeSH Terms

Conditions

Intervertebral Disc Degeneration; Kyphosis; Scoliosis; Wounds and Injuries; Neoplasms; Constriction, Pathologic; Congenital Abnormalities

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Spinal Curvatures; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Bryan Huang, MD

  Taichung Tzu Chi Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shu-Ting LIU, MS

CONTACT

+886-2-29267088; charlotte@aspine.com.tw

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2021
• First Posted: April 19, 2021
• Study Start: September 9, 2019
• Primary Completion: September 8, 2022
• Study Completion: September 8, 2022
• Last Updated: April 19, 2021

Record last verified: 2021-04

Locations

TW (1)