An observational study in Degenerative Disc Disease, Kyphosis and Scoliosis, sponsored by A-Spine Asia Co., Ltd.. Status unknown at 1 site in Taiwan. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-04-19.
Sponsored by A-Spine Asia Co., Ltd. · Observational
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.
462 studies on the registry are indexed under Intervertebral Disc Degeneration; 100 are open to participants now.
This study's planned enrollment of 200 is above the median of 119 across 170 observational studies indexed under Intervertebral Disc Degeneration.
Browse Intervertebral Disc Degeneration studies →This is the only study on the registry with A-Spine Asia Co., Ltd. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
The patients have implanted an A-SPINE device to stabilize the spine and/or restore the height of disc.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
As long as there are patients using the above device, conduct questionnaire interview.
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.
Time frame: Change from baseline at 2 year
Neck Disability Index
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.
Time frame: Baseline, 6 months, 12 months, 24 months
Oswestry Disability Index
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.
Time frame: Baseline, 6 months,12 months, 24 months
Number of Device-related Adverse Events
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.
Time frame: Baseline, 6 months,12 months, 24 months
Fusion Rate
Use X-ray or CT to detect the spine fusion.
Time frame: Baseline, 6 months,12 months, 24 months
Plan to share: Undecided
No publications or documents are linked to this record.
Started Sep 2019 (actual). Primary completion is estimated for Sep 2022, 35 months after the start.
Of 80 observational studies under Intervertebral Disc Degeneration, half reached primary completion within 61 months of starting (the median), counting those still running; a quarter within 45 and three quarters within 84. This study's planned 35 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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Intervertebral Disc Degeneration →