UnknownPhase 4

Comparison of Rigid and Non-Rigid Interbody Fusion Device for Cervical Degenerative Disc Disease in Adults

Taiwan180 participantsStarted 2020-12-03

Plain-language summary

Rigid interbody fusion device in bulk configuration has been widely used in anterior cervical discectomy and fusion (ACDF) surgery. It is a randomized, prospective, multicenter clinical study to compare rigid and non-rigid fusion device in ACDF for cervical degenerative disc disease.

Who can participate

Age range

20 Years – 69 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Age 20 - 69 years;
. Symptomatic cervical degenerative disc disease in one or two levels between C3-7 with radiculopathy or myeloradiculopathy and/or decrease muscle strength and/or abnormal sensation and/or abnormal reflexes;
. Deficit confirmed by CT, MRI, or X-ray;
. NDI Score of ≥ 30/100;
. Unresponsive to non-operative treatment of at least 6 weeks or presence of progressive symptoms or signs of nerve root/spinal cord compression despite continued non-operative treatment;
. No prior surgical procedures at the operative level and non-prior fusions at any cervical level;
. Physically and mentally able and willing to comply with the protocol;

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change from baseline postoperative condition (if patients have major complications)

Timeframe: Patient were evaluated one month postoperatively, and 3, 6, 12, 18, and 24 months postoperatively.

Change from baseline postoperative condition (if patients have subsequent surgeries)

Timeframe: Patient were evaluated one month postoperatively, and 3, 6, 12, 18, and 24 months postoperatively.

Change from baseline Subsidence and Fusion rate

Timeframe: Patient were evaluated one month postoperatively, and 3, 6, 12, 18, and 24 months postoperatively.

Change from baseline Adjacent range of motion

Timeframe: Patient were evaluated preoperatively, one month postoperatively, and 3, 6, 12, 18, and 24 months postoperatively.

Change from baseline Neck Disability Index (NDI)

Timeframe: Patient were evaluated preoperatively, one month postoperatively, and 3, 6, 12, 18, and 24 months postoperatively.

Trial details

NCT IDNCT04550923

SponsorNational Taiwan University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-06-30

Contact for this trial

Dar-Ming Lai

+886-2312-3456 dmlai@ntu.edu.tw

View on ClinicalTrials.gov More Cervical Disc Degeneration trials

Who can participate

Age range

20 Years – 69 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Age 20 - 69 years;
. Symptomatic cervical degenerative disc disease in one or two levels between C3-7 with radiculopathy or myeloradiculopathy and/or decrease muscle strength and/or abnormal sensation and/or abnormal reflexes;
. Deficit confirmed by CT, MRI, or X-ray;
. NDI Score of ≥ 30/100;
. Unresponsive to non-operative treatment of at least 6 weeks or presence of progressive symptoms or signs of nerve root/spinal cord compression despite continued non-operative treatment;
. No prior surgical procedures at the operative level and non-prior fusions at any cervical level;
. Physically and mentally able and willing to comply with the protocol;

What they're measuring

Change from baseline postoperative condition (if patients have major complications)

Timeframe: Patient were evaluated one month postoperatively, and 3, 6, 12, 18, and 24 months postoperatively.

Change from baseline postoperative condition (if patients have subsequent surgeries)

Timeframe: Patient were evaluated one month postoperatively, and 3, 6, 12, 18, and 24 months postoperatively.

Change from baseline Subsidence and Fusion rate

Timeframe: Patient were evaluated one month postoperatively, and 3, 6, 12, 18, and 24 months postoperatively.

Change from baseline Adjacent range of motion

Timeframe: Patient were evaluated preoperatively, one month postoperatively, and 3, 6, 12, 18, and 24 months postoperatively.

Change from baseline Neck Disability Index (NDI)

Timeframe: Patient were evaluated preoperatively, one month postoperatively, and 3, 6, 12, 18, and 24 months postoperatively.

Comparison of Rigid and Non-Rigid Interbody Fusion Device for Cervical Degenerative Disc Disease in Adults

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Contact for this trial

Comparison of Rigid and Non-Rigid Interbody Fusion Device for Cervical Degenerative Disc Disease in Adults

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Contact for this trial

Exclusion criteria