WithdrawnNot Applicable

Evaluation of DTRAX Graft in Patients With Cervical Degenerative Disc Disease

Stopped: study was never started due to lack of resources

United States0Started 2012-05

Plain-language summary

DTRAX Graft is used to relieve nerve pressure in the neck in order to provide relief for Cervical Degenerative Disc Disease. This study is being conducted to determine the effectiveness of the graft, and to find out whether or not it provides better results or faster healing than traditional ways of performing surgery for Cervical Degenerative Disc Disease.

Who can participate

Age range

35 Years – 80 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

. Subject diagnosed with DDD in C3-C7, defined as follows:
. Subject has single-level disease, OR multi-level disease demonstrated radiographically, and confirmed to be symptomatic by one of the following methods:
. Subject has dynamic stenosis relieved by traction and made worse by a Spurlings maneuver.
. Subject is 35-80 years of age, inclusive.
. Subject is unresponsive to 6 weeks conservative, nonoperative treatment, or has the presence of progressive symptoms or signs of nerve root compression in face of combined nonoperative management.
. Preoperative NDI score of ≥ 30.
. Preoperative neck pain and arm pain score of ≥ 6 on Neck and Arm Pain Scales.

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

Gather clinical outcome data on DTRAX Graft.

Timeframe: Baseline throughout 12 months post-operatively

Trial details

NCT IDNCT01616719

SponsorProvidence Medical Technology, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2014-02

View on ClinicalTrials.gov More Cervical Spondylosis trials

Plain-language summary

Who can participate

Age range

35 Years – 80 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

. Subject diagnosed with DDD in C3-C7, defined as follows:
. Subject has single-level disease, OR multi-level disease demonstrated radiographically, and confirmed to be symptomatic by one of the following methods:
. Subject has dynamic stenosis relieved by traction and made worse by a Spurlings maneuver.
. Subject is 35-80 years of age, inclusive.
. Subject is unresponsive to 6 weeks conservative, nonoperative treatment, or has the presence of progressive symptoms or signs of nerve root compression in face of combined nonoperative management.
. Preoperative NDI score of ≥ 30.
. Preoperative neck pain and arm pain score of ≥ 6 on Neck and Arm Pain Scales.

Evaluation of DTRAX Graft in Patients With Cervical Degenerative Disc Disease

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Evaluation of DTRAX Graft in Patients With Cervical Degenerative Disc Disease

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria