WithdrawnNot Applicable

Evaluation of Cervical Fusion With DTRAX® Cervical Cage With DTRAX Bone Screw

Stopped: study not started due to lack of resources

United States0Started 2015-11

Plain-language summary

This study is being conducted to assess the radiographic (x-rays and CT scans) and clinical outcomes for the use of DTRAX Cervical Cage with DTRAX Bone Screw for the treatment of degenerative disc disease at one disc level with accompanying radicular symptoms in the cervical (neck) spine.

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 one level cervical spondylosis with radiculopathy in C3-C7, defined as follows:
. 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 clinically indicated sooner due to the presence of progressive symptoms or signs of nerve root in spite of combined nonoperative management.
. Preoperative Neck Disability Index (NDI) score of \> 30.
. Preoperative Neck pain or Arm pain score of \> 6 on Neck and Arm VAS Pain Scales.
. Subject is a male or non-pregnant, non-lactating female.

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

Assess the radiographic outcome data on fusion status, device retention, and maintenance of segmental lordosis at the index level utilizing DTRAX Cervical Cage with DTRAX Bone Screw used in the treatment of cervical radiculopathy

Timeframe: Baseline throughout 24 months post-operatively

Trial details

NCT IDNCT02694250

SponsorProvidence Medical Technology, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-09

View on ClinicalTrials.gov More Cervical Radiculopathy trials

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 one level cervical spondylosis with radiculopathy in C3-C7, defined as follows:
. 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 clinically indicated sooner due to the presence of progressive symptoms or signs of nerve root in spite of combined nonoperative management.
. Preoperative Neck Disability Index (NDI) score of \> 30.
. Preoperative Neck pain or Arm pain score of \> 6 on Neck and Arm VAS Pain Scales.
. Subject is a male or non-pregnant, non-lactating female.

Evaluation of Cervical Fusion With DTRAX® Cervical Cage With DTRAX Bone Screw

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 Cervical Fusion With DTRAX® Cervical Cage With DTRAX Bone Screw

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