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



Status:Recruiting
Conditions:Neurology, Women's Studies
Therapuetic Areas:Neurology, Reproductive
Healthy:No
Age Range:35 - 80
Updated:4/21/2016
Start Date:November 2015
End Date:November 2019
Contact:Jon Lyons, PhD, MBA
Email:dtraxccb001@providencemt.com

Use our guide to learn which trials are right for you!

Evaluation of Cervical Fusion With DTRAX® Cervical Cage With DTRAX Bone Screw in Patients With Cervical Radiculopathy

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.


Inclusion Criteria:

1. Subject diagnosed with one level cervical spondylosis with radiculopathy in C3-C7,
defined as follows:

a. Radiographically (at least one): i. degenerated disc on MRI and/or CT; ii.
decreased disc height on MRI and/or CT; and/or iii. foraminal stenosis, as
demonstrated by MRI and/or CT. b. Clinically: radicular symptoms (at least one): i.
arm/shoulder pain; ii. decreased reflexes; iii. decreased strength; and/or iv.
decreased sensation.

2. Subject has dynamic stenosis relieved by traction and made worse by a Spurlings
maneuver.

3. Subject is 35-80 years of age, inclusive.

4. 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.

5. Preoperative Neck Disability Index (NDI) score of > 30.

6. Preoperative Neck pain or Arm pain score of > 6 on Neck and Arm VAS Pain Scales.

7. Subject is a male or non-pregnant, non-lactating female.

8. Subject must have the ability to understand and voluntarily provide written, informed
consent.

9. Subject is able to meet the proposed follow-up schedule.

10. Subject is able to follow the postoperative management program.

Exclusion Criteria:

1. Any previous cervical spinal surgery.

2. Subject has known osteoporosis, osteomalacia, spinal metastases, or metabolic bone
disease OR subject has sustained a vertebral compression or nontraumatic hip or wrist
fracture.

3. Subject has overt or active spinal and/or systemic infection.

4. Subject has cervical spondylolisthesis > 3.5mm or rotator subluxation.

5. Subject has cervical myelopathy.

6. Subject has a chronic pain syndrome.

7. Subject has radicular findings with major motor impairment.

8. Subject has a condition that requires postoperative medications that interfere with
fusion or the stability of the implant, such as steroids (ie. corticosteroids,
methotrexate, immunosuppressives).

9. Subject is mentally incompetent.

10. Subject is a prisoner.

11. Subject is pregnant.

12. Subject abuses alcohol or drugs.

13. Subject has a cervical spinal condition other than symptomatic cervical disc disease
requiring surgical treatment at the involved level.

14. Subject has insulin dependent diabetes.

15. Subject has chronic or acute renal failure or prior history of renal disease.

16. Subject has documented allergy or intolerance to stainless steel, titanium, or a
titanium alloy.

17. Subject has or is planning to receive drugs which may interfere with bone metabolism
within two weeks prior to or six months following the date of surgery.

18. Subject has history of an endocrine or metabolic disorder known to affect
osteogenesis.

19. Subject has had treatment with an investigational therapy within 28 days prior to
surgery or such treatment is planned during the 16 weeks following implantation of
DTRAX Cervical Cage with DTRAX Bone Screw.

20. Subject is involved in or planning spinal litigation or Workmen's Compensation claim.

21. Subject is morbidly obese, defined as body mass index (BMI) > 40.

22. Subject has a medical condition or extenuating circumstance that, in the
Investigator's opinion, would prevent the subject from complying with postoperative
follow-up visits.
We found this trial at
5
sites
Johnson City, New York 13790
Principal Investigator: Khalid Sethi, M.D.
?
mi
from
Johnson City, NY
Click here to add this to my saved trials
Cary, North Carolina 27518
Principal Investigator: Sameer Mathur, M.D.
?
mi
from
Cary, NC
Click here to add this to my saved trials
Daytona Beach, Florida 32117
Principal Investigator: Mark Gillespy, M.D.
?
mi
from
Daytona Beach, FL
Click here to add this to my saved trials
East Syracuse, New York 13057
Principal Investigator: William Lavelle, M.D.
?
mi
from
East Syracuse, NY
Click here to add this to my saved trials
New Orleans, Louisiana 70112
Principal Investigator: Gabriel Tender, M.D.
?
mi
from
New Orleans, LA
Click here to add this to my saved trials