Evaluation of DTRAX Graft in Patients With Cervical Degenerative Disc Disease

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.

Study Overview

• Status: Withdrawn
• Conditions: Cervical Radiculopathy; Cervical Spondylosis; Cervical Degenerative Disc Disease
• Intervention / Treatment: Device: DTRAX Graft

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94114
      • Office of Dr. Brian Andrews, Neurosurgery
    • San Francisco, California, United States, 94115
      • Neurospine Institute Medical Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 33 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Subject diagnosed with DDD in C3-C7, defined as follows:

   • Radiographically (at least one):

     • degenerated disc on MRI;
     • decreased disc height on plain film, CT or MRI; and/or
     • disc herniation, as demonstrated by CT or MRI.

   • Clinically: radicular symptoms (at least one):

     • arm/shoulder pain;
     • decreased reflexes;
     • decreased strength; and/or
     • decreased sensation.

2. Subject has single-level disease, OR multi-level disease demonstrated radiographically, and confirmed to be symptomatic by one of the following methods:

   • Selective nerve root block, OR
   • EMG, OR
   • Distinctive clinical examination.
3. Subject has dynamic stenosis relieved by traction and made worse by a Spurlings maneuver.
4. Subject is 35-80 years of age, inclusive.
5. 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.
6. Preoperative NDI score of ≥ 30.
7. Preoperative neck pain and arm pain score of ≥ 6 on Neck and Arm Pain Scales.
8. Patient is a male or non-pregnant, non-lactating female.
9. Female patients of child-bearing potential, including those who have had a tubal ligation, but excluding those who have not experienced a menstrual period for at least two years, must have a negative urine pregnancy test at Screening.
10. Patient must voluntarily provide written, informed consent.
11. Subject is able to meet the proposed follow-up schedule.
12. Subject is able to follow the postoperative management program.

Exclusion Criteria:

1. Subject has severe osteopenia, osteoporosis, osteomalacia, spinal metastases, or metabolic bone disease OR the level of BMD is a T score of -2.5 or below OR patient has sustained a vertebral compression or nontraumatic hip or wrist fracture.
2. Subject has overt or active spinal and/or systemic infection.
3. Subject has spondylolisthesis ≥ 3.5mm or rotator subluxation.
4. Subject has cervical myelopathy.
5. Subject has a chronic pain syndrome.
6. Subject has radicular findings with major motor impairment.
7. Subject has a condition that requires postoperative medications that interfere with fusion or the stability of the implant, such as steroids.
8. Subject is mentally incompetent.
9. Subject is a prisoner.
10. Subject is pregnant.
11. Subject abuses alcohol or drugs.
12. Subject has a cervical spinal condition other than symptomatic cervical disc disease requiring surgical treatment at the involved level.
13. Subject has insulin dependent diabetes.
14. Subject has chronic or acute renal failure or prior history of renal disease.
15. Subject has fever at the time of surgery, defined as > 38.5 degrees C.
16. Subject has documented allergy or intolerance to stainless steel, titanium, or a titanium alloy.
17. Subject has received drugs which may interfere with bone metabolism within two weeks prior to the planned date of DTRAX 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 DTRAX surgery or such treatment is planned during the 16 weeks following implantation of DTRAX Graft.
20. Subject is involved in spinal litigation or Workmen's Compensation claim.
21. Subject is obese, defined as body mass index (BMI) > 35.
22. Patient has psychiatric history, head injury or any other condition, which, in the Investigator's opinion, would prevent the patient from complying with postoperative follow-up visits.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: DTRAX graft	Device: DTRAX Graft; DTRAX Graft is an allograft implant inserted to support spinal fusion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gather clinical outcome data on DTRAX Graft.	Clinical outcome data will be collected using the Neck Disability Index (NDI), Visual Analogue Scale (VAS), and a quality of life questionnaire.	Baseline throughout 12 months post-operatively

Secondary Outcome Measures

Outcome Measure	Time Frame
Safety information will be evaluated by collecting the type, frequency, severity, device, and procedure-relatedness of adverse events.	Baseline throughout 12 months post-operatively

Collaborators and Investigators

• Sponsor: Providence Medical Technology, Inc.
• Investigators: Principal Investigator: Bruce McCormack, M.D., Neurospine Institute Medical Group; Principal Investigator: Brian Andrews, M.D., Office of Dr. Brian Andrews, Neurosurgery

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2012
• Primary Completion (Anticipated): February 1, 2014
• Study Completion (Anticipated): February 1, 2015

Study Registration Dates

• First Submitted: June 7, 2012
• First Submitted That Met QC Criteria: June 8, 2012
• First Posted (Estimate): June 12, 2012

Study Record Updates

• Last Update Posted (Actual): March 4, 2020
• Last Update Submitted That Met QC Criteria: March 2, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Bone Diseases; Intervertebral Disc Degeneration; Radiculopathy; Spinal Diseases; Spondylosis
• Other Study ID Numbers: PMT002