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

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.

Study Overview

• Status: Withdrawn
• Conditions: Cervical Radiculopathy
• Intervention / Treatment: Device: DTRAX® Cervical Cage with DTRAX Bone Screw

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94115
      • Neurospine Institute Medical Group
  • Florida
    • Daytona Beach, Florida, United States, 32117
      • Daytona Orthopaedic and Spinal Research Group
    • Tampa, Florida, United States, 33637
      • Foundation for Orthopaedic Research and Education
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Louisiana State University Health Sciences Center - New Orleans (LSUHSC - NO)
  • New York
    • East Syracuse, New York, United States, 13057
      • Upstate Orthopedics
    • Johnson City, New York, United States, 13790
      • Southern New York NeuroSurgical Group, P.C.
  • North Carolina
    • Cary, North Carolina, United States, 27518
      • Cary Orthopaedic Spine Specialists

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

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 Cervical Cervical Cage with DTRAX Bone Screw	Device: DTRAX® Cervical Cage with DTRAX Bone Screw; DTRAX Cervical Cage is an intervertebral fusion device that provides mechanical support to the spine. DTRAX Cervical Cage is intended to be used in cervical spine fusion surgery. DTRAX Bone Screw is indicated for use in arthrodesis and provides supplemental fixation. .

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	Baseline throughout 24 months post-operatively

Secondary Outcome Measures

Outcome Measure	Time Frame
Assess the clinical outcome data based Neck Disability Index (NDI)	Baseline throughout 24 months post-operatively
Assess the clinical outcome data based SF-12 v2 Health Survey	Baseline throughout 24 months post-operatively
Assess the clinical outcome data based the Visual Analogue Scale (Neck and Arm VAS)	Baseline throughout 24 months post-operatively
Safety information will be evaluated by collecting the type, frequency, severity, and device and procedure-relatedness of adverse events	Baseline throughout 24 months post-operatively

Collaborators and Investigators

• Sponsor: Providence Medical Technology, Inc.

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: February 15, 2016
• First Submitted That Met QC Criteria: February 23, 2016
• First Posted (Estimate): February 29, 2016

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

• Keywords: fusion; radiculopathy; cervical; DTRAX
• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Radiculopathy
• Other Study ID Numbers: DTRAXCCB-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No