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Trial record 11 of 53 for:    cervical radiculopathy

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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Providence Medical Technology, Inc.
ClinicalTrials.gov Identifier:
NCT02694250
First received: February 15, 2016
Last updated: October 14, 2016
Last verified: October 2016
  Purpose
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.

Condition Intervention
Cervical Radiculopathy
Device: DTRAX® Cervical Cage with DTRAX Bone Screw

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Cervical Fusion With DTRAX® Cervical Cage With DTRAX Bone Screw in Patients With Cervical Radiculopathy

Further study details as provided by Providence Medical Technology, Inc.:

Primary Outcome Measures:
  • 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 [ Time Frame: Baseline throughout 24 months post-operatively ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assess the clinical outcome data based Neck Disability Index (NDI) [ Time Frame: Baseline throughout 24 months post-operatively ] [ Designated as safety issue: No ]
  • Assess the clinical outcome data based SF-12 v2 Health Survey [ Time Frame: Baseline throughout 24 months post-operatively ] [ Designated as safety issue: No ]
  • Assess the clinical outcome data based the Visual Analogue Scale (Neck and Arm VAS) [ Time Frame: Baseline throughout 24 months post-operatively ] [ Designated as safety issue: No ]
  • Safety information will be evaluated by collecting the type, frequency, severity, and device and procedure-relatedness of adverse events [ Time Frame: Baseline throughout 24 months post-operatively ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: November 2015
Study Completion Date: September 2016
Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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. .

  Eligibility

Ages Eligible for Study:   35 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02694250

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

Responsible Party: Providence Medical Technology, Inc.
ClinicalTrials.gov Identifier: NCT02694250     History of Changes
Other Study ID Numbers: DTRAXCCB-001 
Study First Received: February 15, 2016
Last Updated: October 14, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Providence Medical Technology, Inc.:
cervical
fusion
radiculopathy
DTRAX

Additional relevant MeSH terms:
Radiculopathy
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on December 02, 2016