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

NCT02694250 | Withdrawn

• 1 other identifier: DTRAXCCB-001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

Cervical Radiculopathy

Keywords

cervical; fusion; radiculopathy; DTRAX

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Study Arms (1)

DTRAX Cervical Cervical Cage with DTRAX Bone Screw

OTHER

Device: DTRAX® Cervical Cage with DTRAX Bone Screw

Interventions

DTRAX® Cervical Cage with DTRAX Bone Screw DEVICE

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. .

DTRAX Cervical Cervical Cage with DTRAX Bone Screw

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• Subject must have the ability to understand and voluntarily provide written, informed consent.
• Subject is able to meet the proposed follow-up schedule.
• Subject is able to follow the postoperative management program.

You may not qualify if:

• Any previous cervical spinal surgery.
• Subject has known osteoporosis, osteomalacia, spinal metastases, or metabolic bone disease OR subject has sustained a vertebral compression or nontraumatic hip or wrist fracture.
• Subject has overt or active spinal and/or systemic infection.
• Subject has cervical spondylolisthesis \> 3.5mm or rotator subluxation.
• Subject has cervical myelopathy.
• Subject has a chronic pain syndrome.
• Subject has radicular findings with major motor impairment.
• 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).
• Subject is mentally incompetent.
• Subject is a prisoner.
• Subject is pregnant.
• Subject abuses alcohol or drugs.
• Subject has a cervical spinal condition other than symptomatic cervical disc disease requiring surgical treatment at the involved level.
• Subject has insulin dependent diabetes.
• Subject has chronic or acute renal failure or prior history of renal disease.

Sponsors & Collaborators

• Providence Medical Technology, Inc.: lead

Study Sites (7)

Neurospine Institute Medical Group

San Francisco, California, 94115, United States

Location

Daytona Orthopaedic and Spinal Research Group

Daytona Beach, Florida, 32117, United States

Location

Foundation for Orthopaedic Research and Education

Tampa, Florida, 33637, United States

Location

Louisiana State University Health Sciences Center - New Orleans (LSUHSC - NO)

New Orleans, Louisiana, 70112, United States

Location

Upstate Orthopedics

East Syracuse, New York, 13057, United States

Location

Southern New York NeuroSurgical Group, P.C.

Johnson City, New York, 13790, United States

Location

Cary Orthopaedic Spine Specialists

Cary, North Carolina, 27518, United States

Location

MeSH Terms

Conditions

Radiculopathy

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2016
• First Posted: February 29, 2016
• Study Start: November 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: March 4, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)