NCT01616719

Brief Summary

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started May 2012

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 7, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 12, 2012

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

March 4, 2020

Status Verified

March 1, 2020

Enrollment Period

1.8 years

First QC Date

June 7, 2012

Last Update Submit

March 2, 2020

Conditions

Cervical SpondylosisCervical RadiculopathyCervical Degenerative Disc Disease

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Safety information will be evaluated by collecting the type, frequency, severity, device, and procedure-relatedness of adverse events.

    Baseline throughout 12 months post-operatively

Study Arms (1)

DTRAX graft

OTHER
Device: DTRAX Graft

Interventions

DTRAX GraftDEVICE

DTRAX Graft is an allograft implant inserted to support spinal fusion.

DTRAX graft

Eligibility Criteria

Age35 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • 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.
  • Subject has dynamic stenosis relieved by traction and made worse by a Spurlings maneuver.
  • +9 more criteria

You may not qualify if:

  • 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.
  • Subject has overt or active spinal and/or systemic infection.
  • Subject has 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.
  • 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.
  • Subject has fever at the time of surgery, defined as \> 38.5 degrees C.
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Office of Dr. Brian Andrews, Neurosurgery

San Francisco, California, 94114, United States

Location

Neurospine Institute Medical Group

San Francisco, California, 94115, United States

Location

MeSH Terms

Conditions

SpondylosisRadiculopathy

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal DiseasesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System Diseases

Study Officials

  • Bruce McCormack, M.D.

    Neurospine Institute Medical Group

    PRINCIPAL INVESTIGATOR

  • Brian Andrews, M.D.

    Office of Dr. Brian Andrews, Neurosurgery

    PRINCIPAL INVESTIGATOR
0

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

June 7, 2012

First Posted

June 12, 2012

Study Start

May 1, 2012

Primary Completion

February 1, 2014

Study Completion

February 1, 2015

Last Updated

March 4, 2020

Record last verified: 2020-03

Locations

US(2)