Cervical RadiculopathyNCT02694250
Evaluation of Cervical Fusion With DTRAX® Cervical Cage With DTRAX Bone Screw
A study testing DTRAX® Cervical Cage with DTRAX Bone Screw in people with Cervical Radiculopathy, run by Providence Medical Technology, Inc. at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- Cervical Radiculopathy
- What is being tested?
- DTRAX® Cervical Cage with DTRAX Bone Screw
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 7 sitesUnited States
- Study dates
- Nov 2015to Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject diagnosed with one level cervical spondylosis with radiculopathy in C3-C7, defined as follows:
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
- Subject has documented allergy or intolerance to stainless steel, titanium, or a titanium alloy.
- 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.
- Subject has history of an endocrine or metabolic disorder known to affect osteogenesis.
- 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.
- Subject is involved in or planning spinal litigation or Workmen's Compensation claim.
- Subject is morbidly obese, defined as body mass index (BMI) > 40.
- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Cary Orthopaedic Spine Specialists
Cary, North Carolina, 27518
Daytona Orthopaedic and Spinal Research Group
Daytona Beach, Florida, 32117
Upstate Orthopedics
East Syracuse, New York, 13057
Southern New York NeuroSurgical Group, P.C.
Johnson City, New York, 13790
Louisiana State University Health Sciences Center - New Orleans (LSUHSC - NO)
New Orleans, Louisiana, 70112
Neurospine Institute Medical Group
San Francisco, California, 94115
Foundation for Orthopaedic Research and Education
Tampa, Florida, 33637
About this study
Official title: 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.
- Conditions
- Cervical Radiculopathy
- Being tested
- DTRAX® Cervical Cage with DTRAX Bone Screw
- Keywords
- cervical, fusion, radiculopathy, DTRAX
- Medical subject headings
- Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DTRAX® Cervical Cage with DTRAX Bone ScrewDevice
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. .
| Study group | Role | What they receive |
|---|---|---|
| DTRAX Cervical Cervical Cage with DTRAX Bone Screw | Other | Not described Receives: Device: DTRAX® Cervical Cage with DTRAX Bone Screw |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline throughout 24 months post-operatively
Secondary outcomes (4)
Assess the clinical outcome data based Neck Disability Index (NDI)
Measured: Baseline throughout 24 months post-operatively
Assess the clinical outcome data based SF-12 v2 Health Survey
Measured: Baseline throughout 24 months post-operatively
Assess the clinical outcome data based the Visual Analogue Scale (Neck and Arm VAS)
Measured: 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
Measured: Baseline throughout 24 months post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2016 (estimated)
- Study startNov 2015
- Primary completionSep 2016
- Study completionSep 2016
Why it stopped: study not started due to lack of resources
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical RadiculopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Providence Medical Technology, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02694250
- Sponsor's protocol ID
- DTRAXCCB-001
- Status last verified
- Mar 2020
- First submitted
- 15 Feb 2016
- Last updated
- 4 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Cervical Fusion With DTRAX® Cervical Cage With DTRAX Bone Screw in Patients With Cervical Radiculopathy
- ClinicalTrials.gov ID
- NCT02694250
- Acronym / sponsor ID
- DTRAXCCB-001
- Conditions
- Cervical Radiculopathy
- Keywords
- cervical, fusion, radiculopathy, DTRAX
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: study not started due to lack of resources
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Providence Medical Technology, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2015
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 29 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DTRAX Cervical Cervical Cage with DTRAX Bone Screw | Other | Device: DTRAX® Cervical Cage with DTRAX Bone Screw |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Subject diagnosed with one level cervical spondylosis with radiculopathy in C3-C7, defined as follows:
- 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.
Key exclusion criteria (22 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DTRAX® Cervical Cage with DTRAX Bone ScrewDTRAX 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. . | Device | DTRAX Cervical Cervical Cage with DTRAX Bone Screw |
Primary outcome
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
4 secondary outcomes
Assess the clinical outcome data based Neck Disability Index (NDI)
Time frame: Baseline throughout 24 months post-operatively
Assess the clinical outcome data based SF-12 v2 Health Survey
Time frame: Baseline throughout 24 months post-operatively
Assess the clinical outcome data based the Visual Analogue Scale (Neck and Arm VAS)
Time frame: 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
Time frame: Baseline throughout 24 months post-operatively
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DTRAX® Cervical Cage with DTRAX Bone Screw in people with Cervical Radiculopathy, run by Providence Medical Technology, Inc. at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 4 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2020.