Cervical SpondylosisNCT01616719
Evaluation of DTRAX Graft in Patients With Cervical Degenerative Disc Disease
A study testing DTRAX Graft in people with Cervical Spondylosis and Cervical Radiculopathy, run by Providence Medical Technology, Inc. at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- Cervical Spondylosis, Cervical Radiculopathy, Cervical Degenerative Disc Disease
- What is being tested?
- DTRAX Graft
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2012to Feb 2015
- 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 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):
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- 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.
- Subject is 35-80 years of age, inclusive.
- Subject is unresponsive to 6 weeks conservative, nonoperative treatment, or has the presence of progressive symptoms or signs of nerve root compression in face of combined nonoperative management.
- Preoperative NDI score of ≥ 30.
- Preoperative neck pain and arm pain score of ≥ 6 on Neck and Arm Pain Scales.
- Patient is a male or non-pregnant, non-lactating female.
- Female patients of child-bearing potential, including those who have had a tubal ligation, but excluding those who have not experienced a menstrual period for at least two years, must have a negative urine pregnancy test at Screening.
- Patient must 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
- 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.
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- 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.
- Subject has documented allergy or intolerance to stainless steel, titanium, or a titanium alloy.
- Subject has received drugs which may interfere with bone metabolism within two weeks prior to the planned date of DTRAX 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 DTRAX surgery or such treatment is planned during the 16 weeks following implantation of DTRAX Graft.
- Subject is involved in spinal litigation or Workmen's Compensation claim.
- Subject is obese, defined as body mass index (BMI) > 35.
- Patient has psychiatric history, head injury or any other condition, which, in the Investigator's opinion, would prevent the patient from complying with postoperative follow-up visits.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Office of Dr. Brian Andrews, Neurosurgery
San Francisco, California, 94114
Neurospine Institute Medical Group
San Francisco, California, 94115
About this study
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.
- Being tested
- DTRAX Graft
- Medical subject headings
- Spondylosis, Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DTRAX GraftDevice
DTRAX Graft is an allograft implant inserted to support spinal fusion.
| Study group | Role | What they receive |
|---|---|---|
| DTRAX graft | Other | Not described Receives: Device: DTRAX Graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline throughout 12 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 posted12 Jun 2012 (estimated)
- Study startMay 2012 (estimated)
- Primary completionFeb 2014 (estimated)
- Study completionFeb 2015 (estimated)
Why it stopped: study was never 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 SpondylosisStudies 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
- Investigators
- Bruce McCormack, M.D., Principal investigator, Neurospine Institute Medical GroupBrian Andrews, M.D., Principal investigator, Office of Dr. Brian Andrews, Neurosurgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01616719
- Sponsor's protocol ID
- PMT002
- Status last verified
- Mar 2020
- First submitted
- 7 Jun 2012
- Last updated
- 4 Mar 2020
- Results posted
- 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 DTRAX Graft in Patients With Cervical Degenerative Disc Disease
- ClinicalTrials.gov ID
- NCT01616719
- Acronym / sponsor ID
- PMT002
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: study was never started due to lack of resources
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Providence Medical Technology, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2012 (estimated)
- Primary completion
- Feb 2014 (estimated)
- Study completion
- Feb 2015 (estimated)
- First posted
- 12 Jun 2012 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DTRAX graft | Other | Device: DTRAX Graft |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Subject diagnosed with DDD in C3-C7, defined as follows:
- Subject has single-level disease, OR multi-level disease demonstrated radiographically, and confirmed to be symptomatic by one of the following methods:
- 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 has the presence of progressive symptoms or signs of nerve root compression in face of combined nonoperative management.
Key exclusion criteria (22 listed)
- 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.
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 GraftDTRAX Graft is an allograft implant inserted to support spinal fusion. | Device | DTRAX graft |
Primary outcome
Gather clinical outcome data on DTRAX Graft.
Time frame: Baseline throughout 12 months post-operatively
Clinical outcome data will be collected using the Neck Disability Index (NDI), Visual Analogue Scale (VAS), and a quality of life questionnaire.
1 secondary outcome
Safety information will be evaluated by collecting the type, frequency, severity, device, and procedure-relatedness of adverse events.
Time frame: Baseline throughout 12 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.
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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.
Bruce McCormack, M.D. principal investigator
Neurospine Institute Medical Group
Brian Andrews, M.D. principal investigator
Office of Dr. Brian Andrews, Neurosurgery
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DTRAX Graft in people with Cervical Spondylosis and Cervical Radiculopathy, run by Providence Medical Technology, Inc. at 2 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 24 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 2 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?
Gather clinical outcome data on DTRAX Graft. (time frame: Baseline throughout 12 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.