Degenerative Disc DiseaseNCT00443547

Outcome Study of Patients Treated With Translational Cervical Plate Used to Treat Degenerative Disc Disease

An observational study of Degenerative Disc Disease, run by Synthes USA HQ, Inc. at 13 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study is to measure the benefits of anterior (from the front) cervical (neck) surgery for degenerative disc disease. The research part of this study is the answering of questionnaires by the patient concerning their quality of life, prior to, and after surgery. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Degenerative Disc Disease
What is being tested?: Vectra-T
Type of treatment: Medical device
How many people: 231 participants
Where: 13 sitesUnited States
Study dates: 1 Mar 2006to 1 Apr 2011
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Surgeon's personal patient contacts

Who may be able to join

One to four levels (consecutive) cervical degenerative disc disease between C2 and C7, defined as at least one of the following:
disc herniation
axial neck pain (with or without radiculopathy or myelopathy) caused by spondylosis
functional deficit
neurological deficit which significantly limits patient's normal living
One to four cervical levels to be plated

Show all 10Show fewer

Patient is skeletally mature and at least 18 years of age
Patient signs consent form
Patient is available for long term (24 month) follow-up
Etiology must be confirmed by MRI or CT

Who cannot join

Spondylolisthesis greater than grade 1 at either level(s) to be instrumented
Indications for complete corpectomy of any involved levels
Posterior instrumentation is necessary at same levels
More than one previous failed anterior fusion attempt at the involved level(s)
Has had more than one previous open, posterior, spine surgical procedures at the involved level(s) or pre-op instability on Flexion/Extension radiographs.
Pregnant or interested in becoming pregnant during the study follow-up period

Show all 10Show fewer

Has a known sensitivity to device materials
Mentally incompetent or prisoner
Currently a participant in a study related to the treatment of cervical spinal disorders
Pre-op instability>3mm on flexion/extension X-rays

Trial locations and contacts

13 sites in 1 country.

City, postcode or hospital

13 sites in 1 country

United States13 sites

Roderick Sanden, MD
Carmichael, California, 95608
Abhay Varma, MD
Charleston, South Carolina, 29425
Faheem Sandhu, MD
Clinton, Maryland, 20735
John Moriarity, MD
Flowood, Mississippi, 39232
Mark Crawford, MD
Fort Wayne, Indiana, 46804
Chris Urban, MD
Glen Burnie, Maryland, 21061
Jamal Taha, MD
Kettering, Ohio, 45429
Yu-Po Lee, MD
La Jolla, California, 92093-0706
Ardavan Aslie, MD
Marysville, California, 95901
Dennis Maiman, MD
Milwaukee, Wisconsin, 53226
Don Kovalsky, MD
Mount Vernon, Illinois, 62864
Barry Chehrazi, MD
Roseville, California, 95661
Daniel Nehls, MD
Tacoma, Washington, 98405

Other trials in United States

About this study

Official title: Prospective Multi-Center Clinical Study of Patients With Degenerative Disc Disease Treated With Anterior Cervical Decompression and Fusion Using the Vectra-T Translational Cervical Plate.

Read the detailed description

This is a prospective, multi-center, four-arm study designed to evaluate the clinical and radiographic outcomes in patients diagnosed with cervical degenerative disc disease (DDD) and treated using the Vectra-T Cervical Plate and the Advanced ACF or CorticoCancellous Allograft Spacer made by Synthes Spine Company (Paoli, PA). This is not an investigational study (IDE) and no investigational or experimental devices or procedures are included in this study.

Conditions: Degenerative Disc Disease
Being tested: Vectra-T
Keywords: Prospective, Degenerative Disc Disease, Cervical, Translational Plate
Medical subject headings: Intervertebral Disc Degeneration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Vectra-TDevice
Also called Vectra-T Translational Plating System
Patient will receive the Vectra-T plate (Sized 1 to 4 levels)

Study groups in NCT00443547
Study group	Role	What they receive
1-level		Patients needing a single level cervical fusion with Vectra-T Receives: Device: Vectra-T
2-level		Patients needing cervical fusion at two consecutive levels with Vectra-T Receives: Device: Vectra-T
3-level		Patients needing cervical fusion at three consecutive levels with Vectra-T Receives: Device: Vectra-T
4-level		Patients needing cervical fusion at four consecutive levels with Vectra-T Receives: Device: Vectra-T

What is being measured

The primary outcome is the main question the study is designed to answer.

Radiographic Fusion
Percentage of subjects who were successfully fused per an independent radiographic assessment at all index levels
Measured: 24 Months
Radiographic Fusion
Percentage of subjects who were successfully fused per an independent radiographic assessment at all index levels
Measured: 12 Months

Secondary outcomes (1)

Neck Disability Index (NDI) is a Widely Used Instrument for Assessing Self-reported Disability in Patients With Neck Pain. Scoring is Reported on a 0-100 Point Scale, 0 Being the Best Possible Score and 100 Being the Worst Possible Score
Average NDI score at 24 months - score range is 0 to 100, with 0 being the best and 100 being the worst
Measured: 24 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Mar 20061 Apr 2011

First posted6 Mar 2007 (estimated)
Study start1 Mar 2006
Primary completion1 Apr 2011
Study completion1 Apr 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Degenerative Disc DiseaseStudies 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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 231 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00443547
Sponsor's protocol ID: VECTR 1492
Status last verified: Jun 2019
First submitted: 2 Mar 2007
Last updated: 29 Jul 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Post Marketing Study of MagnetOs Easypack Putty Standalone Compared to Demineralized Bone Matrix or Fibers Mixed With Autograft in Patients Undergoing Posterolateral Lumbar Fusion
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Relationship Between Disability, Flexibility, Back Muscles, and Thoracolumbar Fascia in Patients With Lumbar Disc Degeneration
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ASCEND: A Clinical Trial to Evaluate the Safety and Effectiveness of VIA Disc NP, a Supplement for Degenerated Intervertebral Discs
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Active, not recruiting
The Synergy Disc for the Treatment of 2 Level Cervical Degenerative Disc Disease Compared With Cervical Fusion Surgery
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All Degenerative Disc Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prospective Multi-Center Clinical Study of Patients With Degenerative Disc Disease Treated With Anterior Cervical Decompression and Fusion Using the Vectra-T Translational Cervical Plate.
ClinicalTrials.gov ID: NCT00443547
Acronym / sponsor ID: VECTR 1492
Conditions: Degenerative Disc Disease
Keywords: Prospective, Degenerative Disc Disease, Cervical, Translational Plate
Study type: Observational
Recruitment status: Completed
Enrolment: 231 participants (actual)
Lead sponsor: Synthes USA HQ, Inc.Industry (pharma, biotech, devices)
Study start: 1 Mar 2006 (actual)
Primary completion: 1 Apr 2011 (actual)
Study completion: 1 Apr 2011 (actual)
First posted: 6 Mar 2007 (estimated)
Results: Posted 29 Jul 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 4

Arm	Type	Receives
1-level	–	Device: Vectra-TPatients needing a single level cervical fusion with Vectra-T
2-level	–	Device: Vectra-TPatients needing cervical fusion at two consecutive levels with Vectra-T
3-level	–	Device: Vectra-TPatients needing cervical fusion at three consecutive levels with Vectra-T
4-level	–	Device: Vectra-TPatients needing cervical fusion at four consecutive levels with Vectra-T

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Surgeon's personal patient contacts

Key inclusion criteria (10 listed)

One to four levels (consecutive) cervical degenerative disc disease between C2 and C7, defined as at least one of the following:
One to four cervical levels to be plated
Patient is skeletally mature and at least 18 years of age
Patient signs consent form
Patient is available for long term (24 month) follow-up

Key exclusion criteria (10 listed)

Spondylolisthesis greater than grade 1 at either level(s) to be instrumented
Indications for complete corpectomy of any involved levels
Posterior instrumentation is necessary at same levels
More than one previous failed anterior fusion attempt at the involved level(s)
Has had more than one previous open, posterior, spine surgical procedures at the involved level(s) or pre-op instability on Flexion/Extension radiographs.

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
Vectra-TAlso: Vectra-T Translational Plating SystemPatient will receive the Vectra-T plate (Sized 1 to 4 levels)	Device	1-level, 2-level, 3-level, 4-level

Primary outcome

Radiographic Fusion
Time frame: 24 Months
Percentage of subjects who were successfully fused per an independent radiographic assessment at all index levels
Radiographic Fusion
Time frame: 12 Months
Percentage of subjects who were successfully fused per an independent radiographic assessment at all index levels

1 secondary outcome

Neck Disability Index (NDI) is a Widely Used Instrument for Assessing Self-reported Disability in Patients With Neck Pain. Scoring is Reported on a 0-100 Point Scale, 0 Being the Best Possible Score and 100 Being the Worst Possible Score
Time frame: 24 Months

Results and safety

Results posted to the registry on 29 Jul 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
1-level	89	44
2-level	88	46
3-level	48	27
4-level	6	4

Primary outcome: Radiographic Fusion

Time frame: 24 Months. Number. Unit: percentage of subjects

Measure	1-level n = 44	2-level n = 46	3-level n = 27	4-level n = 4
Value	66	46	37	75

Population analysed: Number of subjects present for the 24 month visit

Primary outcome: Radiographic Fusion

Time frame: 12 Months. Number. Unit: percentage of subjects

Measure	1-level n = 58	2-level n = 55	3-level n = 37	4-level n = 5
Value	48	25	27	20

Population analysed: Number of subjects present for the 12 month visit

1 secondary outcome is reported in the full results.

Adverse events

Time frame: From enrollment through 24 months. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
1-level	3 of 89 (3.4%)	8 of 89 (9%)	Not reported
2-level	1 of 88 (1.1%)	13 of 88 (14.8%)	Not reported
3-level	0 of 48 (0%)	5 of 48 (10.4%)	Not reported
4-level	0 of 6 (0%)	2 of 6 (33.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Degenerative Disc Disease

Not yet recruiting
CANLINK: Evaluation of the Intralink Intradiscal Device for Low Back Pain Due to Degenerative Disc Disease
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Active, not recruiting
Post Marketing Study of MagnetOs Easypack Putty Standalone Compared to Demineralized Bone Matrix or Fibers Mixed With Autograft in Patients Undergoing Posterolateral Lumbar Fusion
Degenerative Disc Disease, Spine Fusion
Not yet recruitingObservational study
Relationship Between Disability, Flexibility, Back Muscles, and Thoracolumbar Fascia in Patients With Lumbar Disc Degeneration
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Active, not recruiting
ASCEND: A Clinical Trial to Evaluate the Safety and Effectiveness of VIA Disc NP, a Supplement for Degenerated Intervertebral Discs
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Active, not recruiting
The Synergy Disc for the Treatment of 2 Level Cervical Degenerative Disc Disease Compared With Cervical Fusion Surgery
Cervical Degenerative Disc Disease

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.

Donald Kovalsky, M.D. principal investigator

13 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Degenerative Disc Disease, run by Synthes USA HQ, Inc. at 13 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 10 inclusion and 10 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: finished, as of the sponsor's last update on 29 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 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?

Yes. Results are posted in the registry (first posted 29 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Radiographic Fusion (time frame: 24 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00443547.

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 29 Jul 2019.