Herniated DiscNCT00585923

Slotted Hole Versus Fixed Hole C-Tek

A study testing Fixed hole C-Tek™ Plate and Slotted hole C-Tek™ Plate in people with Herniated Disc and Radiculopathy, run by Zimmer Biomet at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The purpose of this study is to compare the fusion rates between the EBI, LLC C-Tek™ Anterior Cervical Plate, Slotted Hole Design versus the Fixed Hole Design. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Herniated Disc, Radiculopathy, Spondylolysis
What is being tested?: Fixed hole C-Tek™ Plate and Slotted hole C-Tek™ Plate
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 115 participants
Where: 1 siteUnited States
Study dates: Apr 2002to May 2008
Phase: Interventional
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 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Radiographic evidence of compressed cervical roots or cord by either ossified bony elements or herniated nucleus pulposus.
Symptomatic radiculopathy appropriate to compressed nerve root.
Cervical spondylosis as evidenced by reactive changes in the vertebral bodies about the interspace, and may be associated with chronic discopathy.
Primary anterior cervical spinal fusion (ACDF) performed using an anterior cervical plate and either a discectomy (Smith-Robinson technique) or a Corpectomy.
Adult male or female, 18 to 75 years of age.
The subject or his/her legal guardian is willing to consent to participate in this study.
The subject will be available for follow-up for a minimum of 24 months.

Who cannot join

Traumatic cervical injury.
Posterior augmentation or revision fusion.
Cervical fusion involving C1 and C2 vertebrae.
Cervical fusion involving more than three levels.
Previous spine surgery at the same levels as those that will be fixed with the C-Tek plate.
Systemic conditions: Spondylitis, Paget's disease, Rheumatoid arthritis, Infection within two weeks before surgery, Cancer, Renal disease or insufficiency with creatinine level above 2, Chronic use of steroids or other conditions that may affect bone metabolism

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Subjects who are pregnant, nursing or plan to be pregnant within the next 24 months.
Mental or physical conditions that may preclude compliance with physician instruction or the study protocol.
Subjects who require non-steroidal medications chronically for other conditions.
Subject declines to cooperate with the follow-up schedule.
Subject or legal guardian refuses or is unable to sign the informed consent.

Trial locations and contacts

1 site in 1 country.

United States1 site

Spine Institute of Louisiana
Shreveport, Louisiana, 71101

Other trials in United States

About this study

Official title: A Multi-Center Clinical Investigation of Slotted Hole Versus Fixed Hole C-Tek™ Anterior Cervical Plates

The purpose of this study is to compare the fusion rates between the EBI, LLC C-Tek™ Anterior Cervical Plate, Slotted Hole Design versus the Fixed Hole Design.

Read the detailed description

This study's purpose is to compare the fusion rates between the EBI, LLC C-Tek™ Anterior Cervical Plate, Slotted Hole Design versus the Fixed Hole Design

Conditions: Herniated Disc, Radiculopathy, Spondylolysis
Being tested: Fixed hole C-Tek™ Plate, Slotted hole C-Tek™ Plate
Medical subject headings: Intervertebral Disc Displacement, Radiculopathy, Spondylolysis

What participants receive

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

Fixed hole C-Tek™ PlateDevice
Fixed hole C-Tek™ Plate
Slotted hole C-Tek™ PlateDevice
Slotted hole C-Tek™ Plate

Study groups in NCT00585923
Study group	Role	What they receive
Usage of Fixed hole C-Tek™ Plate	Active comparator	Fixed Hole Plate - The fixed hole plate means that the screws do not move, restricting motion and providing additional stability Receives: Device: Fixed hole C-Tek™ Plate
Usage of Slotted hole C-Tek™ Plate	Active comparator	Slotted Hole Plate - Bone screw translates while plate is stationary, which ultimately promotes grafts settling through load sharing. Receives: Device: Slotted hole C-Tek™ Plate

What is being measured

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

Fusion Success
The fusion criteria will include radiographic evidence of no motion at the affected levels on flexion/extension and evidence of bony bridging and no lucent lines on AP/lateral views.
Fusion Grading
"fused" "probably fused" "pseudarthrosis"
This determination was made by Dr. Nunley and there was never any more specific details given on how the determination was made between fused and probably fused.
Measured: Last Follow-Up (Last follow-up ranged from no visit after surgery to 24 months of follow-up)

Secondary outcomes (4)

Pain at Rest
Pain is calculated by patient making an X on a visual analog scale (VAS) line at each visit. Mark on x is measured via a mm ruler. Number of Participants with the Level of Pain at Rest Improved, Maintained or Worsened from Baseline to "last follow-up visit". This is calculated by subtracting the pain at the last follow-up from the pain at the baseline visit. Best Case is 0 and worst case is 100.
Measured: Baseline and Last Follow-Up visit (Last follow-up ranged from no visit after surgery to 24 months of follow-up)
Pain With Activity
Pain is calculated by patient making an X on a visual analog scale (VAS) line at each visit. Mark on x is measured via a mm ruler. Number of Participants with the Level of Pain with Activity Improved, Maintained or Worsened from Baseline to "last follow-up visit". This is calculated by subtracting the pain at the last follow-up from the pain at the baseline visit. Scores range from 0 to 100 with 0 being the best score.
Measured: Baseline and Last follow-up visit (Last follow-up ranged from no visit after surgery to 24 months of follow-up)
Neurological Status Change in Neurological Status Since Surgery.
Patients were categorized as maintained, improved or decreased Neurological Status. This was assessed pre-operatively and at each follow-up visit but reported on last follow-up. Motor Function was measured at each cervical level Reflex Function (0: Not elicitable; 1: Elicited with reinforcement; 2: Normal; 3:Brisk; 4:Clonus, unsustained; 5: Clonus, sustained) was measured for Bicep, Brachioradialis, and Triceps Sensory Function (0: Sensation is absent; 1: Sensating is diminished; 2: Sensation is normal; 3: Sensation is present, but pathological, was measured at each cervical dermatome
Measured: Baseline and Last follow-up visit (Last follow-up ranged from no visit after surgery to 24 months of follow-up)
Level of Function (Neck Disability Index)
Number of patients who have an improved, maintained or decreased level of function based on the results of their NDI (Neck Disabillity Index) from surgery to last follow-up visit. The NDI scale ranges from 0-100. If a subject has a score of 0, it means that they have no limitations and no pain. This is calculated by subtracting the NDI at the last follow-up from the NDI at the baseline visit.
Measured: Baseline and Last follow-up visit (Last follow-up ranged from no visit after surgery to 24 months of follow-up)

Timeline

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

Apr 2002May 2008

First posted4 Jan 2008 (estimated)
Study startApr 2002
Primary completionMay 2008
Study completionMay 2008

Why it stopped: Due to lack of follow-up information

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 Herniated DiscStudies of the same condition, open and under way.
More trials run by Zimmer BiometThe sponsor's other registered studies.
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: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 115 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00585923
Sponsor's protocol ID: CS-014
Status last verified: Feb 2019
First submitted: 21 Dec 2007
Last updated: 5 Mar 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Undecided

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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All Herniated Disc trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-Center Clinical Investigation of Slotted Hole Versus Fixed Hole C-Tek™ Anterior Cervical Plates
ClinicalTrials.gov ID: NCT00585923
Acronym / sponsor ID: CS-014
Conditions: Herniated Disc, Radiculopathy, Spondylolysis
Study type: Interventional
Recruitment status: TerminatedReason stopped: Due to lack of follow-up information
Enrolment: 115 participants (actual)
Lead sponsor: Zimmer BiometIndustry (pharma, biotech, devices)
Study start: Apr 2002
Primary completion: May 2008 (actual)
Study completion: May 2008 (actual)
First posted: 4 Jan 2008 (estimated)
Results: Posted 26 Mar 2010

Clinical summary

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

The purpose of this study is to compare the fusion rates between the EBI, LLC C-Tek™ Anterior Cervical Plate, Slotted Hole Design versus the Fixed Hole Design.

Detailed description

This study's purpose is to compare the fusion rates between the EBI, LLC C-Tek™ Anterior Cervical Plate, Slotted Hole Design versus the Fixed Hole Design

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Usage of Fixed hole C-Tek™ Plate	Active comparator	Device: Fixed hole C-Tek™ PlateFixed Hole Plate - The fixed hole plate means that the screws do not move, restricting motion and providing additional stability
Usage of Slotted hole C-Tek™ Plate	Active comparator	Device: Slotted hole C-Tek™ PlateSlotted Hole Plate - Bone screw translates while plate is stationary, which ultimately promotes grafts settling through load sharing.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Radiographic evidence of compressed cervical roots or cord by either ossified bony elements or herniated nucleus pulposus.
Symptomatic radiculopathy appropriate to compressed nerve root.
Cervical spondylosis as evidenced by reactive changes in the vertebral bodies about the interspace, and may be associated with chronic discopathy.
Primary anterior cervical spinal fusion (ACDF) performed using an anterior cervical plate and either a discectomy (Smith-Robinson technique) or a Corpectomy.
Adult male or female, 18 to 75 years of age.

Key exclusion criteria (11 listed)

Traumatic cervical injury.
Posterior augmentation or revision fusion.
Cervical fusion involving C1 and C2 vertebrae.
Cervical fusion involving more than three levels.
Previous spine surgery at the same levels as those that will be fixed with the C-Tek plate.

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
Fixed hole C-Tek™ PlateFixed hole C-Tek™ Plate	Device	Usage of Fixed hole C-Tek™ Plate
Slotted hole C-Tek™ PlateSlotted hole C-Tek™ Plate	Device	Usage of Slotted hole C-Tek™ Plate

Primary outcome

Fusion Success
Time frame: Last Follow-Up (Last follow-up ranged from no visit after surgery to 24 months of follow-up)
The fusion criteria will include radiographic evidence of no motion at the affected levels on flexion/extension and evidence of bony bridging and no lucent lines on AP/lateral views. Fusion Grading "fused" "probably fused" "pseudarthrosis" This determination was made by Dr. Nunley and there was never any more specific details given on how the determination was made between fused and probably fused.

4 secondary outcomes

Pain at Rest
Time frame: Baseline and Last Follow-Up visit (Last follow-up ranged from no visit after surgery to 24 months of follow-up)
Pain With Activity
Time frame: Baseline and Last follow-up visit (Last follow-up ranged from no visit after surgery to 24 months of follow-up)
Neurological Status Change in Neurological Status Since Surgery.
Time frame: Baseline and Last follow-up visit (Last follow-up ranged from no visit after surgery to 24 months of follow-up)
Level of Function (Neck Disability Index)
Time frame: Baseline and Last follow-up visit (Last follow-up ranged from no visit after surgery to 24 months of follow-up)

Results and safety

Results posted to the registry on 26 Mar 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Fixed Hole C-Tek Plate	56	25
Slotted Hole C-Tek Plate	59	26

Primary outcome: Fusion Success

Time frame: Last Follow-Up (Last follow-up ranged from no visit after surgery to 24 months of follow-up). Number. Unit: participants

Measure	Fixed Hole C-Tek Plate n = 56	Slotted Hole C-Tek Plate n = 59
Solid Fused	27	29
Probably Fused	15	22
Pseudarthrosis (Failed Fusion)	5	0
No Fusion Result	9	8

Population analysed: Fusion Status is shown for the last office visit which the patient attended before the doctor withdrew from the study

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data was collected through the 24 mnth visit. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Fixed Hole C-Tek Plate	2 of 56 (3.6%)	1 of 56 (1.8%)	Not reported
Slotted Hole C-Tek Plate	0 of 59 (0%)	0 of 59 (0%)	Not reported

Limitations and caveats (from the sponsor): Early termination of this study because the doctor involved in the study decided that he did not want to participate in the study any more. The site also did not have very good follow-up on all of their patients

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided

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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.

Joel Batts study director

Biomet Spine

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

Questions about this trial

What is this clinical trial studying?

A study testing Fixed hole C-Tek™ Plate and Slotted hole C-Tek™ Plate in people with Herniated Disc and Radiculopathy, run by Zimmer Biomet at 1 site 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 7 inclusion and 11 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: stopped early, as of the sponsor's last update on 5 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 26 Mar 2010). 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?

Fusion Success (time frame: Last Follow-Up (Last follow-up ranged from no visit after surgery to 24 months of follow-up)). 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 NCT00585923.

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 5 Mar 2019.