Symptomatic Cervical Disc DiseasePhase 3NCT00758758

Performance of the Hedrocel(R) Cervical Fusion Device

A Phase 3 study testing Anterior Cervical Discectomy and Fusion in people with Symptomatic Cervical Disc Disease, run by Zimmer Biomet at 13 sites in United States.

Completed

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

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Symptomatic Cervical Disc Disease
What is being tested?: Anterior Cervical Discectomy and Fusion
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 231 participants
Where: 13 sitesUnited States
Study dates: Dec 2001to Jun 2009
Phase: Phase 3
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 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

The patient qualifies for ACDF based upon physical examination and medical history. The patient has single or two adjacent levels(s) symptomatic cervical disc disease (including disc herniation and/or spondylosis) from the C3-C4 disc to the C7-T1 disc with associated radiculopathy and/or myelopathy due to nerve root and/or spinal cord compression due to herniated nucleus pulposus or osteophyte formation on the posterior vertebral endplates. Patients who are candidates for surgery based on radicular symptoms must have at least one month of conservative treatment prior to inclusion in the study.
The patient has no history of previous anterior cervical fusion surgery at the involved levels.
The patient has no history of previous cervical fusion surgery at the adjacent levels.
The patient is willing and able to provide written informed consent.
The patient is likely to complete the required follow-up.

Who cannot join

The patient is mentally compromised (e.g., under treatment for a psychiatric disorder or has senile dementia or Alzheimer's disease), or has evidence of alcohol or other substance abuse for the previous 12 months.
The patient has a neuromuscular disorder that would engender unacceptable risk of instability, implant fixation failure, or complications in postoperative care.
The patient has a diagnosed systemic disease that requires the chronic administration of nonsteroidal anti-inflammatory and steroidal drugs.
The patient has osteopenia to a degree that would contraindicate spinal instrumentation (borderline osteoporosis).
The patient has osteoporosis to a degree that would contraindicate spinal instrumentation.
The patient is unable or unwilling to attend postoperative follow-up visits.

Show all 13Show fewer

The patient has received an investigational drug within the previous six months or an investigational device within the previous 12 months.
The patient has a spinal condition other than Cervical DDD based upon physical examination and medical history.
The patient has an infection site distant from the involved levels that may spread to the involved levels hematogenously.
The patient has insufficient bone stock to fix the component.
The patient has a known sensitivity to metallic implants.
The patient is a prisoner.
The patient has a Body Mass Index (BMI) greater than or equal to 40.

Trial locations and contacts

13 sites in 1 country.

City, postcode or hospital

13 sites in 1 country

United States13 sites

Four East Madison Orthopaedic Associates, PA
Baltimore, Maryland, 21204
Boston Spine Group, LLC
Boston, Massachusetts, 02120
Orthocarolina
Charlotte, North Carolina, 28207
University of Virginia Health System - Department of Neurosurgery
Charlottesville, Virginia, 22908
Orthopaedic Specialties
Clearwater, Florida, 33756
Inova Fairfax Hospital
Fairfax, Virginia, 22031
Fort Wayne Orthopedics
Fort Wayne, Indiana, 46804
Cedars-Sinai Medical Center Institute for Spinal Disorders
Los Angeles, California, 90048
Spine Surgery PSC
Louisville, Kentucky, 40202
Twin Cities Spine Center
Minneapolis, Minnesota, 55404
Howell Allen Clinic
Nashville, Tennessee, 37203
Vanderbilt Orthopedic Institute
Nashville, Tennessee, 37232-8774
Southeastern Clinic Research
Orlando, Florida, 32804

Other trials in United States

About this study

Read the detailed description

The objective of this clinical investigation is to compare patients treated with Anterior Cervical Discectomy and Fusion (ACDF) using the Hedrocel Cervical Fusion Device, with a concurrent, randomized, control group receiving autologous iliac crest bone graft. Success criteria include radiographic evidence of fusion, and improvement in pain, function and overall quality of life. If shown to be successful, the use of the Hedrocel Cervical Fusion Device would eliminate complications associated with harvesting autologous bone graft and provide an alternative for those who are unable to provide autologous bone graft from the iliac crest.

Conditions: Symptomatic Cervical Disc Disease
Being tested: Anterior Cervical Discectomy and Fusion
Keywords: Anterior Cervical Discectomy and Fusion,, Degenerative Disc Disease,, Cervical Spine,, Herniated Disc
Medical subject headings: Intervertebral Disc Degeneration, Intervertebral Disc Displacement

What participants receive

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

Anterior Cervical Discectomy and FusionDevice
Implantation of Hedrocel
Anterior Cervical Discectomy and FusionDevice
Implantation of Allograft
Anterior Cervical Discectomy and FusionDevice
Implantation of Autograft

Study groups in NCT00758758
Study group	Role	What they receive
Experimental Arm 1	Experimental	Hedrocel 1 level - No plate Receives: Device: Anterior Cervical Discectomy and Fusion
Experimental Arm 2	Experimental	Hedrocel 1 level with plate Receives: Device: Anterior Cervical Discectomy and Fusion
Experimental Arm 3	Experimental	Hedrocel 2 levels with plate Receives: Device: Anterior Cervical Discectomy and Fusion
Control Arm 1	Active comparator	Autograft alone - Illiac crest Receives: Device: Anterior Cervical Discectomy and Fusion
Control Arm 2	Active comparator	Autograft 1 level with plate Receives: Device: Anterior Cervical Discectomy and Fusion
Control Arm 3	Active comparator	Allograft 1 level with plate Receives: Device: Anterior Cervical Discectomy and Fusion
Control Arm 4	Active comparator	Autograft 2 levels with plate Receives: Device: Anterior Cervical Discectomy and Fusion
Control Arm 5	Active comparator	Allograft 2 levels with plate Receives: Device: Anterior Cervical Discectomy and Fusion

What is being measured

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

Overall Clinical Success (NDI, Fusion, Additional Surgical Procedures)
Success was defined as an improvement in patient functional capability using the Neck Disability Index (NDI) by at least 10% as compared to the pre-operative evaluation and Radiographic evidence of fusion (< 3mm translation; < 5° angular motion and absence of radiolucent lines around ≥ 50% of the device)and A comparison of the incidence of intraoperative and postoperative complications which resulted in additional surgical procedures of revision, removal or supplemental fixation at 12 months
Measured: 12 Months
Neck Disability Index (NDI)
The Neck Disability Index (NDI) is an instrument used for testing self-rated disability in neck pain patients. The Neck Disability Index (NDI) consists of 10 questions, each with a score up to 5, for a total score of 50. The lower the score, the less self-rated disability.
NDI scoring:
- 0 - 4 = No disability
- 5 - 14 = Mild disability
- 15 - 24 = Moderate disability
- 25 - 34 = Severe disability
- 35 or over = Complete disability
Measured: 12 Months

Timeline

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

Dec 2001Jun 2009

First posted25 Sep 2008 (estimated)
Study startDec 2001
Primary completionJan 2009
Study completionJun 2009

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 Symptomatic Cervical Disc DiseaseStudies 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 231 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00758758
Sponsor's protocol ID: IC 003-99
Status last verified: Aug 2013
First submitted: 23 Sep 2008
Last updated: 23 Aug 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: 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

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
Enrolling by invitationObservational study
Retrospective Analysis of Patients Implanted With 2 Levels of Prodisc® C Vivo Devices
Degenerative Disc Disease, Cervical Spine Degenerative Disease
Not yet recruiting
A Multi-Center, Prospective Historically Controlled Clinical Trial Comparing the Safety and Effectiveness of Triadyme-C to a Total Disc Replacement Control Cohort in the Treatment of Symptomatic Cervical Disc Disease (SCDD) at a Single Level
Cervical Disc Disease
Active, not recruiting
The Synergy Disc To Anterior Cervical Discectomy and Fusion
Cervical Degenerative Disc Disease
Active, not recruiting
2-level Cervical Disc Replacement Comparing Prodisc C SK & Vivo to Mobi-C
Symptomatic Cervical Disc Disease

All Symptomatic Cervical Disc Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Performance of the Hedrocel(R) Cervical Fusion Device
ClinicalTrials.gov ID: NCT00758758
Acronym / sponsor ID: IC 003-99
Conditions: Symptomatic Cervical Disc Disease
Keywords: Anterior Cervical Discectomy and Fusion,, Degenerative Disc Disease,, Cervical Spine,, Herniated Disc
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 231 participants (actual)
Lead sponsor: Zimmer BiometIndustry (pharma, biotech, devices)
Study start: Dec 2001
Primary completion: Jan 2009 (actual)
Study completion: Jun 2009 (actual)
First posted: 25 Sep 2008 (estimated)
Results: Posted 12 Aug 2013

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

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 8

Arm	Type	Receives
Experimental Arm 1	Experimental	Device: Anterior Cervical Discectomy and FusionHedrocel 1 level - No plate
Experimental Arm 2	Experimental	Device: Anterior Cervical Discectomy and FusionHedrocel 1 level with plate
Experimental Arm 3	Experimental	Device: Anterior Cervical Discectomy and FusionHedrocel 2 levels with plate
Control Arm 1	Active comparator	Device: Anterior Cervical Discectomy and FusionAutograft alone - Illiac crest
Control Arm 2	Active comparator	Device: Anterior Cervical Discectomy and FusionAutograft 1 level with plate
Control Arm 3	Active comparator	Device: Anterior Cervical Discectomy and FusionAllograft 1 level with plate
Control Arm 4	Active comparator	Device: Anterior Cervical Discectomy and FusionAutograft 2 levels with plate
Control Arm 5	Active comparator	Device: Anterior Cervical Discectomy and FusionAllograft 2 levels with plate

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

The patient qualifies for ACDF based upon physical examination and medical history. The patient has single or two adjacent levels(s) symptomatic cervical disc disease (including disc herniation and/or spondylosis) from the C3-C4 disc to the C7-T1 disc with associated radiculopathy and/or myelopathy due to nerve root and/or spinal cord compression due to herniated nucleus pulposus or osteophyte formation on the posterior vertebral endplates. Patients who are candidates for surgery based on radicular symptoms must have at least one month of conservative treatment prior to inclusion in the study.
The patient has no history of previous anterior cervical fusion surgery at the involved levels.
The patient has no history of previous cervical fusion surgery at the adjacent levels.
The patient is willing and able to provide written informed consent.
The patient is likely to complete the required follow-up.

Key exclusion criteria (13 listed)

The patient is mentally compromised (e.g., under treatment for a psychiatric disorder or has senile dementia or Alzheimer's disease), or has evidence of alcohol or other substance abuse for the previous 12 months.
The patient has a neuromuscular disorder that would engender unacceptable risk of instability, implant fixation failure, or complications in postoperative care.
The patient has a diagnosed systemic disease that requires the chronic administration of nonsteroidal anti-inflammatory and steroidal drugs.
The patient has osteopenia to a degree that would contraindicate spinal instrumentation (borderline osteoporosis).
The patient has osteoporosis to a degree that would contraindicate spinal instrumentation.

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
Anterior Cervical Discectomy and FusionImplantation of Hedrocel	Device	Experimental Arm 1, Experimental Arm 2, Experimental Arm 3
Anterior Cervical Discectomy and FusionImplantation of Allograft	Device	Control Arm 3, Control Arm 5
Anterior Cervical Discectomy and FusionImplantation of Autograft	Device	Control Arm 1, Control Arm 2, Control Arm 4

Primary outcome

Overall Clinical Success (NDI, Fusion, Additional Surgical Procedures)
Time frame: 12 Months
Success was defined as an improvement in patient functional capability using the Neck Disability Index (NDI) by at least 10% as compared to the pre-operative evaluation and Radiographic evidence of fusion (< 3mm translation; < 5° angular motion and absence of radiolucent lines around ≥ 50% of the device)and A comparison of the incidence of intraoperative and postoperative complications which resulted in additional surgical procedures of revision, removal or supplemental fixation at 12 months
Neck Disability Index (NDI)
Time frame: 12 Months
The Neck Disability Index (NDI) is an instrument used for testing self-rated disability in neck pain patients. The Neck Disability Index (NDI) consists of 10 questions, each with a score up to 5, for a total score of 50. The lower the score, the less self-rated disability. NDI scoring: * 0 - 4 = No disability * 5 - 14 = Mild disability * 15 - 24 = Moderate disability * 25 - 34 = Severe disability * 35 or over = Complete disability

Results and safety

Results posted to the registry on 12 Aug 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Hedrocel 1 Level Without Plate	14	11
Hedrocel 1 Level With Plate	74	49
Hedrocel 2 Levels With Plate	53	35
Autograft Only - Illiac Crest	6	4
Autograft 1 Level With Plate	3	1
Allograft 1 Level With Plate	50	36
Allograft 2 Levels With Plate	31	17
Autograft 2 Levels With Plate	0	0

Primary outcome: Overall Clinical Success (NDI, Fusion, Additional Surgical Procedures)

Time frame: 12 Months. Number. Unit: participants

Measure	1 Level Hedrocel Without Plate n = 11	One Level Hedrocel With Plate n = 49	Two Levels Plated Hedrocel n = 35	Illiac Crest Autograft - no Plate n = 4	Plated Autograft n = 1	Plated Allograft n = 36	2 Levels Plated Autograft n = 0	2 Levels With Plated Allograft n = 17
Value	5	33	28	2	1	22	–	15

Primary outcome: Neck Disability Index (NDI)

Time frame: 12 Months. Mean (Standard Deviation). Unit: units on a scale

Measure	1 Level Hedrocel Without Plate n = 11	Hedrocel With Plate n = 52	2 Levels Hedrocel With Plate n = 39	Illiac Crest Autograft n = 4	Autograft With Plate n = 1	Allograft With Plate n = 40	Autograft With 2 Plates n = 0	Allograft With 2 Plates n = 20
Value	14.82 (14.10)	11.25 (10.30)	8.77 (7.67)	6.25 (8.02)	1 (0)	8.65 (8.56)	–	10 (6.77)

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Hedrocel 1 Level Without Plate	2 of 14 (14.3%)	2 of 14 (14.3%)	Not reported
Hedrocel 1 Level With Plate	2 of 74 (2.7%)	9 of 74 (12.2%)	Not reported
Hedrocel 2 Levels With Plate	1 of 53 (1.9%)	15 of 53 (28.3%)	Not reported
Autograft Only - Illiac Crest	0 of 6 (0%)	0 of 6 (0%)	Not reported
Autograft With Plate	0 of 3 (0%)	0 of 3 (0%)	Not reported
Allograft With Plate	0 of 50 (0%)	5 of 50 (10%)	Not reported
Autograft 2 Levels With Plate	0 of 0	0 of 0	Not reported
Allograft 2 Levels With Plate	1 of 31 (3.2%)	2 of 31 (6.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Symptomatic Cervical Disc Disease

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
Enrolling by invitationObservational study
Retrospective Analysis of Patients Implanted With 2 Levels of Prodisc® C Vivo Devices
Degenerative Disc Disease, Cervical Spine Degenerative Disease
Not yet recruiting
A Multi-Center, Prospective Historically Controlled Clinical Trial Comparing the Safety and Effectiveness of Triadyme-C to a Total Disc Replacement Control Cohort in the Treatment of Symptomatic Cervical Disc Disease (SCDD) at a Single Level
Cervical Disc Disease
Active, not recruiting
The Synergy Disc To Anterior Cervical Discectomy and Fusion
Cervical Degenerative Disc Disease
Active, not recruiting
2-level Cervical Disc Replacement Comparing Prodisc C SK & Vivo to Mobi-C
Symptomatic Cervical 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.

The record lists no contact. Use the official record to reach the sponsor.

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Anterior Cervical Discectomy and Fusion in people with Symptomatic Cervical Disc Disease, run by Zimmer Biomet 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 5 inclusion and 13 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 23 Aug 2013. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Aug 2013). 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?

Overall Clinical Success (NDI, Fusion, Additional Surgical Procedures) (time frame: 12 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 NCT00758758.

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 23 Aug 2013.