RadiculopathyPhase 3NCT01905930
Post-Approval Clinical Trial of the PCM® Cervical Disc
A Phase 3 study testing PCM Cervical Disc and Anterior Cervical Discectomy and Fusion (ACDF) in people with Radiculopathy and Myelopathy, run by NuVasive at 18 sites in United States.
Trial summary
On October 26, 2012, the FDA granted Premarket Approval (PMA) for the PCM Cervical Disc. PCM Cervical Disc is indicated for use in skeletally mature patients for reconstruction of a degenerated cervical disc at one level from C3-C4 to C6-C7 following single-level discectomy for intractable radiculopathy (arm pain… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Radiculopathy, Myelopathy
- What is being tested?
- PCM Cervical Disc and Anterior Cervical Discectomy and Fusion (ACDF)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 494 participants
- Where
- 18 sitesUnited States
- Study dates
- Apr 2013to Apr 2015
- Phase
- Phase 3
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients enrolled in the PCM Cervical Disc IDE clinical study
- Patients willing and able to give informed consent
Who cannot join
- Patients considered failure during the PCM Cervical Disc IDE clinical study
- Patients who were withdrawn during the PCM Cervical Disc IDE clinical study
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
NeuroSpine Center of Wisconsin
Appleton, Wisconsin, 54913
Spine Group Beverly Hills
Beverly Hills, California, 90212
Midwest Orthopedic Associates at Rush
Chicago, Illinois, 60612
Chicago Back Institute
Chicago, Illinois, 60625
The Cleveland Clinic
Cleveland, Ohio, 44195
Columbia Orthopedic Research
Columbia, Missouri, 65201
Denver Spine
Greenwood Village, Colorado, 80111
Goodman Campbell Brain and Spine
Indianapolis, Indiana, 46260
Buffalo Spine Surgery
Lockport, New York, 14094
Neuroscience Specialists
Oklahoma City, Oklahoma, 73120
Olympia Othopaedic Associates
Olympia, Washington, 98502
The Rothman Institute
Philadelphia, Pennsylvania, 19107
Wm. Beaumont Hospital
Southfield, Michigan, 48034
Institute for Spine Care
Syracuse, New York, 13202
Madigan Army Medical Center
Tacoma, Washington, 98431-1100
Scott and White Memorial Hospital
Temple, Texas, 76508
Towson Orthopedic Associates
Towson, Maryland, 21204
Virginia Brain and Spine
Winchester, Virginia, 22601
About this study
Official title: A Prospective, Randomized, Multi-Center, Post-Approval Clinical Trial Evaluating the Long-Term (7 Year) Safety and Effectiveness of the PCM® Cervical Disc
On October 26, 2012, the FDA granted Premarket Approval (PMA) for the PCM Cervical Disc. PCM Cervical Disc is indicated for use in skeletally mature patients for reconstruction of a degenerated cervical disc at one level from C3-C4 to C6-C7 following single-level discectomy for intractable radiculopathy (arm pain and/or a neurological deficit), with or without neck pain, or myelopathy due to a single-level abnormality localized to the disc space, and manifested by at least one of the following conditions confirmed by radiographic imaging (CT, MRI, X-rays): herniated nucleus pulposus, spondylosis (defined by the presence of osteophytes), and/or visible loss of disc height as compared to adjacent levels.
The purpose of this post-approval study is to evaluate the long-term (7 year) safety and effectiveness of the PCM Cervical Disc.
Read the detailed description
A prospective, multi-center, post approval study with concurrent control group consisting of those patients that were enrolled and did not fail in the PCM Cervical Disc IDE clinical study and will to give consent to participate.
All of the PCM IDE investigational sites who have active patients will be chosen to participate in this study. All patients who are actively participating in the pivotal IDE study will be asked to participate in this study.
The study consists of follow-up periods only. The follow-up period will last for seven years from each patient's surgery date.
- Conditions
- Radiculopathy, Myelopathy
- Being tested
- PCM Cervical Disc, Anterior Cervical Discectomy and Fusion (ACDF)
- Medical subject headings
- Radiculopathy, Spinal Cord Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCM Cervical DiscDevice
Patients enrolled in the IDE clinical study and treated with the PCM Cervical Disc to treat degenerated cervical discs and neurological symptoms at one level from C3 to T1
Anterior Cervical Discectomy and Fusion (ACDF)Device
Patients enrolled in the IDE clinical study and treated with an anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
| Study group | Role | What they receive |
|---|---|---|
| PCM Cervical Disc | Experimental | Patients enrolled in the IDE clinical study and treated with the PCM Cervical Disc to treat degenerated cervical discs and neurological symptoms at one level from C3 to T1 Receives: Device: PCM Cervical Disc |
| Ant. Cervical Discectomy & Fusion(ACDF) | Active comparator | Patients enrolled in the IDE clinical study and treated with an anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1 Receives: Device: Anterior Cervical Discectomy and Fusion (ACDF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Individual Patient Overall Success
- Improvement of at least 20% on the Neck Disability Index (NDI) at 7 years compared to baseline
- No device failures requiring revision, reoperation, removal or supplemental fixation
- No major complications such as vascular or neurological injury
- Radiographic success
Measured: 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2013 (estimated)
- Study startApr 2013
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 494 participants (actual)
Sponsor and investigators
- Lead sponsor
- NuVasive
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01905930
- Sponsor's protocol ID
- NUVA-PCM-1101
- Status last verified
- May 2015
- First submitted
- 18 Jul 2013
- Last updated
- 21 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Multi-Center, Post-Approval Clinical Trial Evaluating the Long-Term (7 Year) Safety and Effectiveness of the PCM® Cervical Disc
- ClinicalTrials.gov ID
- NCT01905930
- Acronym / sponsor ID
- NUVA-PCM-1101
- Conditions
- Radiculopathy, Myelopathy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 494 participants (actual)
- Lead sponsor
- NuVasiveIndustry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 23 Jul 2013 (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.
On October 26, 2012, the FDA granted Premarket Approval (PMA) for the PCM Cervical Disc. PCM Cervical Disc is indicated for use in skeletally mature patients for reconstruction of a degenerated cervical disc at one level from C3-C4 to C6-C7 following single-level discectomy for intractable radiculopathy (arm pain and/or a neurological deficit), with or without neck pain, or myelopathy due to a single-level abnormality localized to the disc space, and manifested by at least one of the following conditions confirmed by radiographic imaging (CT, MRI, X-rays): herniated nucleus pulposus, spondylosis (defined by the presence of osteophytes), and/or visible loss of disc height as compared to adjacent levels.
The purpose of this post-approval study is to evaluate the long-term (7 year) safety and effectiveness of the PCM Cervical Disc.
Detailed description
A prospective, multi-center, post approval study with concurrent control group consisting of those patients that were enrolled and did not fail in the PCM Cervical Disc IDE clinical study and will to give consent to participate.
All of the PCM IDE investigational sites who have active patients will be chosen to participate in this study. All patients who are actively participating in the pivotal IDE study will be asked to participate in this study.
The study consists of follow-up periods only. The follow-up period will last for seven years from each patient's surgery date.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PCM Cervical Disc | Experimental | Device: PCM Cervical DiscPatients enrolled in the IDE clinical study and treated with the PCM Cervical Disc to treat degenerated cervical discs and neurological symptoms at one level from C3 to T1 |
| Ant. Cervical Discectomy & Fusion(ACDF) | Active comparator | Device: Anterior Cervical Discectomy and Fusion (ACDF)Patients enrolled in the IDE clinical study and treated with an anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients enrolled in the PCM Cervical Disc IDE clinical study
- Patients willing and able to give informed consent
Key exclusion criteria (2 listed)
- Patients considered failure during the PCM Cervical Disc IDE clinical study
- Patients who were withdrawn during the PCM Cervical Disc IDE clinical study
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 |
|---|---|---|
| PCM Cervical DiscPatients enrolled in the IDE clinical study and treated with the PCM Cervical Disc to treat degenerated cervical discs and neurological symptoms at one level from C3 to T1 | Device | PCM Cervical Disc |
| Anterior Cervical Discectomy and Fusion (ACDF)Patients enrolled in the IDE clinical study and treated with an anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1 | Device | Ant. Cervical Discectomy & Fusion(ACDF) |
Primary outcome
Individual Patient Overall Success
Time frame: 7 years
* Improvement of at least 20% on the Neck Disability Index (NDI) at 7 years compared to baseline * No device failures requiring revision, reoperation, removal or supplemental fixation * No major complications such as vascular or neurological injury * Radiographic success
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2015.
- Related InfoLink provided by the sponsor.
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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.
18 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 PCM Cervical Disc and Anterior Cervical Discectomy and Fusion (ACDF) in people with Radiculopathy and Myelopathy, run by NuVasive at 18 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 2 inclusion and 2 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 21 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Individual Patient Overall Success (time frame: 7 years). 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 21 May 2015.