Cervical Disc DiseaseNCT03077516
Post-Market, Long-Term Follow Up of Mobi-C® Cervical Disc for One and Two Level Treatment of Cervical Disc Disease
An observational study of Cervical Disc Disease and Cervical Disc Degeneration, run by LDR Spine USA at 8 sites in United States.
Trial summary
The purpose of this study is to evaluate clinical and patient-reported outcomes at 10 years following surgery for a cohort of Mobi-C subjects treated on the IDE/Post Approval studies Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cervical Disc Disease, Cervical Disc Degeneration
- What is being tested?
- Mobi-C
- Type of treatment
- Medical device
- How many people
- 216 participants
- Where
- 8 sitesUnited States
- Study dates
- Nov 2016to 31 Oct 2019
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Mobi-C and control subjects treated on the IDE/Post Approval studies, with one or two level disc replacement
Who may be able to join
- Prior enrollment in LDR-001 Pivotal Study (IDE G050212);
- Written informed consent provided by subject or subject's legally authorized representative
Who cannot join
- Documented withdrawal of consent from prior Mobi-C study;
- Documented non-compliance (including unwillingness to return to the site for follow-up visits)
- Reported pregnancy at time of enrollment, or with plans to become pregnant prior to completing study X-Rays
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Orthopedics Northeast
Fort Wayne, Indiana, 46825
Orange County Neurosurgical Associates
Laguna Hills, California, 92653
Texas Back Institute
Plano, Texas, 75093
Desert Orthopedic Center
Rancho Mirage, California, 92270
UC Davis Spine Center
Sacramento, California, 95816
The Spine Institute
Santa Monica, California, 90403
Spine Institute of Louisiana
Shreveport, Louisiana, 71101
Texas Spine and Joint Hospital
Tyler, Texas, 75701
About this study
The purpose of this study is to evaluate clinical and patient-reported outcomes at 10 years following surgery for a cohort of Mobi-C subjects treated on the IDE/Post Approval studies
Read the detailed description
This is a prospective, multi-center, consecutive cohort study. Subjects invited to participate in this study will have completed the Mobi-C IDE study (G050212). In this study, five hundred and seventy-five subjects were randomized to either the Mobi-C prosthesis or the control treatment - conventional anterior cervical discectomy and fusion (ACDF) with anterior cervical plating. The study was randomized in a 2 to 1 ratio (two Mobi-C subjects for every one subject receiving ACDF with anterior cervical plate). The subject retention rate for Mobi-C subjects was 80.1% (1 level)-84.4% (2 level) at 7 years.
As non-inferiority (1-level) and superiority (2-level) have been well established through 7 years, the design of this study will focus on the long-term outcomes of a cohort of the Mobi-C arm of the study and evaluate the durability of outcomes at 10 years. Study sites invited to participate will be those that enrolled at least 10 subjects, and also had the highest retention rates at 7 years (≥70%). All subjects at these sites will be contacted to participate in an additional 10 year follow up visit. It is estimated that up to 250 subjects will be enrolled at 9-12 study sites.
Certain endpoints are better assessed in comparison to the control ACDF arm, such as adjacent segment degeneration and subsequent surgery. This study has been amended to include a subset of sites that will also enroll control subjects. Up to 3 sites and 50 subjects will be included in this control cohort.
- Conditions
- Cervical Disc Disease, Cervical Disc Degeneration
- Being tested
- Mobi-C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobi-CDevice
Also called Mobi-C Cervical Disc Prosthesis
Device for cervical intervertebral disc replacement at one or two contiguous levels
| Study group | Role | What they receive |
|---|---|---|
| Mobi-C | Prior recipient of Mobi-C Disc in IDE/Post Approval Study Receives: Device: Mobi-C | |
| ACDF | Prior control subject in IDE/Post Approval Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
NDI Score
Measured: 10 Years
Secondary outcomes (11)
Overall Success
Composite score composed of: 1) NDI improvement of at least 15 points (out of 50) from baseline; 2) No subsequent surgical intervention at the index level or levels; 3) No potentially (possibly or probably) device-related adverse event; 4) Maintenance or improvement in all components of neurologic status; and 5) No Mobi-C intraoperative changes in treatment.
Measured: 10 Year
Neck Pain/Arm Pain VAS
Measured: 10 Year
QOL SF-12
Measured: 10 Year
Patient Satisfaction
Measured by a two questions scale that includes ranking of level of satisfaction and willingness to recommend treatment.
Measured: 10 Year
Secondary surgery Rate
Measured: 10 Years
Device related complications
Measured: 10 Years
Device displacement or migration
Radiographic assessment of movement of device from original placement
Measured: 10 Year
Range of motion
Radiographically measured angle, in degrees, between endplates of adjacent vertebrae
Measured: 10 Years
Disc Height
Radiographically measured distance, in mm, from corner of superior vertebra to corresponding corner of inferior vertebra
Measured: 10 Years
Heterotopic Ossification
Qualitative radiographic assessment using McAfee grading system, grades 1-4
Measured: 10 Years
Adjacent Segment Degeneration
Qualitative radiographic assessment using Kellgren-Lawrence Disc Degeneration Grading, grades 0-IV
Measured: 10 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2017
- Study startNov 2016
- Primary completion31 Oct 2019
- Study completion31 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cervical 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
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- LDR Spine USA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03077516
- Sponsor's protocol ID
- MC-100
- Status last verified
- Dec 2019
- First submitted
- 28 Nov 2016
- Last updated
- 4 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Radcliff K, Coric D, Albert T. Five-year clinical results of cervical total disc replacement compared with anterior discectomy and fusion for treatment of 2-level symptomatic degenerative disc disease: a prospective, randomized, controlled, multicenter investigational device exemption clinical trial. J Neurosurg Spine. 2016 Aug;25(2):213-24. doi: 10.3171/2015.12.SPINE15824. Epub 2016 Mar 25.
PubMed 27015130Hisey MS, Zigler JE, Jackson R, Nunley PD, Bae HW, Kim KD, Ohnmeiss DD. Prospective, Randomized Comparison of One-level Mobi-C Cervical Total Disc Replacement vs. Anterior Cervical Discectomy and Fusion: Results at 5-year Follow-up. Int J Spine Surg. 2016 Feb 26;10:10. doi: 10.14444/3010. eCollection 2016.
PubMed 27162712Jackson RJ, Davis RJ, Hoffman GA, Bae HW, Hisey MS, Kim KD, Gaede SE, Nunley PD. Subsequent surgery rates after cervical total disc replacement using a Mobi-C Cervical Disc Prosthesis versus anterior cervical discectomy and fusion: a prospective randomized clinical trial with 5-year follow-up. J Neurosurg Spine. 2016 May;24(5):734-45. doi: 10.3171/2015.8.SPINE15219. Epub 2016 Jan 22.
PubMed 26799118Ament JD, Yang Z, Nunley P, Stone MB, Lee D, Kim KD. Cost Utility Analysis of the Cervical Artificial Disc vs Fusion for the Treatment of 2-Level Symptomatic Degenerative Disc Disease: 5-Year Follow-up. Neurosurgery. 2016 Jul;79(1):135-45. doi: 10.1227/NEU.0000000000001208.
PubMed 26855020
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Market, Long-Term Follow Up of Mobi-C® Cervical Disc for One and Two Level Treatment of Cervical Disc Disease
- ClinicalTrials.gov ID
- NCT03077516
- Acronym / sponsor ID
- MC-100
- Conditions
- Cervical Disc Disease, Cervical Disc Degeneration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- LDR Spine USAIndustry (pharma, biotech, devices)
- Study start
- Nov 2016 (actual)
- Primary completion
- 31 Oct 2019 (actual)
- Study completion
- 31 Oct 2019 (actual)
- First posted
- 13 Mar 2017 (actual)
- 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.
The purpose of this study is to evaluate clinical and patient-reported outcomes at 10 years following surgery for a cohort of Mobi-C subjects treated on the IDE/Post Approval studies
Detailed description
This is a prospective, multi-center, consecutive cohort study. Subjects invited to participate in this study will have completed the Mobi-C IDE study (G050212). In this study, five hundred and seventy-five subjects were randomized to either the Mobi-C prosthesis or the control treatment - conventional anterior cervical discectomy and fusion (ACDF) with anterior cervical plating. The study was randomized in a 2 to 1 ratio (two Mobi-C subjects for every one subject receiving ACDF with anterior cervical plate). The subject retention rate for Mobi-C subjects was 80.1% (1 level)-84.4% (2 level) at 7 years.
As non-inferiority (1-level) and superiority (2-level) have been well established through 7 years, the design of this study will focus on the long-term outcomes of a cohort of the Mobi-C arm of the study and evaluate the durability of outcomes at 10 years. Study sites invited to participate will be those that enrolled at least 10 subjects, and also had the highest retention rates at 7 years (≥70%). All subjects at these sites will be contacted to participate in an additional 10 year follow up visit. It is estimated that up to 250 subjects will be enrolled at 9-12 study sites.
Certain endpoints are better assessed in comparison to the control ACDF arm, such as adjacent segment degeneration and subsequent surgery. This study has been amended to include a subset of sites that will also enroll control subjects. Up to 3 sites and 50 subjects will be included in this control cohort.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mobi-C | – | Device: Mobi-CPrior recipient of Mobi-C Disc in IDE/Post Approval Study |
| ACDF | – | –Prior control subject in IDE/Post Approval Study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Mobi-C and control subjects treated on the IDE/Post Approval studies, with one or two level disc replacement
Key inclusion criteria (2 listed)
- Prior enrollment in LDR-001 Pivotal Study (IDE G050212);
- Written informed consent provided by subject or subject's legally authorized representative
Key exclusion criteria (3 listed)
- Documented withdrawal of consent from prior Mobi-C study;
- Documented non-compliance (including unwillingness to return to the site for follow-up visits)
- Reported pregnancy at time of enrollment, or with plans to become pregnant prior to completing study X-Rays
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 |
|---|---|---|
| Mobi-CAlso: Mobi-C Cervical Disc ProsthesisDevice for cervical intervertebral disc replacement at one or two contiguous levels | Device | Mobi-C |
Primary outcome
NDI Score
Time frame: 10 Years
11 secondary outcomes
Overall Success
Time frame: 10 Year
Neck Pain/Arm Pain VAS
Time frame: 10 Year
QOL SF-12
Time frame: 10 Year
Patient Satisfaction
Time frame: 10 Year
Secondary surgery Rate
Time frame: 10 Years
Device related complications
Time frame: 10 Years
Device displacement or migration
Time frame: 10 Year
Range of motion
Time frame: 10 Years
Disc Height
Time frame: 10 Years
Heterotopic Ossification
Time frame: 10 Years
Adjacent Segment Degeneration
Time frame: 10 Years
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 4 Dec 2019.
- Background: PubMed 27015130Radcliff K, Coric D, Albert T. Five-year clinical results of cervical total disc replacement compared with anterior discectomy and fusion for treatment of 2-level symptomatic degenerative disc disease: a prospective, randomized, controlled, multicenter investigational device exemption clinical trial. J Neurosurg Spine. 2016 Aug;25(2):213-24. doi: 10.3171/2015.12.SPINE15824. Epub 2016 Mar 25.
- Background: PubMed 27162712Hisey MS, Zigler JE, Jackson R, Nunley PD, Bae HW, Kim KD, Ohnmeiss DD. Prospective, Randomized Comparison of One-level Mobi-C Cervical Total Disc Replacement vs. Anterior Cervical Discectomy and Fusion: Results at 5-year Follow-up. Int J Spine Surg. 2016 Feb 26;10:10. doi: 10.14444/3010. eCollection 2016.
- Background: PubMed 26799118Jackson RJ, Davis RJ, Hoffman GA, Bae HW, Hisey MS, Kim KD, Gaede SE, Nunley PD. Subsequent surgery rates after cervical total disc replacement using a Mobi-C Cervical Disc Prosthesis versus anterior cervical discectomy and fusion: a prospective randomized clinical trial with 5-year follow-up. J Neurosurg Spine. 2016 May;24(5):734-45. doi: 10.3171/2015.8.SPINE15219. Epub 2016 Jan 22.
- Background: PubMed 26855020Ament JD, Yang Z, Nunley P, Stone MB, Lee D, Kim KD. Cost Utility Analysis of the Cervical Artificial Disc vs Fusion for the Treatment of 2-Level Symptomatic Degenerative Disc Disease: 5-Year Follow-up. Neurosurgery. 2016 Jul;79(1):135-45. doi: 10.1227/NEU.0000000000001208.
- Individual participant dataSharing planned: No
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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.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Disc Disease and Cervical Disc Degeneration, run by LDR Spine USA at 8 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 3 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 4 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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 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?
NDI Score (time frame: 10 Years). 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 NCT03077516, which also lists 4 linked publications.
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 Dec 2019.