Cervical Disc DiseaseNCT03367052
Clinical and Radiological Outcomes: Two-level Cervical ProDisc-C Vivo Versus Hybrid Construct.
A study testing Two level Prodisc-C vivo and Hybrid in people with Cervical Disc Disease, run by Peking University People's Hospital.
Trial summary
The objective of this study is to investigate the clinical and radiological results of two-level cervical ProDisc-C vivo versus hybrid construct. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Cervical Disc Disease
- What is being tested?
- Two level Prodisc-C vivo and Hybrid
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 542 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2018to 1 Dec 2025
- Phase
- Interventional
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A diagnosis of degenerative disc disease with radiculopathy or myeloradiculopathy at 2 contiguous levels from C-3 to C-7.
- The symptom is unresponsive to nonoperative treatment for at least 6 weeks.
- The patient demonstrates progressive symptoms calling for immediate surgery.
Who cannot join
- Any prior cervical spine surgery.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Clinical and Radiological Outcomes of a 7-year Follow-up, Multi-center, Prospective, Randomized, Controlled Trial: Two-level Cervical ProDisc-C Vivo Versus Hybrid Construct.
The objective of this study is to investigate the clinical and radiological results of two-level cervical ProDisc-C vivo versus hybrid construct.
Read the detailed description
This is a prospective, randomized, multicenter trial at 7 years of follow-up comparing two level ProDisc-C vivo artificial cervical disc replacement and hybrid construct, i.e., combining ACDF (Anterior cervical discectomy fusion) and ProDisc-C vivo to treat degenerative disc disease (DDD). 542 DDD patients (age from 20 to 70) from several hospitals matching the inclusion criteria will be randomly assigned to two groups (271 patients in each group). One group will be treated with two level ProDisc-C vivo disc replacement. The other group will be treated with hybrid construct. Clinical outcomes and radiological analysis will be done at 1.5, 3, 6, 12, 24, 36, 60, and 84 months after the surgical treatments.
- Conditions
- Cervical Disc Disease
- Being tested
- Two level Prodisc-C vivo, Hybrid
- Keywords
- ProDisc-C vivo, Hybrid, Cervical degenerative disc disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Two level Prodisc-C vivoProcedure or surgery
Two level of Prodisc-C vivo artificial disc replacement will be done in one group of patients.
HybridProcedure or surgery
The hybrid method will be used in one group of patients.
| Study group | Role | What they receive |
|---|---|---|
| Two level Prodisc-C vivo | Experimental | Two level Prodisc-C vivo cervical artificial disc replacement. Receives: Procedure: Two level Prodisc-C vivo |
| Hybrid | Active comparator | This group of patients will be treated with hybrid construct, i.e., one level of Prodisc-C vivo and one level of anterior cervical discectomy fusion (ACDF). Receives: Procedure: Hybrid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of overall success rate
A patient's outcome was considered an overall success if all of the following conditions were met:1) postoperative (Neck Disability Index) NDI score improvement of at least a 15-point increase from preoperative score; 2) maintenance or improvement in neurological status; 3) disc height success; 4) no serious adverse event classified as implant associated or implant/surgical procedure associated; and 5) no additional surgical procedure classified as a "failure".
Measured: The overall success will be assessed at each time point (1.5, 3, 6, 12, 24, 36, 60, and 84 months after the surgical treatments).
Secondary outcomes (3)
Change of sagittal angular motion
Neutral anteroposterior and lateral radiographs and dynamic flexion-extension lateral radiographs.
Measured: The radiographs will be obtained at each study point (before surgery,1.5, 3, 6, 12, 24, 36, 60, and 84 months after the surgical treatments).
Change of NDI Scores
The neck disability index(NDI) questionnaire measures the level of pain and disability associated with various activities. The NDI is a 10-item, 50-point index that assesses different aspects of daily functioning in patients with neck pain. Each item is scored 0 to 5. The NDI score is a sum of the scores of the10-item. Clinical effects will be evaluated based on scores of the NDI. Higher values represent a better outcome.
Measured: The NDI scores will be assessed at each study point (before surgery,1.5, 3, 6, 12, 24, 36, 60, and 84 months after the surgical treatments).
Change of Arm and Neck pain
Neck and arm pain scores will be measured using a visual analogue scale (VAS) from "0' (no sensation) to '100"(the most intense pain imaginable) where 30 means "pain threshold".
Measured: Neck and arm pain scores will be measured at each study point (before surgery,1.5, 3, 6, 12, 24, 36, 60, and 84 months after the surgical treatments).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2017
- Study start1 Jan 2018 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cervical Disc DiseaseStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe 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
- Model description
- 542 DDD patients (age from 20 to 70) from several hospitals matching the inclusion criteria will be randomly assigned to two groups (271 patients in each group). One group will be treated with two level ProDisc-C vivo disc replacement. The other group will be treated with hybrid construct. Clinical outcomes and radiological analysis will be compared between the two groups at 1.5, 3, 6, 12, 24, 36, 60, and 84 months after the surgical treatments.
- Masking
- None (open label)
- Enrolment
- 542 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, guochen, Peking University People's Hospital
- Investigators
- chen guo, Master, Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03367052
- Sponsor's protocol ID
- twolevelprodiscC
- Status last verified
- Dec 2017
- First submitted
- 29 Nov 2017
- Last updated
- 8 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zigler JE, Delamarter R, Murrey D, Spivak J, Janssen M. ProDisc-C and anterior cervical discectomy and fusion as surgical treatment for single-level cervical symptomatic degenerative disc disease: five-year results of a Food and Drug Administration study. Spine (Phila Pa 1976). 2013 Feb 1;38(3):203-9. doi: 10.1097/BRS.0b013e318278eb38.
PubMed 23080427Davis RJ, Kim KD, Hisey MS, Hoffman GA, Bae HW, Gaede SE, Rashbaum RF, Nunley PD, Peterson DL, Stokes JK. Cervical total disc replacement with the Mobi-C cervical artificial disc compared with anterior discectomy and fusion for treatment of 2-level symptomatic degenerative disc disease: a prospective, randomized, controlled multicenter clinical trial: clinical article. J Neurosurg Spine. 2013 Nov;19(5):532-45. doi: 10.3171/2013.6.SPINE12527. Epub 2013 Sep 6.
PubMed 24010901
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiological Outcomes of a 7-year Follow-up, Multi-center, Prospective, Randomized, Controlled Trial: Two-level Cervical ProDisc-C Vivo Versus Hybrid Construct.
- ClinicalTrials.gov ID
- NCT03367052
- Acronym / sponsor ID
- twolevelprodiscC
- Conditions
- Cervical Disc Disease
- Keywords
- ProDisc-C vivo, Hybrid, Cervical degenerative disc disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 542 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 1 Jan 2018 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 8 Dec 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 objective of this study is to investigate the clinical and radiological results of two-level cervical ProDisc-C vivo versus hybrid construct.
Detailed description
This is a prospective, randomized, multicenter trial at 7 years of follow-up comparing two level ProDisc-C vivo artificial cervical disc replacement and hybrid construct, i.e., combining ACDF (Anterior cervical discectomy fusion) and ProDisc-C vivo to treat degenerative disc disease (DDD). 542 DDD patients (age from 20 to 70) from several hospitals matching the inclusion criteria will be randomly assigned to two groups (271 patients in each group). One group will be treated with two level ProDisc-C vivo disc replacement. The other group will be treated with hybrid construct. Clinical outcomes and radiological analysis will be done at 1.5, 3, 6, 12, 24, 36, 60, and 84 months after the surgical treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 542 DDD patients (age from 20 to 70) from several hospitals matching the inclusion criteria will be randomly assigned to two groups (271 patients in each group). One group will be treated with two level ProDisc-C vivo disc replacement. The other group will be treated with hybrid construct. Clinical outcomes and radiological analysis will be compared between the two groups at 1.5, 3, 6, 12, 24, 36, 60, and 84 months after the surgical treatments.
| Arm | Type | Receives |
|---|---|---|
| Two level Prodisc-C vivo | Experimental | Procedure: Two level Prodisc-C vivoTwo level Prodisc-C vivo cervical artificial disc replacement. |
| Hybrid | Active comparator | Procedure: HybridThis group of patients will be treated with hybrid construct, i.e., one level of Prodisc-C vivo and one level of anterior cervical discectomy fusion (ACDF). |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- A diagnosis of degenerative disc disease with radiculopathy or myeloradiculopathy at 2 contiguous levels from C-3 to C-7.
- The symptom is unresponsive to nonoperative treatment for at least 6 weeks.
- The patient demonstrates progressive symptoms calling for immediate surgery.
Key exclusion criteria (1 listed)
- Any prior cervical spine surgery.
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 |
|---|---|---|
| Two level Prodisc-C vivoTwo level of Prodisc-C vivo artificial disc replacement will be done in one group of patients. | Procedure or surgery | Two level Prodisc-C vivo |
| HybridThe hybrid method will be used in one group of patients. | Procedure or surgery | Hybrid |
Primary outcome
Change of overall success rate
Time frame: The overall success will be assessed at each time point (1.5, 3, 6, 12, 24, 36, 60, and 84 months after the surgical treatments).
A patient's outcome was considered an overall success if all of the following conditions were met:1) postoperative (Neck Disability Index) NDI score improvement of at least a 15-point increase from preoperative score; 2) maintenance or improvement in neurological status; 3) disc height success; 4) no serious adverse event classified as implant associated or implant/surgical procedure associated; and 5) no additional surgical procedure classified as a "failure".
3 secondary outcomes
Change of sagittal angular motion
Time frame: The radiographs will be obtained at each study point (before surgery,1.5, 3, 6, 12, 24, 36, 60, and 84 months after the surgical treatments).
Change of NDI Scores
Time frame: The NDI scores will be assessed at each study point (before surgery,1.5, 3, 6, 12, 24, 36, 60, and 84 months after the surgical treatments).
Change of Arm and Neck pain
Time frame: Neck and arm pain scores will be measured at each study point (before surgery,1.5, 3, 6, 12, 24, 36, 60, and 84 months after the surgical treatments).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2017.
- Background: PubMed 23080427Zigler JE, Delamarter R, Murrey D, Spivak J, Janssen M. ProDisc-C and anterior cervical discectomy and fusion as surgical treatment for single-level cervical symptomatic degenerative disc disease: five-year results of a Food and Drug Administration study. Spine (Phila Pa 1976). 2013 Feb 1;38(3):203-9. doi: 10.1097/BRS.0b013e318278eb38.
- Background: PubMed 24010901Davis RJ, Kim KD, Hisey MS, Hoffman GA, Bae HW, Gaede SE, Rashbaum RF, Nunley PD, Peterson DL, Stokes JK. Cervical total disc replacement with the Mobi-C cervical artificial disc compared with anterior discectomy and fusion for treatment of 2-level symptomatic degenerative disc disease: a prospective, randomized, controlled multicenter clinical trial: clinical article. J Neurosurg Spine. 2013 Nov;19(5):532-45. doi: 10.3171/2013.6.SPINE12527. Epub 2013 Sep 6.
- 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.
chen guo, Master principal investigator
Peking University People's Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Two level Prodisc-C vivo and Hybrid in people with Cervical Disc Disease, run by Peking University People's Hospital.
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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 8 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Weiwei Xia, Ph.D. (008613260001978, 523526767@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of overall success rate (time frame: The overall success will be assessed at each time point (1.5, 3, 6, 12, 24, 36, 60, and 84 months after the surgical treatments).). 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 NCT03367052, which also lists 2 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 8 Dec 2017.