Condition or disease | Intervention/treatment | Phase |
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Symptomatic Cervical Disc Disease | Device: prodisc C SK and/or Vivo Device: Mobi-C Cervical Disc | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 390 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | multi-center, prospective, randomized, controlled comparison |
Masking: | Single (Participant) |
Masking Description: | Patient is blinded to their treatment randomization until after surgery. |
Primary Purpose: | Treatment |
Official Title: | A Multi-Center, Prospective, Randomized Controlled Trial Comparing the Safety and Effectiveness of Prodisc® C SK and Prodisc® C Vivo to Mobi-C® Cervical Disc in the Treatment of Two-Level Symptomatic Cervical Disc Disease (SCDD) |
Actual Study Start Date : | August 5, 2019 |
Estimated Primary Completion Date : | January 2023 |
Estimated Study Completion Date : | February 2028 |
Arm | Intervention/treatment |
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Experimental: Investigational
Two-level prodisc C SK and/or prodisc C Vivo
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Device: prodisc C SK and/or Vivo
Subjects will be randomized in a 2:1 ratio either to the two-level prodisc C SK or prodisc C Vivo device (investigational group) or to the two-level Mobi-C device (control group).
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Active Comparator: Control
Two-level Mobi-C device
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Device: Mobi-C Cervical Disc
Subjects will be randomized in a 2:1 ratio either to the two-level prodisc C SK or prodisc C Vivo device (investigational group) or to the two-level Mobi-C device (control group).
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Ages Eligible for Study: | 18 Years to 69 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Diagnosis of radiculopathy or myelopathy with radiculopathy of the cervical spine, with pain, paresthesias or paralysis in a specific nerve root distribution C3 through C7, including at least one of the following:
Radiographically determined pathology at the level to be treated correlating to primary symptoms including at least one of the following:
Unresponsive to non-operative, conservative treatment (rest, heat, electrotherapy, physical therapy, chiropractic care and/or analgesics) for:
Exclusion Criteria:
Have marked cervical instability on resting (neutral) lateral or flexion-extension radiographs demonstrated by:
Contact: Angela Waltman | 484-887-8867 | a.waltman@centinelspine.com | |
Contact: Angela Waltman, MD, PhD | 484-887-8867 | a.waltman@centinelspine.com |
Study Director: | Leonard I Voronov, MD, PhD | Centinel Spine |
Tracking Information | |||||||||
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First Submitted Date ICMJE | July 5, 2019 | ||||||||
First Posted Date ICMJE | July 9, 2019 | ||||||||
Last Update Posted Date | April 29, 2021 | ||||||||
Actual Study Start Date ICMJE | August 5, 2019 | ||||||||
Estimated Primary Completion Date | January 2023 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
Composite clinical success rate of the two-level prodisc C SK and prodisc C Vivo will be no worse than marketed cervical disc prosthesis (Mobi-C) [ Time Frame: 24 months ] Includes assessments such as NDI and neurological improvement.
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | 2-level Cervical Disc Replacement Comparing Prodisc C SK & Vivo to Mobi-C | ||||||||
Official Title ICMJE | A Multi-Center, Prospective, Randomized Controlled Trial Comparing the Safety and Effectiveness of Prodisc® C SK and Prodisc® C Vivo to Mobi-C® Cervical Disc in the Treatment of Two-Level Symptomatic Cervical Disc Disease (SCDD) | ||||||||
Brief Summary | A multi-center, prospective, randomized, controlled comparison of the prodisc C SK and prodisc C Vivo to the control, a similar, legally marketed total disc replacement device in subjects with symptomatic cervical disc disease (SCDD). | ||||||||
Detailed Description | The clinical trial is to demonstrate that prodisc C SK and prodisc C Vivo are at least as safe and effective as a similar, currently marketed cervical disc prosthesis to treat symptomatic cervical disc disease (SCDD) in subjects at two contiguous levels from C3 to C7 who are unresponsive to conservative management. Subjects will be randomized in a 2:1 ratio to either the two-level prodisc C SK or prodisc C Vivo device (investigational group) or to the two-level Mobi-C device (control group). Subjects will be followed for at least 2 years and up to 5 years. Subjects will be required to complete subject questionnaires, have X-rays and undergo neurological assessments during the follow up visits as specified in the protocol. | ||||||||
Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Not Applicable | ||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: multi-center, prospective, randomized, controlled comparison Masking: Single (Participant)Masking Description: Patient is blinded to their treatment randomization until after surgery. Primary Purpose: Treatment
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Condition ICMJE | Symptomatic Cervical Disc Disease | ||||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
390 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | February 2028 | ||||||||
Estimated Primary Completion Date | January 2023 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 69 Years (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | Yes | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT04012996 | ||||||||
Other Study ID Numbers ICMJE | VAL-P-0022 | ||||||||
Has Data Monitoring Committee | No | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Centinel Spine | ||||||||
Study Sponsor ICMJE | Centinel Spine | ||||||||
Collaborators ICMJE | Not Provided | ||||||||
Investigators ICMJE |
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PRS Account | Centinel Spine | ||||||||
Verification Date | April 2021 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |