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出境医 / 临床实验 / PMCF Neo Pedicle Screw and Cage Systems
PMCF Neo Pedicle Screw and Cage Systems
Study Description
Brief Summary:
The objectives of this clinical observational study is to evaluate the safety and efficacy (performance) of the Neo Pedicle Screw System™ and the Neo Cage System™ interbody fusion device. To demonstrate non-inferiority of safety and function to an historical control from the published medical literature on competitive devices.
| Condition or disease | Intervention/treatment |
|---|---|
| Degenerative Disc Disease Spondylolisthesis Spinal Stenosis Spinal Tumor Trauma Pseudoarthrosis of Spine | Device: NEO Pedicle Screw System™ Device: Neo Cage System™ |
Study Design
| Study Type : | Observational |
| Estimated Enrollment : | 150 participants |
| Observational Model: | Cohort |
| Time Perspective: | Other |
| Official Title: | Fusion With the Neo Pedicle Screw and Cage Systems: A Post Market Clinical Follow-up Study |
| Actual Study Start Date : | October 15, 2019 |
| Estimated Primary Completion Date : | July 2023 |
| Estimated Study Completion Date : | July 2023 |
Arms and Interventions
| Group/Cohort | Intervention/treatment |
|---|---|
| Pedicle screw system alone |
Device: NEO Pedicle Screw System™
The NEO Pedicle Screw System™ is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion.
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| Pedicle screw system with cages |
Device: NEO Pedicle Screw System™
The NEO Pedicle Screw System™ is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion.
Device: Neo Cage System™ Neo Cage System™ is intended to be used with bone graft material to facilitate interbody fusion and to be used with the NEO Pedicle Screw System™
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Outcome Measures
Primary Outcome Measures :
- Change in patient´s function from baseline to 12 months [ Time Frame: 12 months ]Clinical outcome in function as measured by the 100 point Oswestry Disability Index (ODI). Zero is equated with no disability and 100 is the maximum disability possible.
- The rate of cage migration in cage-plus-screw systems. [ Time Frame: 12 months and 24 months post operatively ]Defined as posterior movement of the cage past the posterior wall of the vertebral body.
- The rate of pedicle screw loosening in screw only and cage-plus-screw systems. [ Time Frame: 12 months and 24 months post operatively ]A radiolucent zone, >1mm, surrounding the pedicle screw seen in radiograhs
Eligibility Criteria
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
In total, approximately 150 patients will be recruited and enrolled to ensure that at least 132 patients are evaluable at 12 and 24 months. Patients are recruited consecutively, retrospectively as well as prospectively. The potential patients to be recruited have either already been implanted or are planned to be implanted with the Neo Pedicle Screw System (Arm 1) or Neo Cage System and Neo Pedicle Screw System (Arm 2).
Criteria
Inclusion criteria:
- Patient has undergone or is intended to undergo surgery with the Neo Pedicle Screw System™, standalone or in combination with the Neo Cage System™, for any of the approved indications as defined in the respective labelling
- Patient has participated in or is willing to participate in the routine postoperative follow-up program
- Patient is willing to provide written informed consent
Exclusion criteria:
- Patient is under the age of 18 or skeletally immature
- Patient had or has a contraindication to surgery or to any of the implant systems used in the study, as defined in the respective labelling
Contacts and Locations
Contacts
| Contact: ingrid Moberg, DDS | +46 725 45 35 29 | ingrid.moberg@neo-medical.com |
Locations
| Germany | |
| Dep. of Neurosurgery, Nordwest Krankenhaus Sanderbusch | Recruiting |
| Sande, Germany, 26452 | |
| Contact: Yasser Abdalla, MD +49 162 2018181 y.abdalla@sanderbusch.de | |
| Spain | |
| Spine Center, University Hospital Valladolid | Recruiting |
| Valladolid, Spain, 47006 | |
| Contact: David C Noriega, PhD, MD +34 630 381 468 noriega1970@icloud.com | |
Sponsors and Collaborators
Neo Medical SA
ConfinisCPM
Investigators
| Principal Investigator: | David C Noriega, PhD, MD | Spine Center, University Hospital Valladolid, Valladolid, Spain | |
| Principal Investigator: | Yasser Abdalla, MD | Dep. of Neurosurgery, Nordwest Krankenhaus Sanderbusch, Sande, Germany |
| Tracking Information | |||||||
|---|---|---|---|---|---|---|---|
| First Submitted Date | May 16, 2019 | ||||||
| First Posted Date | May 20, 2019 | ||||||
| Last Update Posted Date | March 3, 2021 | ||||||
| Actual Study Start Date | October 15, 2019 | ||||||
| Estimated Primary Completion Date | July 2023 (Final data collection date for primary outcome measure) | ||||||
| Current Primary Outcome Measures |
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| Original Primary Outcome Measures |
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| Change History | |||||||
| Current Secondary Outcome Measures | Not Provided | ||||||
| Original Secondary Outcome Measures | Not Provided | ||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||
| Descriptive Information | |||||||
| Brief Title | PMCF Neo Pedicle Screw and Cage Systems | ||||||
| Official Title | Fusion With the Neo Pedicle Screw and Cage Systems: A Post Market Clinical Follow-up Study | ||||||
| Brief Summary | The objectives of this clinical observational study is to evaluate the safety and efficacy (performance) of the Neo Pedicle Screw System™ and the Neo Cage System™ interbody fusion device. To demonstrate non-inferiority of safety and function to an historical control from the published medical literature on competitive devices. | ||||||
| Detailed Description | Not Provided | ||||||
| Study Type | Observational | ||||||
| Study Design | Observational Model: Cohort Time Perspective: Other |
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| Target Follow-Up Duration | Not Provided | ||||||
| Biospecimen | Not Provided | ||||||
| Sampling Method | Non-Probability Sample | ||||||
| Study Population | In total, approximately 150 patients will be recruited and enrolled to ensure that at least 132 patients are evaluable at 12 and 24 months. Patients are recruited consecutively, retrospectively as well as prospectively. The potential patients to be recruited have either already been implanted or are planned to be implanted with the Neo Pedicle Screw System (Arm 1) or Neo Cage System and Neo Pedicle Screw System (Arm 2). | ||||||
| Condition |
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| Intervention |
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| Study Groups/Cohorts |
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| Publications * | Not Provided | ||||||
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* 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 | Recruiting | ||||||
| Estimated Enrollment |
150 | ||||||
| Original Estimated Enrollment | Same as current | ||||||
| Estimated Study Completion Date | July 2023 | ||||||
| Estimated Primary Completion Date | July 2023 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria |
Inclusion criteria:
Exclusion criteria:
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||||||
| Accepts Healthy Volunteers | No | ||||||
| Contacts |
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| Listed Location Countries | Germany, Spain | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number | NCT03956537 | ||||||
| Other Study ID Numbers | NeoPMCF01 | ||||||
| Has Data Monitoring Committee | Not Provided | ||||||
| U.S. FDA-regulated Product | Not Provided | ||||||
| IPD Sharing Statement | Not Provided | ||||||
| Responsible Party | Neo Medical SA | ||||||
| Study Sponsor | Neo Medical SA | ||||||
| Collaborators | ConfinisCPM | ||||||
| Investigators |
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| PRS Account | Neo Medical SA | ||||||
| Verification Date | March 2021 | ||||||
