Status:
TERMINATED
Fenestrated Screw Study
Lead Sponsor:
Medtronic Spinal and Biologics
Conditions:
Degenerative Spinal Disease
Deformity of Spine
Eligibility:
All Genders
22+ years
Phase:
NA
Brief Summary
The primary objective of this post-market study is to demonstrate that Oswestry disability index (ODI) score improved significantly at 12 months post-operatively as compared to baseline for each indic...
Eligibility Criteria
Inclusion
- A subject must meet the following inclusion criteria to participate in this trial:
- One or more of the following diagnostic indications:
- Degenerative Spinal Disease (e.g. degenerative disc disease, spondylolisthesis and/or spinal stenosis)
- Deformity (e.g. degenerative deformity)
- Degenerative Spinal Disease patients only: Patient has been unresponsive to non-operative treatment for at least three months or has progressive symptoms or signs of nerve root/spinal cord compression while undergoing continued non-operative management.
- Compromised bone quality defined as a hip DXA scan T-score less than or equal to -1.0 or spine quantitative CT (qCT) actual volumetric bone mineral density threshold of ≤ 120 mg/cm3.
- Requires a procedure with an instrumented, posterior thoracic and/or lumbar spinal stabilization and/or immobilization.
- Is scheduled to receive a construct using CD Horizon® Spinal System components with at least one Fenestrated Screw cemented with Fenestrated Screw Cement.
- At least 22 years old or greater at the time of informed consent.
- Is able to understand and willing to sign the Patient Informed Consent Form.
- Is willing and able to undergo the study procedure and perform the follow up visits.
Exclusion
- A subject will be excluded from participating in this trial for any of the following reasons:
- Has undergone stabilization and/or fusion procedure at the index or adjacent levels.
- Will undergo vertebroplasty or kyphoplasty procedure during surgery.
- Has been diagnosed with cauda equina syndrome.
- Has been previously diagnosed with clinically significant peripheral neuropathy.
- Has any degree of permanent neurologic deficit due to the presenting spinal disease (e.g. drop foot or gait deficit).
- Has obesity defined by BMI greater than or equal to 35kg/m2.
- Has documented allergy to the materials that will be used in the surgical or any imaging procedure (e.g. titanium alloys, cobalt-chromium-molybdenum alloys and PMMA Fenestrated Screw Cement, contrast medium)
- Has overt or active bacterial infection, local or systemic, and/or potential for bacteremia.
- Has a non-correctable spontaneous or therapeutic coagulation disorder or history of coagulation disorder associated with bleeding.
- Has evolutive cardiac disease (e.g. symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia) nonreactive to medical treatment.
- Has any disease (e.g., neuromuscular disease, etc.) that would preclude the potential benefit and/or accurate clinical evaluation of the safety of the spinal implant surgery.
- Is pregnant or planning to become pregnant during the study duration.
- Is illiterate or considered vulnerable as per the Investigator's assessment (e.g., participants incapable of judgment, or participants under tutelage).
- Concurrent participation in another clinical study that may add additional safety risks and/or confound study results\*.
Key Trial Info
Start Date :
April 18 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 15 2020
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT03797144
Start Date
April 18 2019
End Date
July 15 2020
Last Update
August 24 2021
Active Locations (6)
Enter a location and click search to find clinical trials sorted by distance.
1
UZ Leuven - Campus Gasthuisberg
Leuven, Belgium, 3000
2
Tyks Surgical Hospital
Turku, Finland, 20700
3
Hôpital de la Pitié Salpétrière
Paris, France, 75651
4
Athens Medical Center
Marousi, Athens, Greece, 15125