Fenestrated Screw Study

NCT ID: NCT03797144

Last Updated: 2021-08-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-18
• Study Completion Date: 2020-07-15

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 indication (degenerative spinal disease and deformity) in subjects with compromised bone quality, who will receive a surgical procedure requiring posterior stabilization and/or immobilization of one or more spinal segments using CD HORIZON® Fenestrated Screw Spinal System with Fenestrated Screw Cement.

Conditions

Degenerative Spinal Disease; Deformity of Spine

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Fenestrated Screw System

Group Type: EXPERIMENTAL

CD HORIZON® Fenestrated Screw System with Fenestrated Screw Cement

Intervention Type: DEVICE

The CD HORIZON® Legacy™ and Solera™ Fenestrated Screw Spinal System consists of a variety of cannulated screws with a series of fenestrations to allow polymethylmethacrylate (PMMA) bone cement (Fenestrated Screw Cement) to be injected into the treated site. The Fenestrated Screw Cement is used to augment screw fixation in subjects with compromised bone quality.

Interventions

CD HORIZON® Fenestrated Screw System with Fenestrated Screw Cement

The CD HORIZON® Legacy™ and Solera™ Fenestrated Screw Spinal System consists of a variety of cannulated screws with a series of fenestrations to allow polymethylmethacrylate (PMMA) bone cement (Fenestrated Screw Cement) to be injected into the treated site. The Fenestrated Screw Cement is used to augment screw fixation in subjects with compromised bone quality.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. 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)

2. 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.

3. 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.

4. Requires a procedure with an instrumented, posterior thoracic and/or lumbar spinal stabilization and/or immobilization.

5. Is scheduled to receive a construct using CD Horizon® Spinal System components with at least one Fenestrated Screw cemented with Fenestrated Screw Cement.

6. At least 22 years old or greater at the time of informed consent.

7. Is able to understand and willing to sign the Patient Informed Consent Form.

8. Is willing and able to undergo the study procedure and perform the follow up visits.

Exclusion Criteria

A subject will be excluded from participating in this trial for any of the following reasons:

1. Has undergone stabilization and/or fusion procedure at the index or adjacent levels.

2. Will undergo vertebroplasty or kyphoplasty procedure during surgery.

3. Has been diagnosed with cauda equina syndrome.

4. Has been previously diagnosed with clinically significant peripheral neuropathy.

5. Has any degree of permanent neurologic deficit due to the presenting spinal disease (e.g. drop foot or gait deficit).

6. Has obesity defined by BMI greater than or equal to 35kg/m2.

7. 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)

8. Has overt or active bacterial infection, local or systemic, and/or potential for bacteremia.

9. Has a non-correctable spontaneous or therapeutic coagulation disorder or history of coagulation disorder associated with bleeding.

10. Has evolutive cardiac disease (e.g. symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia) nonreactive to medical treatment.

11. 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.

12. Is pregnant or planning to become pregnant during the study duration.

13. Is illiterate or considered vulnerable as per the Investigator's assessment (e.g., participants incapable of judgment, or participants under tutelage).

14. Concurrent participation in another clinical study that may add additional safety risks and/or confound study results*.

• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic Spinal and Biologics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

UZ Leuven - Campus Gasthuisberg

Leuven, , Belgium

Tyks Surgical Hospital

Turku, , Finland

Hôpital de la Pitié Salpétrière

Paris, , France

Athens Medical Center

Marousi, Athens, Greece

Mediterraneo Hospital

Athens, , Greece

IRCCS Istituto Clinico Humanitas di Milano

Rozzano, , Italy

Countries

Belgium; Finland; France; Greece; Italy

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

MDT17040SD1703

Identifier Type: -

Identifier Source: org_study_id