Fenestrated Screw Study

NCT03797144 | Terminated Results FDA Device

• 1 other identifier: MDT17040SD1703
• Study Type: interventional
• Target: 27
• Locations: 5 countries
• Sites: 6

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

Outcome Measures

Primary Outcomes (1)

• Change in ODI (Oswestry Disability Index) at 12 Months Compared to Baseline

  Disability associated with thoracic/lumbar spine conditions was assessed using the Oswestry Low Back Pain Disability Questionnaire, which yields the Oswestry Disability Index (ODI), Version 2.1a.This validated instrument is considered one of the principal condition-specific outcome measures used in the management of spinal disorders. ODI is composed by 10 sections. Each section can be scored 0 to 5, 5 being the worst case. The score is calculated by summing the different sections and then doubling the total. Maximum score is 100. The results are summarized for 21 subjects who were assessed at Baseline and 2 subjects who completed the 12 month follow-up visit. The 24 months follow-up visit did not have data collected and are not reported. The reported ODI was calculated from two timepoints as the value of the baseline point minus the value of the 12 months time point.

  Baseline to 12 months

Secondary Outcomes (13)

• Change in ODI From Baseline at 3 Months Visit

  Baseline, 3 months

• Change in VAS (Visual Analogue Scale) Back and Leg Pain Score at 3 and 12 Months Follow-up Visit From Baseline

  Baseline, 3, 12 months

• Change in EQ-5D 5L (European Quality of Life-5 Dimensions) at 3 and 12 Months From Baseline

  Baseline, 3, 12 months

• Rate of Neurological Success at 12-month Visit

  Baseline to 12 months.

• Rate of Intraoperative Cement Extravasation/Leakage. Patients

  Surgery to 12 months.

Study Arms (1)

Fenestrated Screw System

EXPERIMENTAL

Device: CD HORIZON® Fenestrated Screw System with Fenestrated Screw Cement

Interventions

CD HORIZON® Fenestrated Screw System with Fenestrated Screw Cement 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.

Fenestrated Screw System

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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\*.

Sponsors & Collaborators

• Medtronic Spinal and Biologics: lead

Study Sites (6)

UZ Leuven - Campus Gasthuisberg

Leuven, 3000, Belgium

Location

Tyks Surgical Hospital

Turku, 20700, Finland

Location

Hôpital de la Pitié Salpétrière

Paris, 75651, France

Location

Athens Medical Center

Marousi, Athens, 15125, Greece

Location

Mediterraneo Hospital

Athens, 16675, Greece

Location

IRCCS Istituto Clinico Humanitas di Milano

Rozzano, 20086, Italy

Location

Results Point of Contact

• Title: Clinical Research Specialist
• Organization: Medtronic

francesca.molineris@medtronic.com

+39 3450225929

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2018
• First Posted: January 9, 2019
• Study Start: April 18, 2019
• Primary Completion: July 15, 2020
• Study Completion: July 15, 2020
• Last Updated: August 24, 2021
• Results First Posted: August 24, 2021

Record last verified: 2021-07

Locations

GR (2); BE (1); FI (1); IT (1); FR (1)