Fenestrated Screw Study

Medtronic Spinal and Biologics27 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Degenerative Spinal Disease Deformity of Spine

Interventions

CD HORIZON® Fenestrated Screw System with Fenestrated Screw CementDEVICE

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.

Eligibility

Sex: ALLMin age: 22 Years

Medical Language ↔ Plain English

Inclusion Criteria: A subject must meet the following inclusion criteria to participate in this trial: 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\*.

Locations (6)

UZ Leuven - Campus Gasthuisberg

Leuven, Belgium

Tyks Surgical Hospital

Turku, Finland

Hôpital de la Pitié Salpétrière

Paris, France

Athens Medical Center

Marousi, Athens, Greece

Outcomes

Primary Outcomes

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.

Time frame: Baseline to 12 months

Secondary Outcomes

Change in ODI From Baseline at 3 Months Visit

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. \[23\]. 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 19 subjects who completed the 3 months 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 time point minus the value of the 3 months time point.

Time frame: Baseline, 3 months

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

Levels of back pain and leg pain were measured using the Visual Analogue Scales (VAS). Subjects were asked to rate the amount of back pain and leg pain they have had in the last week, where 0 is no pain and 10 is the worst pain possible. The results are summarized for 21 subjects who were assessed at Baseline, 19 subjects who completed the 3 months follow up visit and 2 subjects who completed the 12month follow-up visit. The reported VAS was calculated from two timepoints as the value of the baseline point minus the value of the 3 months time point and the value of the baseline minus the value of the 12 months time point. The 24 months follow-up visit did not have data collected and are not reported.

Data from ClinicalTrials.gov

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Mediterraneo Hospital

Athens, Greece

IRCCS Istituto Clinico Humanitas di Milano

Rozzano, Italy

Time frame: Baseline, 3, 12 months

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

The EQ-5D 5L (European Quality of Life-5 Dimensions) self-report questionnaire was used to assess health-related quality of life status. The EQ-5D 5L questionnaire includes five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five levels, reflecting "no health problems," "slight health problems," "moderate health problems," "severe health problems," and "extreme health problems." The EQ-5D 5L will be used for calculating EQ-5D index score. The EQ-5D VAS was also utilized to document the subject's self-rated overall health state on a 0 to 100 scale (0 = maximal health-related problems, 100 = minimal health-related problems). EQ-5D 5L was calculated from two timepoints as the value of the baseline point minus the value of the 3 months follow-up visit and the value of the baseline point minus the value of the 12 months follow-up visit. The 24 months follow-up visit did not have data collected and are not reported.

Time frame: Baseline, 3, 12 months

Rate of Neurological Success at 12-month Visit

Neurological status is based on 4 sections: motor, sensory, reflexes, and straight leg raising, each comprising several elements. Following scales were used to evaluate neurological status: reflexes (0 = Absent or Trace, 1 = Hyper-reflexic, 2 = Normal), sensory function (Light Touch or Pin Prick L1 to S1; 1 = Absent, 2 = Impaired, 3 = Normal), motor function (using 0-5 scores 0-5 whereas 0= Total Paralysis, 1 = Palpable or Visible Contraction, 2 = Active Movement, Gravity Eliminated, 3 = Active Movement, Against Gravity, 4 = Active Movement, Against Some Resistance and 5 = Active Movement, Against Full Resistance (full strength) and straight leg raise (1 = Positive. Patient experiences radiating leg pain below the knee on elevating the leg between 15° and 70° with the knee extended, 2 = Negative. No pain experienced). Overall neurological success will be defined as maintenance or improvement in all sections for time period evaluated (each element must remain the same or improve).

Time frame: Baseline to 12 months.

Rate of Intraoperative Cement Extravasation/Leakage. Patients

The rate of intraoperative cement extravasation/leakage as directly assessed by the physician during the surgery or in the post-operative follow-up with imaging procedures.