INFUSE® Bone Graft/ PEEK Interbody Spacer/ Anterior Cervical Plate Pivotal Clinical Trial

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety and effectiveness of the investigational implant (INFUSE® Bone Graft/PEEK Interbody Spacer/Anterior Cervical Plate) as a method of facilitating spinal fusion at a single level from C3-C7 in patients with symptomatic cervical degenerative disc disease.

Detailed Description
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This pivotal clinical trial is being conducted to evaluate the safety and effectiveness of INFUSE® Bone Graft with the PEEK Interbody Spacer and Anterior Cervical Plate in patients with symptomatic cervical degenerative disc disease (DDD). The implant under investigation in this clinical trial is INFUSE® Bone Graft, the PEEK Interbody Spacer, and Anterior Cervical Plate. The device will be implanted using an anterior surgical approach. Safety and effectiveness data for patients in this study will be compared to that of historical controls. Historical control data will be taken from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).

Official Title
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A Pivotal Clinical Investigation of INFUSE® Bone Graft With a PEEK Interbody Spacer and an Anterior Cervical Plate in Patients With Cervical Degenerative Disc Disease at a Single Level.

Conditions
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Degenerative Disc Disease

Intervention / Treatment
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* Device: INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: INCLUSION: Single-level cervical degenerative disc disease (from C3-C7) requiring surgical treatment and involving intractable radiculopathy and/or myelopathy. Herniated disc and/or osteophyte formation at the level to be treated that is producing symptomatic nerve root and/or spinal cord compression. Unresponsive to non-operative treatment for six weeks or has the presence of progressive symptoms or signs of nerve root/spinal cord compression in the face of continued non-operative management. At least 18 years of age and skeletally mature at the time of surgery. A preoperative Neck Disability Index (NDI) score ≥30. A preoperative neck pain score (pain intensity + pain frequency) ≥8 (out of 20) based on the preoperative Neck and Arm Pain Questionnaire. If a female of childbearing potential, patient is not pregnant or nursing and agrees not to become pregnant for one year following surgery. Is willing and able to comply with the study plan and able to understand and sign the Patient Informed Consent Form. Exclusion Criteria: EXCLUSION: A cervical spinal condition other than symptomatic cervical degenerative disc disease requiring surgical treatment at the involved level. Documented or diagnosed cervical instability at the target level, defined by dynamic (flexion/extension) radiographs. Previous surgical intervention at the involved level. Any subsequent planned/staged surgical procedure at the involved or adjacent level(s). Fused level adjacent to the level to be treated. Severe pathology of the facet joints of the involved vertebral bodies. Has osteoporosis, osteopenia, or osteomalacia as determined by DEXA scan. Presence of active malignancy or prior history of malignancy (except for basal cell carcinoma of the skin). Overt or active bacterial infection, either local or systemic. Insulin dependent diabetes. Chronic or acute renal failure or prior history of renal disease. Documented allergy or intolerance to stainless steel, titanium, titanium alloy, polyetheretherketone (PEEK), or tantalum. Is mentally incompetent. (if questionable, obtain psychiatric consult.) Is a prisoner. Is an alcohol and/or drug abuser as defined by currently undergoing treatment for alcohol and/or drug abuse. On oral or injectable steroids for 6 weeks or more at the time of enrollment. A history of autoimmune disease. History of exposure to injectable collagen or silicone implants. History of hypersensitivity to protein pharmaceuticals (monoclonal antibodies or gamma globulins) or collagen. Received any previous exposure to any/all BMPs either human or animal extraction. History of allergy to bovine products. History of any allergy resulting in anaphylaxis. History of an endocrine or metabolic disorder known to affect osteogenesis (e.g., Paget's Disease, renal osteodystrophy, Ehlers-Danlos Syndrome, or osteogenesis imperfecta). Condition that requires postoperative medications that interfere with the stability of the implant, such as steroids. Received treatment with an investigational therapy (drug, device, or biologic) within 28 days prior to implantation surgery or such treatment is planned during the 24-month period following the study surgery.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: INFUSE® Bone Graft<br>In this arm, patients will receive implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate. | Device: INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate<br>* All patients enrolled in this study will receive the investigational device.<br>* Other names: ACDF, Anterior Cervical Plate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Overall Success | Rate of overall success is reported as the percentage of participants who met all of the following criteria: fusion at the treated level; pain/disability (Neck Disability Index) success; neurological status success; no serious adverse event classified as implant associated or implant/surgical procedure associated; no additional surgical procedure classified as a failure. | 24 months post-operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success Rate of Fusion | Success Rate of Fusion is reported as percent of participants who met the following fusion criteria: Evidence of bridging bone. This is based on the evidence of a continuous bony connection from the superior vertebral body to the inferior vertebral body in at least one of the following areas: lateral, anterior, posterior and/or through the PEEK spacer. No evidence of radiolucency at greater than 50% of the superior or inferior PEEK spacer-vertebra interface. No evidence of motion as defined by ≤ 4º of angular motion (based on flexion-extension lateral plain radiographs). | 24 months post-operation | 
| Success Rate of Neck Disability Index | Success rate of Neck Disability Index is reported as the percentage of participants whose neck disability index score met: Pre-treatment Score - Post-treatment Score ≥ 15. | 24 months post-operation | 
| Success Rate of Neurological Status | Success rate of neurological status is reported as the percentage of participants who met neurological success defined as maintenance or improvement in all sections (motor, sensory, and reflexes) for the time period evaluated. In order for a section to be considered a success, each element in the section must remain the same or improve from the time of the preoperative evaluation to the time period evaluated. | 24 months post-operation | 
| Neck Pain Success Rate | Neck pain success rate is reported as the percentage of participants whose neck pain improvement met: Preoperative Score - Postoperative Score > 0. | 24 months post-operation | 
| Arm Pain Success Rate | Arm pain success rate is reported as the percentage of participants whose arm pain improvement met: Preoperative Score - Postoperative Score > 0. | 24 months post-operation | 
| Success Rate of SF-36 PCS | Success rate of SF-36 Health Survey include two components: the success rate of a physical component summary (PCS) and the success rate of a mental component summary (MCS). The success rate of SF-36 PCS was defined as: Post Score - Pre Score >= 0. | 24 months post-operation | 
| Success Rate of SF-36 MCS | Success rate of SF-36 Health Survey include two components: the success rate of a physical component summary (PCS) and the success rate of a mental component summary (MCS). The success rates of SF-36 MCS were defined as: Post Score - Pre Score >= 0. | 24 months post-operation | 
| Operative Time | Operative time was recorded from skin incision to wound closure. | Time of operation, approximately 1.5 hrs. | 
| Blood Loss |  | During the time of operation, approximately 1.5 hours. | 
| Hospital Stay |  | During the time of hospital stay, average of 1 day. | 
| Number of Patients Who Had Secondary Surgeries at the Index Level | Secondary surgical procedures at the index level included revisions, removal, supplemental fixation and reoperations. | 24 months post-operation |