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

Degenerative Disc Disease Clinical Trial

— ACDF  

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00485173
• Other study ID #: INFUSE® Bone Graft PEEK ACDF
• Status: Completed
• Phase: N/A
• First received: June 8, 2007
• Last updated: February 14, 2013
• Start date: June 2007
• Est. completion date: June 2012

Study information

• Verified date: December 2012
• Source: Medtronic Spinal and Biologics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 224
• Est. completion date: June 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• INCLUSION:

1. Single-level cervical degenerative disc disease (from C3-C7) requiring surgical treatment and involving intractable radiculopathy and/or myelopathy.

2. Herniated disc and/or osteophyte formation at the level to be treated that is producing symptomatic nerve root and/or spinal cord compression.

3. 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.

4. At least 18 years of age and skeletally mature at the time of surgery.

5. A preoperative Neck Disability Index (NDI) score =30.

6. A preoperative neck pain score (pain intensity + pain frequency) =8 (out of 20) based on the preoperative Neck and Arm Pain Questionnaire.

7. If a female of childbearing potential, patient is not pregnant or nursing and agrees not to become pregnant for one year following surgery.

8. Is willing and able to comply with the study plan and able to understand and sign the Patient Informed Consent Form.

Exclusion Criteria:

• EXCLUSION:

1. A cervical spinal condition other than symptomatic cervical degenerative disc disease requiring surgical treatment at the involved level.

2. Documented or diagnosed cervical instability at the target level, defined by dynamic (flexion/extension) radiographs.

3. Previous surgical intervention at the involved level.

4. Any subsequent planned/staged surgical procedure at the involved or adjacent level(s).

5. Fused level adjacent to the level to be treated.

6. Severe pathology of the facet joints of the involved vertebral bodies.

7. Has osteoporosis, osteopenia, or osteomalacia as determined by DEXA scan.

8. Presence of active malignancy or prior history of malignancy (except for basal cell carcinoma of the skin).

9. Overt or active bacterial infection, either local or systemic.

10. Insulin dependent diabetes.

11. Chronic or acute renal failure or prior history of renal disease.

12. Documented allergy or intolerance to stainless steel, titanium, titanium alloy, polyetheretherketone (PEEK), or tantalum.

13. Is mentally incompetent. (if questionable, obtain psychiatric consult.)

14. Is a prisoner.

15. Is an alcohol and/or drug abuser as defined by currently undergoing treatment for alcohol and/or drug abuse.

16. On oral or injectable steroids for 6 weeks or more at the time of enrollment.

17. A history of autoimmune disease.

18. History of exposure to injectable collagen or silicone implants.

19. History of hypersensitivity to protein pharmaceuticals (monoclonal antibodies or gamma globulins) or collagen.

20. Received any previous exposure to any/all BMPs either human or animal extraction.

21. History of allergy to bovine products.

22. History of any allergy resulting in anaphylaxis.

23. History of an endocrine or metabolic disorder known to affect osteogenesis (e.g., Paget's Disease, renal osteodystrophy, Ehlers-Danlos Syndrome, or osteogenesis imperfecta).

24. Condition that requires postoperative medications that interfere with the stability of the implant, such as steroids.

25. 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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Degenerative Disc Disease
• Intervertebral Disc Degeneration

Intervention

Device:
• INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate
All patients enrolled in this study will receive the investigational device.

Locations

Country	Name	City	State
United States	Central Texas Spine	Austin	Texas
United States	S & B Surgery Center	Beverly Hills	California
United States	Center for Sports Medcine & Orthopedics	Chattanooga	Tennessee
United States	University of Cincinnati Dept of Neurosurgery	Cincinnati	Ohio
United States	The Hughston Clinic, P.C.	Columbus	Georgia
United States	University of Kansas Medcal Center	Kansas City	Kansas
United States	Orange County Neurological Association	Laguna Hills	California
United States	Crane Creek Medical Ctr. The Back Center /Osler Medical	Melbourne	Florida
United States	Semmes Murphey Neurologic & Spine Institute	Memphis	Tennessee
United States	TriState Orthopedic Treatment Center	Norwood	Ohio
United States	Brain and Spine Center of Texas, L.L.P.	Plano	Texas
United States	Spine Institute	Shreveport	Louisiana
United States	Inland Neurosurgery & Spine Associates, P.S.	Spokane	Washington
United States	Springfield Neurological Institute	Springfield	Missouri
United States	The Washington Hospital	Washington	Pennsylvania
United States	Buffalo Neurosurgery Group	West Seneca	New York

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Spinal and Biologics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Neck Disability Index Score	The self-administered Neck Disability Index (NDI) Questionnaire was used to assess patient neck pain and ability to function. The NDI scale ranges from 0-100. The best score is 0 (no disability) and worst is 100 (maximum disability).	24 months post-operation	No
Other	Neck Pain Score	Numerical rating scales are used to evaluate neck pain intensity and frequency. Patients rate their neck pain intensity on a scale from 0-10, with a score of 0 representing "no pain" and a score of 10 representing "pain as bad as it could be." Similarly, patients record their neck pain frequency on a scale from 0-10, with a score of 0 being "pain none of the time" and a score of 10 being "pain all of the time." The total neck pain score is the sum of pain intensity and frequency scores.	24 months post-operation	No
Other	Arm Pain Score	Numerical rating scales are used to evaluate arm pain intensity and frequency. Patients rate their arm pain intensity on a scale from 0-10, with a score of 0 representing "no pain" and a score of 10 representing "pain as bad as it could be." Similarly, patients record their arm pain frequency on a scale from 0-10, with a score of 0 being "pain none of the time" and a score of 10 being "pain all of the time." The total arm pain score will be the sum of pain intensity and frequency scores.	24 months post-operation	No
Other	General Health Status -- SF-36 PCS	The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) was used to assess general health status. The SF-36 results are summarized into two components, a physical component summary (PCS) and a mental component summary (MCS). The score for PCS is between 0 and 100, with higher scores denoting better quality of life.	24 months post-operation	No
Other	General Health Status -- SF-36 MCS	The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) was used to assess general health status. The SF-36 results are summarized into two components, a physical component summary (PCS) and a mental component summary (MCS). The score for MCS is between 0 and 100, with higher scores denoting better quality of life.	24 months post-operation	No
Other	Ossification in the Region of Target Level	Ossification in the region of target level is reported as the percentage of the patients who had ossification in the region of the target level. The region of target level included the index level, the superior and inferior adjacent disc spaces, and the superior and inferior adjacent vertebral bodies.	24 months post-operation	No
Primary	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	Yes
Secondary	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	No
Secondary	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	No
Secondary	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	Yes
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Operative Time	Operative time was recorded from skin incision to wound closure.	Time of operation, approximately 1.5 hrs.	No
Secondary	Blood Loss		During the time of operation, approximately 1.5 hours.	No
Secondary	Hospital Stay		During the time of hospital stay, average of 1 day.	No
Secondary	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	Yes