Clinical trial NCT00485173: INFUSE® Bone Graft/ PEEK Interbody Spacer/ Anterior Cervical Plate Pivotal Clinical Trial
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Degenerative Disc Disease
Lead sponsor: Medtronic Spinal and Biologics
Sponsor class: INDUSTRY
First posted: 2007-06-12
Enrollment: 224
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Rate of Overall Success
timeFrame: 24 months post-operation
Secondary outcomes:
measure: Success Rate of Fusion
timeFrame: 24 months post-operation
measure: Success Rate of Neck Disability Index
timeFrame: 24 months post-operation
measure: Success Rate of Neurological Status
timeFrame: 24 months post-operation
measure: Neck Pain Success Rate
timeFrame: 24 months post-operation
measure: Arm Pain Success Rate
timeFrame: 24 months post-operation
measure: Success Rate of SF-36 PCS
timeFrame: 24 months post-operation
measure: Success Rate of SF-36 MCS
timeFrame: 24 months post-operation
measure: Operative Time
timeFrame: Time of operation, approximately 1.5 hrs.
measure: Blood Loss
timeFrame: During the time of operation, approximately 1.5 hours.
measure: Hospital Stay
timeFrame: During the time of hospital stay, average of 1 day.
measure: Number of Patients Who Had Secondary Surgeries at the Index Level
timeFrame: 24 months post-operation
Other outcomes:
measure: Neck Disability Index Score
timeFrame: 24 months post-operation
measure: Neck Pain Score
timeFrame: 24 months post-operation
measure: Arm Pain Score
timeFrame: 24 months post-operation
measure: General Health Status -- SF-36 PCS
timeFrame: 24 months post-operation
measure: General Health Status -- SF-36 MCS
timeFrame: 24 months post-operation
measure: Ossification in the Region of Target Level
timeFrame: 24 months post-operation
Locations:
city: Beverly Hills
country: United States
facility: S & B Surgery Center
state: California
city: Laguna Hills
country: United States
facility: Orange County Neurological Association
state: California
city: Melbourne
country: United States
facility: Crane Creek Medical Ctr. The Back Center /Osler Medical
state: Florida
city: Columbus
country: United States
facility: The Hughston Clinic, P.C.
state: Georgia
city: Kansas City
country: United States
facility: University of Kansas Medcal Center
state: Kansas
city: Shreveport
country: United States
facility: Spine Institute
state: Louisiana
city: Springfield
country: United States
facility: Springfield Neurological Institute
state: Missouri
city: West Seneca
country: United States
facility: Buffalo Neurosurgery Group
state: New York
city: Cincinnati
country: United States
facility: University of Cincinnati Dept of Neurosurgery
state: Ohio
city: Norwood
country: United States
facility: TriState Orthopedic Treatment Center
state: Ohio
city: Washington
country: United States
facility: The Washington Hospital
state: Pennsylvania
city: Chattanooga
country: United States
facility: Center for Sports Medcine & Orthopedics
state: Tennessee
city: Memphis
country: United States
facility: Semmes Murphey Neurologic & Spine Institute
state: Tennessee
city: Austin
country: United States
facility: Central Texas Spine
state: Texas
city: Plano
country: United States
facility: Brain and Spine Center of Texas, L.L.P.
state: Texas
city: Spokane
country: United States
facility: Inland Neurosurgery & Spine Associates, P.S.
state: Washington
Study officials:
References: