Clinical trial NCT00945243: Clinical Outcomes Study Evaluating the Zero-P PEEK
Official title: Prospective, Multi-Center Clinical Outcomes Study Evaluating the Zero-P PEEK for Anterior Cervical Interbody Fusion in the Treatment of Cervical Degenerative Disc Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cervical Disc Disease
Keywords: SCDD
Lead sponsor: Synthes USA HQ, Inc.
Sponsor class: INDUSTRY
First posted: 2009-07-24
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a multi-center, prospective, outcomes study. In this study, the Zero-P PEEK implant will be used in patients undergoing ACDF for treatment of SCDD at a single level between C3 and C7. The cohort will be followed over time to twenty-four (24) months after surgery. Up to fifteen (15) sites will participate in this study. This is not a controlled study.

Detailed description: This was a post-market study

Eligibility criteria: Inclusion Criteria:

1. Symptomatic cervical disc disease (SCDD) in only one vertebral level between C3-C7 requiring:

   1. Neck or arm (radicular) pain and/or
   2. Functional/neurological deficit confirmed by imaging (CT, MRI, X-Ray) of at least one of the following:

   i. herniated nucleus pulposus

   ii. spondylosis (defined by presence of osteophytes)

   iii. loss of disc height
2. NDI score greater than or equal to 15/50 (30%) (considered moderate disability);
3. Skeletally mature adult between the ages of 18-70 years at the time of surgery;
4. Has completed at least six (6) weeks of conservative therapy;
5. Psychosocially, mentally and physically able to fully comply with this protocol including adhering to scheduled visits, treatment plan, completing forms, and other study procedures;
6. Personally signed and dated informed consent document prior to any study-related procedures indicating that the patient has been informed of all pertinent aspects of the study.

Exclusion Criteria:

1. More than one vertebral level to be fused;
2. Posterior instrumentation necessary at same level;
3. Has had previous surgery at the index level;
4. Has a fused level adjacent to the index level;
5. Active systemic or local infection;
6. Known or documented history of communicable disease, including AIDS or HIV;
7. Active hepatitis (receiving medical treatment within two years);
8. Active rheumatoid arthritis, non-controlled diabetes mellitus, or any other medical condition(s) that would represent a significant increase in surgical risk or interfere with normal healing;
9. Immunologically suppressed, or has received systemic steroids, excluding nasal steroids, at any dose daily for \> 1 month within last 12 months;
10. Known history of Paget's disease, osteomalacia, or any other metabolic bone disease;
11. Osteopenia or Osteoporosis: A screening questionnaire for osteoporosis, SCORE (Simple Calculated Osteoporosis Risk Estimation), will be used to screen patients who require a DEXA bone mineral density measurement. If DEXA is required, exclusion will be defined as a DEXA bone density measured T score ≤ -1.0.
12. Previous known allergy to the materials contained in the device, such as polyetheretherketone (PEEK) or titanium alloy (TAN);
13. Morbid obesity defined as a body mass index \> 40 kg/m2 or weight more than 100 pounds over ideal body weight;
14. Active malignancy. A patient with a history of any invasive malignancy (except non-melanoma skin cancer), unless treated with curative intent and there has been no clinical signs or symptoms of the malignancy for more than 5 years;
15. Current or recent history (within last 2 years) of substance abuse (e.g., recreational drugs, narcotics, or alcohol);
16. Pregnant or planning to become pregnant during study period;
17. Involved in study of another investigational product that may affect outcome;
18. History of psychosocial disorders that could prevent accurate completion of self reporting assessment scales;
19. Patients who are incarcerated.

Primary outcomes:
measure: Assessment of Neck Disability Index Scores
timeFrame: 24 months
Secondary outcomes:
measure: Improvement in the Neck and Arm Visual Analog Pain Scale (VAS)
timeFrame: 24 months
measure: Implant Related Complications
timeFrame: 24 months
Other outcomes:
Locations:
city: Dothan
country: United States
facility: Neurospine, South East Alabama Medical Center
state: Alabama
city: Phoenix
country: United States
facility: Barrow Neurosurgical Institute
state: Arizona
city: Newport Beach
country: United States
facility: Newport Orthopaedics, Hoag Hospital
state: California
city: Jacksonville
country: United States
facility: Lyerly Neurosurgery Group
state: Florida
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: Lafayette
country: United States
facility: Indiana Spine Center
state: Indiana
city: Newton
country: United States
facility: The Boston Spine Group
state: Massachusetts
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Reno
country: United States
facility: Sierra Neurosurgery Group
state: Nevada
city: Reno
country: United States
facility: Reno Orthopaedic Clinic
state: Nevada
city: Allentown
country: United States
facility: VSAS Orthopaedics
state: Pennsylvania
city: Charleston
country: United States
facility: Charleston Neurosurgical Associates
state: South Carolina
city: Tacoma
country: United States
facility: Neurosurgery Northwest
state: Washington
city: Milwaukee
country: United States
facility: Milwaukee Spinal Specialists
state: Wisconsin
Study officials:
affiliation: DePuy Synthes Assoc. Director Clinical Research
name: Mark Lotito
role: STUDY_DIRECTOR
References: