Status:
TERMINATED
Clinical Outcomes Study Evaluating the Zero-P PEEK
Lead Sponsor:
Synthes USA HQ, Inc.
Conditions:
Cervical Disc Disease
Eligibility:
All Genders
18-70 years
Phase:
NA
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 coho...
Detailed Description
This was a post-market study
Eligibility Criteria
Inclusion
- Symptomatic cervical disc disease (SCDD) in only one vertebral level between C3-C7 requiring:
- Neck or arm (radicular) pain and/or
- 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
- NDI score greater than or equal to 15/50 (30%) (considered moderate disability);
- Skeletally mature adult between the ages of 18-70 years at the time of surgery;
- Has completed at least six (6) weeks of conservative therapy;
- Psychosocially, mentally and physically able to fully comply with this protocol including adhering to scheduled visits, treatment plan, completing forms, and other study procedures;
- 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
- More than one vertebral level to be fused;
- Posterior instrumentation necessary at same level;
- Has had previous surgery at the index level;
- Has a fused level adjacent to the index level;
- Active systemic or local infection;
- Known or documented history of communicable disease, including AIDS or HIV;
- Active hepatitis (receiving medical treatment within two years);
- 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;
- Immunologically suppressed, or has received systemic steroids, excluding nasal steroids, at any dose daily for \> 1 month within last 12 months;
- Known history of Paget's disease, osteomalacia, or any other metabolic bone disease;
- 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.
- Previous known allergy to the materials contained in the device, such as polyetheretherketone (PEEK) or titanium alloy (TAN);
- Morbid obesity defined as a body mass index \> 40 kg/m2 or weight more than 100 pounds over ideal body weight;
- 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;
- Current or recent history (within last 2 years) of substance abuse (e.g., recreational drugs, narcotics, or alcohol);
- Pregnant or planning to become pregnant during study period;
- Involved in study of another investigational product that may affect outcome;
- History of psychosocial disorders that could prevent accurate completion of self reporting assessment scales;
- Patients who are incarcerated.
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT00945243
Start Date
July 1 2009
End Date
December 1 2011
Last Update
November 6 2017
Active Locations (14)
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1
Neurospine, South East Alabama Medical Center
Dothan, Alabama, United States, 36301
2
Barrow Neurosurgical Institute
Phoenix, Arizona, United States, 85013
3
Newport Orthopaedics, Hoag Hospital
Newport Beach, California, United States, 92660
4
Lyerly Neurosurgery Group
Jacksonville, Florida, United States, 32207