Clinical Outcomes Study Evaluating the Zero-P PEEK

Stopped early · Not applicable

Conditions studied: Cervical Disc Disease

In brief

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.

Key facts

Study ID

NCT00945243

Run by

Synthes USA HQ, Inc.

People needed

11

Starts

2009-07-01

Expected to finish

2011-12-01

Last updated by the study team

2017-11-06

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Neurospine, South East Alabama Medical Center — Dothan, Alabama, United States
• Barrow Neurosurgical Institute — Phoenix, Arizona, United States
• Newport Orthopaedics, Hoag Hospital — Newport Beach, California, United States
• Lyerly Neurosurgery Group — Jacksonville, Florida, United States
• Northwestern Memorial Hospital — Chicago, Illinois, United States
• Indiana Spine Center — Lafayette, Indiana, United States
• The Boston Spine Group — Newton, Massachusetts, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Sierra Neurosurgery Group — Reno, Nevada, United States
• Reno Orthopaedic Clinic — Reno, Nevada, United States
• VSAS Orthopaedics — Allentown, Pennsylvania, United States
• Charleston Neurosurgical Associates — Charleston, South Carolina, United States
• Neurosurgery Northwest — Tacoma, Washington, United States
• Milwaukee Spinal Specialists — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.