Clinical Outcomes Study Evaluating the Zero-P PEEK

Not Applicable

Terminated

• Conditions: Cervical Disc Disease
• Interventions: Device: Zero-P

• Registration Number: NCT00945243
• Lead Sponsor: Synthes USA HQ, Inc.

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

Study Timeline

• Study Start: 2009-07-01
• Study First Submitted: 2009-07-22
• Study First Submitted QC: 2009-07-23
• Study First Posted: 2009-07-24
• Primary Completion: 2011-12-01
• Study Completion: 2011-12-01
• Results First Submitted: 2016-11-17
• Results First Submitted QC: 2016-11-17
• Results First Posted: 2017-01-13
• Status Verified: 2017-09
• Last Update Submitted: 2017-10-03
• Last Update Posted: 2017-11-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 11

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	Zero-P	Treatment of cervical DDD with the Zero-P device

Primary Outcome Measures

Name	Time	Method
Assessment of Neck Disability Index Scores	24 months	Percentage of subjects who experienced a maintenance or improvement according to measures of pain and/or function.

Secondary Outcome Measures

Name	Time	Method
Implant Related Complications	24 months	Percentage of subjects who had an implant related complication
Improvement in the Neck and Arm Visual Analog Pain Scale (VAS)	24 months	Percentage of subjects who experienced a maintenance of improvement in VAS neck pain intensity, neck pain frequency, arm pain intensity, and/or arm pain frequency.

Trial Locations

Locations (14)

Neurospine, South East Alabama Medical Center; 🇺🇸 Dothan, Alabama, United States

Newport Orthopaedics, Hoag Hospital; 🇺🇸 Newport Beach, California, United States

Lyerly Neurosurgery Group; 🇺🇸 Jacksonville, Florida, United States

Indiana Spine Center; 🇺🇸 Lafayette, Indiana, United States

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States

VSAS Orthopaedics; 🇺🇸 Allentown, Pennsylvania, United States

Neurosurgery Northwest; 🇺🇸 Tacoma, Washington, United States

Barrow Neurosurgical Institute; 🇺🇸 Phoenix, Arizona, United States

Northwestern Memorial Hospital; 🇺🇸 Chicago, Illinois, United States

Sierra Neurosurgery Group; 🇺🇸 Reno, Nevada, United States

Reno Orthopaedic Clinic; 🇺🇸 Reno, Nevada, United States

Charleston Neurosurgical Associates; 🇺🇸 Charleston, South Carolina, United States

The Boston Spine Group; 🇺🇸 Newton, Massachusetts, United States

Milwaukee Spinal Specialists; 🇺🇸 Milwaukee, Wisconsin, United States