Clinical Outcomes Study Evaluating the Zero-P PEEK

NCT ID: NCT00945243

Last Updated: 2017-11-06

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-07-01
• Study Completion Date: 2011-12-01

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

Conditions

Cervical Disc Disease

Keywords

SCDD

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment

Treatment of cervical DDD with the Zero-P device

Group Type: OTHER

Zero-P

Intervention Type: DEVICE

The Zero-P PEEK is a stand-alone device intended for use in cervical interbody fusion. The device consists of a plate and a spacer with four rigid screws to provide similar stability to a traditional cervical plate and interbody spacer. It is intended for use in skeletally mature patients with symptomatic cervical disc disease (SCDD) with accompanying radicular symptoms, at one level from C3 to C7.

Interventions

Zero-P

The Zero-P PEEK is a stand-alone device intended for use in cervical interbody fusion. The device consists of a plate and a spacer with four rigid screws to provide similar stability to a traditional cervical plate and interbody spacer. It is intended for use in skeletally mature patients with symptomatic cervical disc disease (SCDD) with accompanying radicular symptoms, at one level from C3 to C7.

Intervention Type: DEVICE

Other Intervention Names

Zero-P PEEK Spacer

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Synthes USA HQ, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark Lotito

Role: STUDY_DIRECTOR

DePuy Synthes Assoc. Director Clinical Research

Locations

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

Countries

United States

Other Identifiers

ZeroP-021109

Identifier Type: -

Identifier Source: org_study_id