Clinical Outcomes Study Evaluating the Zero-P PEEK

NCT00945243 | Terminated Results

• 1 other identifier: ZeroP-021109
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 14

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.

Conditions

Cervical Disc Disease

Keywords

SCDD

Outcome Measures

Primary Outcomes (1)

• Assessment of Neck Disability Index Scores

  Percentage of subjects who experienced a maintenance or improvement according to measures of pain and/or function.

  24 months

Secondary Outcomes (2)

• Improvement in the Neck and Arm Visual Analog Pain Scale (VAS)

  24 months

• Implant Related Complications

  24 months

Study Arms (1)

Treatment

OTHER

Treatment of cervical DDD with the Zero-P device

Device: Zero-P

Interventions

Zero-P 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.

Also known as: Zero-P PEEK Spacer

Treatment

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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;
• 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;

Sponsors & Collaborators

• Synthes USA HQ, Inc.: lead

Study Sites (14)

Neurospine, South East Alabama Medical Center

Dothan, Alabama, 36301, United States

Location

Barrow Neurosurgical Institute

Phoenix, Arizona, 85013, United States

Location

Newport Orthopaedics, Hoag Hospital

Newport Beach, California, 92660, United States

Location

Lyerly Neurosurgery Group

Jacksonville, Florida, 32207, United States

Location

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

Indiana Spine Center

Lafayette, Indiana, 46041, United States

Location

The Boston Spine Group

Newton, Massachusetts, 02458, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Sierra Neurosurgery Group

Reno, Nevada, 89502, United States

Location

Reno Orthopaedic Clinic

Reno, Nevada, 89503, United States

Location

VSAS Orthopaedics

Allentown, Pennsylvania, 18103, United States

Location

Charleston Neurosurgical Associates

Charleston, South Carolina, 29414, United States

Location

Neurosurgery Northwest

Tacoma, Washington, 98405, United States

Location

Milwaukee Spinal Specialists

Milwaukee, Wisconsin, 53211, United States

Location

Results Point of Contact

• Title: Mark Lotito
• Organization: DePuy Synthes Spine

mlotito@its.jnj.com

508-880-8045

Study Officials

• Mark Lotito

  DePuy Synthes Assoc. Director Clinical Research

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2009
• First Posted: July 24, 2009
• Study Start: July 1, 2009
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: November 6, 2017
• Results First Posted: January 13, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (14)