Clinical Outcomes Study Evaluating the Zero-P PEEK

Cervical Disc Disease Clinical Trial

Official title:

Prospective, Multi-Center Clinical Outcomes Study Evaluating the Zero-P PEEK for Anterior Cervical Interbody Fusion in the Treatment of Cervical Degenerative Disc Disease

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00945243
• Other study ID #: ZeroP-021109
• Status: Terminated
• Phase: N/A
• First received: July 22, 2009
• Last updated: October 3, 2017
• Start date: July 1, 2009
• Est. completion date: December 1, 2011

Study information

• Verified date: September 2017
• Source: Synthes USA HQ, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This was a post-market study

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: December 1, 2011
• Est. primary completion date: December 1, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cervical Disc Disease

Intervention

Device:
• 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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Synthes USA HQ, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Improvement in the Neck and Arm Visual Analog Pain Scale (VAS)	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.	24 months
Secondary	Implant Related Complications	Percentage of subjects who had an implant related complication	24 months