Clinical Outcomes Study Evaluating the Zero-P PEEK

DePuy Synthes

Status: Terminated

Conditions: Cervical Disc Disease

Treatments: Device: Zero-P

Study type: Interventional

Funder types: Industry

Identifiers

NCT00945243

ZeroP-021109

Details and patient eligibility

About

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.

Full description

This was a post-market study

Enrollment: 11 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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11 participants in 1 patient group

Treatment

Other group

Description:

Treatment of cervical DDD with the Zero-P device

Treatment:

Device: Zero-P