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Clinical Outcomes Study Evaluating the Zero-P PEEK

Primary Purpose

Cervical Disc Disease

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Zero-P
Sponsored by
Synthes USA HQ, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Disc Disease focused on measuring SCDD

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Neurospine, South East Alabama Medical Center
  • Barrow Neurosurgical Institute
  • Newport Orthopaedics, Hoag Hospital
  • Lyerly Neurosurgery Group
  • Northwestern Memorial Hospital
  • Indiana Spine Center
  • The Boston Spine Group
  • Washington University School of Medicine
  • Sierra Neurosurgery Group
  • Reno Orthopaedic Clinic
  • VSAS Orthopaedics
  • Charleston Neurosurgical Associates
  • Neurosurgery Northwest
  • Milwaukee Spinal Specialists

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Treatment

Arm Description

Treatment of cervical DDD with the Zero-P device

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
Implant Related Complications
Percentage of subjects who had an implant related complication

Full Information

First Posted
July 22, 2009
Last Updated
October 3, 2017
Sponsor
Synthes USA HQ, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00945243
Brief Title
Clinical Outcomes Study Evaluating the Zero-P PEEK
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Terminated
Why Stopped
This study was terminated early due to lower than expected enrollment rates.
Study Start Date
July 1, 2009 (Actual)
Primary Completion Date
December 1, 2011 (Actual)
Study Completion Date
December 1, 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Synthes USA HQ, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Disc Disease
Keywords
SCDD

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Other
Arm Description
Treatment of cervical DDD with the Zero-P device
Intervention Type
Device
Intervention Name(s)
Zero-P
Other Intervention Name(s)
Zero-P PEEK Spacer
Intervention Description
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.
Primary Outcome Measure Information:
Title
Assessment of Neck Disability Index Scores
Description
Percentage of subjects who experienced a maintenance or improvement according to measures of pain and/or function.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Improvement in the Neck and Arm Visual Analog Pain Scale (VAS)
Description
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.
Time Frame
24 months
Title
Implant Related Complications
Description
Percentage of subjects who had an implant related complication
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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; 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. 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; Involved in study of another investigational product that may affect outcome; History of psychosocial disorders that could prevent accurate completion of self reporting assessment scales; Patients who are incarcerated.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Lotito
Organizational Affiliation
DePuy Synthes Assoc. Director Clinical Research
Official's Role
Study Director
Facility Information:
Facility Name
Neurospine, South East Alabama Medical Center
City
Dothan
State/Province
Alabama
ZIP/Postal Code
36301
Country
United States
Facility Name
Barrow Neurosurgical Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Newport Orthopaedics, Hoag Hospital
City
Newport Beach
State/Province
California
ZIP/Postal Code
92660
Country
United States
Facility Name
Lyerly Neurosurgery Group
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
Northwestern Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Indiana Spine Center
City
Lafayette
State/Province
Indiana
ZIP/Postal Code
46041
Country
United States
Facility Name
The Boston Spine Group
City
Newton
State/Province
Massachusetts
ZIP/Postal Code
02458
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Sierra Neurosurgery Group
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502
Country
United States
Facility Name
Reno Orthopaedic Clinic
City
Reno
State/Province
Nevada
ZIP/Postal Code
89503
Country
United States
Facility Name
VSAS Orthopaedics
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Facility Name
Charleston Neurosurgical Associates
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29414
Country
United States
Facility Name
Neurosurgery Northwest
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Milwaukee Spinal Specialists
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53211
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Clinical Outcomes Study Evaluating the Zero-P PEEK

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