Clinical Outcomes Study Evaluating the Zero-P PEEK

• Sponsor: Synthes USA HQ, Inc. (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT00945243
• Collaborator: (none)
• Enrollment: 11
• Locations: 14
• Arm: 1
• Actual Duration (Months): 29
• Patients Per Site: 0.8
• Patients Per Site Per Month: 0

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Cervical Disc Disease	Device: Zero-P	N/A

Detailed Description

This was a post-market study

Study Design

• Study Type: Interventional
• Actual Enrollment: 11 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Jul 1, 2009
• Actual Primary Completion Date: Dec 1, 2011
• Actual Study Completion Date: Dec 1, 2011

Arms and Interventions

Arm

Intervention/Treatment

Other: Treatment Treatment of cervical DDD with the Zero-P device

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.; Other Names: Zero-P PEEK Spacer

Outcome Measures

Primary Outcome Measures

1. Assessment of Neck Disability Index Scores [24 months]

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

Secondary Outcome Measures

1. Improvement in the Neck and Arm Visual Analog Pain Scale (VAS) [24 months]

   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.

2. Implant Related Complications [24 months]

   Percentage of subjects who had an implant related complication

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Symptomatic cervical disc disease (SCDD) in only one vertebral level between C3-C7 requiring:

2. Neck or arm (radicular) pain and/or

3. Functional/neurological deficit confirmed by imaging (CT, MRI, X-Ray) of at least one of the following:

1. herniated nucleus pulposus

1. spondylosis (defined by presence of osteophytes)

2. loss of disc height

1. NDI score greater than or equal to 15/50 (30%) (considered moderate disability);

2. Skeletally mature adult between the ages of 18-70 years at the time of surgery;

3. Has completed at least six (6) weeks of conservative therapy;

4. Psychosocially, mentally and physically able to fully comply with this protocol including adhering to scheduled visits, treatment plan, completing forms, and other study procedures;

5. 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Neurospine, South East Alabama Medical Center	Dothan	Alabama	United States	36301
2	Barrow Neurosurgical Institute	Phoenix	Arizona	United States	85013
3	Newport Orthopaedics, Hoag Hospital	Newport Beach	California	United States	92660
4	Lyerly Neurosurgery Group	Jacksonville	Florida	United States	32207
5	Northwestern Memorial Hospital	Chicago	Illinois	United States	60611
6	Indiana Spine Center	Lafayette	Indiana	United States	46041
7	The Boston Spine Group	Newton	Massachusetts	United States	02458
8	Washington University School of Medicine	Saint Louis	Missouri	United States	63110
9	Sierra Neurosurgery Group	Reno	Nevada	United States	89502
10	Reno Orthopaedic Clinic	Reno	Nevada	United States	89503
11	VSAS Orthopaedics	Allentown	Pennsylvania	United States	18103
12	Charleston Neurosurgical Associates	Charleston	South Carolina	United States	29414
13	Neurosurgery Northwest	Tacoma	Washington	United States	98405
14	Milwaukee Spinal Specialists	Milwaukee	Wisconsin	United States	53211

Sponsors and Collaborators

• Synthes USA HQ, Inc.

Investigators

• Study Director: Mark Lotito, DePuy Synthes Assoc. Director Clinical Research

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Synthes USA HQ, Inc.
• ClinicalTrials.gov Identifier: NCT00945243
• Other Study ID Numbers: ZeroP-021109
• First Posted: Jul 24, 2009
• Last Update Posted: Nov 6, 2017
• Last Verified: Sep 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Synthes USA HQ, Inc.: SCDD
• Additional relevant MeSH terms: Spinal Diseases

Study Results

Participant Flow

Arm/Group Title	Treatment
Arm/Group Description	Treatment of cervical DDD with the Zero-P device ACDF: 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.
Period Title: Overall Study
STARTED	11
COMPLETED	8
NOT COMPLETED	3

Baseline Characteristics

Arm/Group Title	Treatment
Arm/Group Description	Treatment of cervical DDD with the Zero-P device ACDF: 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.
Overall Participants	11
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	47.8 (11.6)
Sex: Female, Male (Count of Participants)
Female	7 63.6%
Male	4 36.4%
Region of Enrollment (participants) [Number]
United States	11 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

8 subjects had data at 24 months

Arm/Group Title	Treatment
Arm/Group Description	Treatment of cervical DDD with the Zero-P device ACDF: 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.
Measure Participants	8
Number [percentage of subjects]	87.5

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

8 subjects had data at 24 months.

Arm/Group Title	Treatment
Arm/Group Description	Treatment of cervical DDD with the Zero-P device ACDF: 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.
Measure Participants	8
Number [percentage of subjects]	75.0

3. Secondary Outcome

Title	Implant Related Complications
Description	Percentage of subjects who had an implant related complication
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

11 subjects were enrolled and treated on protocol and were thus considered for safety information

Arm/Group Title	Treatment
Arm/Group Description	Treatment of cervical DDD with the Zero-P device ACDF: 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.
Measure Participants	11
Number [percentage of subjects]	0

Adverse Events

Time Frame	From enrollment out to 24 months
Arm/Group Title	Treatment
Arm/Group Description	Treatment of cervical DDD with the Zero-P device ACDF: 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.
All Cause Mortality
	Treatment
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Treatment
	Affected / at Risk (%)	# Events
Total	0/11 (0%)
Other (Not Including Serious) Adverse Events
	Treatment
	Affected / at Risk (%)	# Events
Total	3/11 (27.3%)
Immune system disorders
Cold Symptoms	1/11 (9.1%)	1
Nervous system disorders
Pain and/or Weakness	3/11 (27.3%)	3
Seizure	1/11 (9.1%)	1
Surgical and medical procedures
Adjacent Level Surgery	1/11 (9.1%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.