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Trial record 7 of 5959 for:    zero

Clinical Outcomes Study Evaluating the Zero-P PEEK

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ClinicalTrials.gov Identifier: NCT00945243
Recruitment Status : Terminated (This study was terminated early due to lower than expected enrollment rates.)
First Posted : July 24, 2009
Results First Posted : January 13, 2017
Last Update Posted : November 6, 2017
Sponsor:
Information provided by (Responsible Party):
Synthes USA HQ, Inc.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Cervical Disc Disease
Intervention Device: Zero-P
Enrollment 11
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment
Hide 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 [1]
Completed 8
Not Completed 3
Reason Not Completed
Study Terminated: Subjects Dispositioned             3
[1]
Enrolled and Treated Per Protocol
Arm/Group Title Treatment
Hide 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 Number of Baseline Participants 11
Hide Baseline Analysis Population Description
Number of subjects enrolled and treated per protocol
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 11 participants
47.8  (11.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
Female
7
  63.6%
Male
4
  36.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 11 participants
11
1.Primary Outcome
Title Assessment of Neck Disability Index Scores
Hide Description Percentage of subjects who experienced a maintenance or improvement according to measures of pain and/or function.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
8 subjects had data at 24 months
Arm/Group Title Treatment
Hide 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 Number of Participants Analyzed 8
Measure Type: Number
Unit of Measure: percentage of subjects
87.5
2.Secondary Outcome
Title Improvement in the Neck and Arm Visual Analog Pain Scale (VAS)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
8 subjects had data at 24 months.
Arm/Group Title Treatment
Hide 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 Number of Participants Analyzed 8
Measure Type: Number
Unit of Measure: percentage of subjects
75.0
3.Secondary Outcome
Title Implant Related Complications
Hide Description Percentage of subjects who had an implant related complication
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
11 subjects were enrolled and treated on protocol and were thus considered for safety information
Arm/Group Title Treatment
Hide 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 Number of Participants Analyzed 11
Measure Type: Number
Unit of Measure: percentage of subjects
0
Time Frame From enrollment out to 24 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment
Hide 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 (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Treatment
Affected / at Risk (%) # Events
Total   0/11 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Treatment
Affected / at Risk (%) # Events
Total   3/11 (27.27%)    
Immune system disorders   
Cold Symptoms   1/11 (9.09%)  1
Nervous system disorders   
Pain and/or Weakness   3/11 (27.27%)  3
Seizure   1/11 (9.09%)  1
Surgical and medical procedures   
Adjacent Level Surgery   1/11 (9.09%)  1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Mark Lotito
Organization: DePuy Synthes Spine
Phone: 508-880-8045
Responsible Party: Synthes USA HQ, Inc.
ClinicalTrials.gov Identifier: NCT00945243     History of Changes
Other Study ID Numbers: ZeroP-021109
First Submitted: July 22, 2009
First Posted: July 24, 2009
Results First Submitted: November 17, 2016
Results First Posted: January 13, 2017
Last Update Posted: November 6, 2017