Trial Evaluating the Safety and Effectiveness of NUBAC™ Disc Arthroplasty

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pioneer Surgical Technology, Inc.
ClinicalTrials.gov Identifier:
NCT00931515
First received: June 29, 2009
Last updated: May 14, 2014
Last verified: May 2014
Results First Received: April 15, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Condition: Degenerative Disc Disease
Interventions: Device: NuBac
Device: Prodisc-L

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were enrolled from February 2009 to December 2010. Patients were recruited from the medical practices of the Investigators. Enrollment was stopped in December 2010 due to the slow enrollment rate. A total of 30 subjects participated in the study; the protocol was intended for 440 patients.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Two patients were enrolled in the study and received a patient identification number, but were never randomized to a treatment group and never implanted with the device. One patient decided not to participate prior to randomization. The second patient did not meet all inclusion/exclusion criteria.

Reporting Groups
  Description
NuBac The NUBAC® disc arthroplasty system.
ProDisc The ProDisc® total disc replacement system.

Participant Flow:   Overall Study
    NuBac     ProDisc  
STARTED     15     15  
COMPLETED     13     10  
NOT COMPLETED     2     5  
Lost to Follow-up                 2                 5  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
NuBac The NUBAC® disc arthroplasty system.
ProDisc The ProDisc® total disc replacement system.
Total Total of all reporting groups

Baseline Measures
    NuBac     ProDisc     Total  
Number of Participants  
[units: participants]
  15     15     30  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     14     15     29  
>=65 years     1     0     1  
Age  
[units: years]
Mean ± Standard Deviation
  44.0  ± 11.2     40.1  ± 11.2     42.05  ± 11.2  
Gender  
[units: participants]
     
Female     10     5     15  
Male     5     10     15  
Region of Enrollment  
[units: participants]
     
United States     15     15     30  



  Outcome Measures

1.  Primary:   Participants With Improved Patient Function   [ Time Frame: 24 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Because the study was stopped after a total of 30 patients, demonstration of non-inferiority was impossible. Results from the 2 groups were compared using the Fisher exact test for categorical variables and ANOVA for continuous variables.


  More Information
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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.
The agreement is:
unchecked 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.
unchecked 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 more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Director of Regulatory and Clinical Affairs
Organization: Pioneer Surgical Technology
phone: 906-225-5602
e-mail: emilydowns@pioneersurgical.com


No publications provided


Responsible Party: Pioneer Surgical Technology, Inc.
ClinicalTrials.gov Identifier: NCT00931515     History of Changes
Other Study ID Numbers: N012009
Study First Received: June 29, 2009
Results First Received: April 15, 2014
Last Updated: May 14, 2014
Health Authority: United States: Food and Drug Administration