Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Trial Evaluating the Safety and Effectiveness of NUBAC™ Disc Arthroplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00931515
Recruitment Status : Completed
First Posted : July 2, 2009
Results First Posted : May 15, 2014
Last Update Posted : May 26, 2014
Sponsor:
Information provided by (Responsible Party):
Pioneer Surgical Technology, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Degenerative Disc Disease
Interventions Device: NuBac
Device: Prodisc-L
Enrollment 30
Recruitment Details 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 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.
Arm/Group Title NuBac ProDisc
Hide Arm/Group Description The NUBAC® disc arthroplasty system. The ProDisc® total disc replacement system.
Period Title: Overall Study
Started 15 15
Completed 13 10
Not Completed 2 5
Reason Not Completed
Lost to Follow-up             2             5
Arm/Group Title NuBac ProDisc Total
Hide Arm/Group Description The NUBAC® disc arthroplasty system. The ProDisc® total disc replacement system. Total of all reporting groups
Overall Number of Baseline Participants 15 15 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 30 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
14
  93.3%
15
 100.0%
29
  96.7%
>=65 years
1
   6.7%
0
   0.0%
1
   3.3%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants 15 participants 30 participants
44.0  (11.2) 40.1  (11.2) 42.05  (11.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 30 participants
Female
10
  66.7%
5
  33.3%
15
  50.0%
Male
5
  33.3%
10
  66.7%
15
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 15 participants 15 participants 30 participants
15 15 30
1.Primary Outcome
Title Participants With Improved Patient Function
Hide Description

The comparison of results was based on the proportion of participants with improved outcomes.

The primary efficacy variable was treatment success based on the following criteria:

  1. Oswestry Disability Index score improved by at least 15 points
  2. Device success
  3. Neurological success
  4. Absence of major complications
  5. Absence of fusion at the index level A patient was considered a success upon meeting all five criteria. Failure to meet any of these criteria resulted in classification as a treatment failure.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title NuBac ProDisc
Hide Arm/Group Description:
The NUBAC® disc arthroplasty system.
The ProDisc® device total disc replacement system.
Overall Number of Participants Analyzed 13 10
Measure Type: Number
Unit of Measure: participants
7 6
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection NuBac, ProDisc
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Time Frame 2 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title NuBac ProDisc
Hide Arm/Group Description The NUBAC® disc arthroplasty system. The ProDisc® device total disc replacement system.
All-Cause Mortality
NuBac ProDisc
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
NuBac ProDisc
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/15 (20.00%)      0/15 (0.00%)    
Surgical and medical procedures     
Device expulsion *  3/15 (20.00%)  3 0/15 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
NuBac ProDisc
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   11/15 (73.33%)      14/15 (93.33%)    
Gastrointestinal disorders     
Gastrointestinal complication *  1/15 (6.67%)  1 2/15 (13.33%)  2
Abdominal Pain *  1/15 (6.67%)  1 0/15 (0.00%)  0
General disorders     
Headache *  1/15 (6.67%)  1 0/15 (0.00%)  0
Alopecia *  1/15 (6.67%)  1 0/15 (0.00%)  0
Falling *  0/15 (0.00%)  0 1/15 (6.67%)  1
Musculoskeletal and connective tissue disorders     
Leg Pain *  1/15 (6.67%)  1 4/15 (26.67%)  4
Knee Pain *  1/15 (6.67%)  1 0/15 (0.00%)  0
Neck Pain *  1/15 (6.67%)  1 0/15 (0.00%)  0
Nervous system disorders     
Radiculitis *  0/15 (0.00%)  0 1/15 (6.67%)  1
Back Pain *  5/15 (33.33%)  5 9/15 (60.00%)  9
Hip/Buttock pain *  1/15 (6.67%)  1 3/15 (20.00%)  3
Leg paresthesia *  1/15 (6.67%)  1 0/15 (0.00%)  0
Psychiatric disorders     
Psychiatric *  0/15 (0.00%)  0 1/15 (6.67%)  1
Reproductive system and breast disorders     
Pregnancy *  1/15 (6.67%)  1 0/15 (0.00%)  0
Skin and subcutaneous tissue disorders     
Neck Cyst *  1/15 (6.67%)  1 0/15 (0.00%)  0
Surgical and medical procedures     
Implant migration *  2/15 (13.33%)  2 0/15 (0.00%)  0
Surgical site reaction *  0/15 (0.00%)  0 1/15 (6.67%)  1
Adjacent level complication *  2/15 (13.33%)  2 4/15 (26.67%)  4
Surgical treatment *  0/15 (0.00%)  0 1/15 (6.67%)  1
Shoulder Surgery *  1/15 (6.67%)  1 0/15 (0.00%)  0
Hand Surgery *  1/15 (6.67%)  1 1/15 (6.67%)  1
*
Indicates events were collected by non-systematic assessment
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.
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.
Research parties agree not to make any publications of results until notified in writing by Sponsor that study is complete and results published in peer-reviewed journal; however if not published within 18 months, Research parties may pursue publication of individual results. Research parties must submit communication to Sponsor for review/approval at least 30 days prior to submission. Sponsor can require the modification of the manuscript or delay of publication.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Director of Regulatory and Clinical Affairs
Organization: Pioneer Surgical Technology
Phone: 906-225-5602
EMail: emilydowns@pioneersurgical.com
Layout table for additonal information
Responsible Party: Pioneer Surgical Technology, Inc.
ClinicalTrials.gov Identifier: NCT00931515    
Other Study ID Numbers: N012009
First Submitted: June 29, 2009
First Posted: July 2, 2009
Results First Submitted: April 15, 2014
Results First Posted: May 15, 2014
Last Update Posted: May 26, 2014