Prospective, Multi-Center Clinical Outcomes Study Evaluating the chronOS Strip Combined With Bone Marrow Aspirate

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Synthes USA HQ, Inc.
ClinicalTrials.gov Identifier:
NCT00943384
First received: July 21, 2009
Last updated: November 18, 2014
Last verified: November 2014
Results First Received: October 21, 2014  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Degeneration of Lumbar Intervertebral Disc
Intervention: Device: chronOS Strip

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
chronOS Strip Patients with DDD (with or without stenosis) were treated at one or two contiguous levels between L1 and S1 (inclusive) with interbody fusion and a posterolateral pedicle screw system. The study device (chronOS Strip) was applied to the posterolateral gutters combined with bone marrow aspirate and local bone.

Participant Flow:   Overall Study
    chronOS Strip  
STARTED     104 [1]
Treated     81 [2]
Treated on Protocol     76 [3]
COMPLETED     55 [4]
NOT COMPLETED     49  
Dispositioned prior to treatment                 23  
Treated off protocol-protocol violation                 5  
Lost to Follow-up                 16  
Withdrawal by Subject                 5  
[1] 104 subjects consented and underwent additional screening to determine eligibility to participate
[2] 81 subjects were eligible and willing to participate in the study and were treated
[3] 5 subjects were treated off protocol due to intraoperative decisions made by the surgeon
[4] evaluated at the Month 24 visit with complete or partial data



  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.
Number of subjects treated per protocol

Reporting Groups
  Description
chronOS Strip Patients with DDD (with or without stenosis) were treated at one or two contiguous levels between L1 and S1 (inclusive) with interbody fusion and a posterolateral pedicle screw system. The study device (chronOS Strip) was applied to the posterolateral gutters combined with bone marrow aspirate and local bone.

Baseline Measures
    chronOS Strip  
Number of Participants  
[units: participants]
  76  
Age  
[units: years]
Mean (Standard Deviation)
  50.1  (10.37)  
Gender  
[units: participants]
 
Female     40  
Male     36  
Level(s) treated [1]
[units: participants]
 
One-level, L2-3     1  
One-level, L3-4     1  
One level, L4-5     22  
One-level, L5-S1     18  
Two-level, L3-5     8  
Two-level, L4-S1     26  
[1] Subjects were treated at one or two contiguous levels from L2 through S1



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Posterolateral Fusion Success   [ Time Frame: Month 24 ]

2.  Secondary:   Oswestry Disability Index (ODI)   [ Time Frame: Month 24 ]

3.  Secondary:   Percent Change in Oswestry Disability Index (ODI)   [ Time Frame: Month 24 ]

4.  Secondary:   Back Pain on Visual Analog Scale   [ Time Frame: Month 24 ]

5.  Secondary:   Percent Change in Back Pain on Visual Analog Scale   [ Time Frame: Month 24 ]

6.  Secondary:   Leg Pain on Visual Analog Scale   [ Time Frame: Month 24 ]

7.  Secondary:   Percent Change in Leg Pain on Visual Analog Scale   [ Time Frame: Month 24 ]

8.  Secondary:   Short Form 12 (SF-12v2) Physical Component Summary (PCS)   [ Time Frame: Month 24 ]

9.  Secondary:   Percent Change in Short Form 12 (SF-12v2) Physical Component Summary (PCS)   [ Time Frame: Month 24 ]

10.  Secondary:   Short Form 12 (SF-12v2) Mental Component Summary (MCS)   [ Time Frame: Month 24 ]

11.  Secondary:   Percent Change in Short Form 12 (SF-12v2) Mental Component Summary (MCS)   [ Time Frame: Month 24 ]


  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
Limitations included lack of control arm, no hypothesis for primary endpoint, & qualitative sample size estimate. chronOS Strip was used according to its FDA-cleared labeling; other usage was outside the study scope and was not evaluated clinically.


  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 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Allyson Morris, PhD, CCRP, Staff Clinical Research Scientist
Organization: DePuy Synthes Clinical Affairs
phone: 610-719-5298
e-mail: morris.allyson@synthes.com


No publications provided


Responsible Party: Synthes USA HQ, Inc.
ClinicalTrials.gov Identifier: NCT00943384     History of Changes
Other Study ID Numbers: chronOS-050709
Study First Received: July 21, 2009
Results First Received: October 21, 2014
Last Updated: November 18, 2014
Health Authority: United States: Institutional Review Board