Safety and Efficacy Study of Healos as a Bone Replacement to Treat Degenerative Disc Disease

This study has been completed.
Sponsor:
Collaborator:
DePuy Spine
Information provided by:
Advanced Technologies and Regenerative Medicine, LLC (ATRM)
ClinicalTrials.gov Identifier:
NCT00316121
First received: April 18, 2006
Last updated: February 8, 2011
Last verified: February 2011
Results First Received: January 19, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Degenerative Disc Disease
Interventions: Device: HEALOS and Leopard Cage
Device: Leopard Cage and Autograft

  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 3Apr06 to 31Dec07. Subjects were seen at medical clinics/hospitals, usually by their regular doctor and not found through ads. Subjects were asked to enroll if they were having back surgery for back pain. Enrollment was stopped for administrative reasons at 138 subjects; the per protocol plan was at least 350 subjects.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
220 subjects were screened and 82 were excluded (59 did not meet criteria and 23 refused participation).Use of non-steroidal anti-inflammatory medications or cyclooxygenase-II (COX-2) inhibitors (a non-steroidal anti-inflammatory drug that directly targets COX-2, an enzyme responsible for inflammation and pain) at time of surgery were exclusionary.

Reporting Groups
  Description
HEALOS

HEALOS is a synthetic bone graft material made of collagen (a fibrous protein) and hydroxyapatite (a natural mineral structure). The collagen is a bovine derivative (obtained from cows). HEALOS is similar to what is found in natural bone and has the clearance of the U.S. Food and Drug Administration for use in filling bony voids or gaps of the skeletal system. It is combined with bone marrow (a vascular or vessel-like tissue found in the cavity of bone) to form new bone. HEALOS with bone marrow aspirate is currently available for use in a procedure where rods and screws are placed in the back with graft material to fuse the vertebrae.

The Leopard cage is a spinal implant made of a material called carbon fiber. HEALOS, when used with the Leopard Cage is an investigational device. An investigational device is one that is being tested and has not yet received approval from the Food and Drug Administration for the use in which it is being tested.

Control Autograft is bone taken from the subject’s own hip and placed in and around the spinal implant and spinal instrumentation. Local bone (bone from the area of surgery and placed in the fusion site) may be used in combination with autograft.

Participant Flow:   Overall Study
    HEALOS     Control  
STARTED     92     46  
COMPLETED     70     37  
NOT COMPLETED     22     9  
Death                 1                 0  
Lost to Follow-up                 14                 8  
Withdrawal by Subject                 2                 0  
Reason is missing                 1                 0  
Subject relocated                 1                 1  
Subject refused to return                 1                 0  
Subject no show for visit x 3                 1                 0  
Subject did not have 24 month visit                 1                 0  



  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
HEALOS

HEALOS is a synthetic bone graft material made of collagen (a fibrous protein) and hydroxyapatite (a natural mineral structure). The collagen is a bovine derivative (obtained from cows). HEALOS is similar to what is found in natural bone and has the clearance of the U.S. Food and Drug Administration for use in filling bony voids or gaps of the skeletal system. It is combined with bone marrow (a vascular or vessel-like tissue found in the cavity of bone) to form new bone. HEALOS with bone marrow aspirate is currently available for use in a procedure where rods and screws are placed in the back with graft material to fuse the vertebrae.

The Leopard cage is a spinal implant made of a material called carbon fiber. HEALOS, when used with the Leopard Cage is an investigational device. An investigational device is one that is being tested and has not yet received approval from the Food and Drug Administration for the use in which it is being tested.

Control Autograft is bone taken from the subject’s own hip and placed in and around the spinal implant and spinal instrumentation. Local bone (bone from the area of surgery and placed in the fusion site) may be used in combination with autograft.
Total Total of all reporting groups

Baseline Measures
    HEALOS     Control     Total  
Number of Participants  
[units: participants]
  92     46     138  
Age [1]
[units: Years]
Mean ( Full Range )
  47.4  
  ( 21 to 68 )  
  49.5  
  ( 22 to 70 )  
  48.45  
  ( 21 to 70 )  
Gender  
[units: participants]
     
Female     57     27     84  
Male     35     19     54  
[1] Between 18-70 years old



  Outcome Measures

1.  Primary:   Subject Success (Success is Defined Only if All of These Criteria Are Fulfilled)   [ Time Frame: 24 months ]


  Serious Adverse Events


  Other Adverse Events


  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.


Limitations and Caveats
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
Stringent criteria for endpoint.Minimum sample size not reached; no hypothesis testing.High portion of current/prior smokers in both groups may impact fusion success.Product usage was appropriate and not low.This study is not on label for HEALOS.  


Results Point of Contact:  
Name/Title: Manny Lazaro, Director, Clinical Affairs
Organization: Advanced Technologies and Regenerative Medicine, LLC
phone: 508-828-2741
e-mail: mlazaro@its.jnj.com


No publications provided


Responsible Party: Manny Lazaro, MS, Advanced Technologies and Regenerative Medicine, LLC
ClinicalTrials.gov Identifier: NCT00316121     History of Changes
Other Study ID Numbers: 05-HEALOS-01
Study First Received: April 18, 2006
Results First Received: January 19, 2011
Last Updated: February 8, 2011
Health Authority: United States: Food and Drug Administration