ClinicalTrials.gov
ClinicalTrials.gov Menu

Study Performance of The Plexur P™ Bone Void Filler Device in Patients Undergoing Iliac Crest Harvesting Procedures

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: NCT00837473
Recruitment Status : Completed
First Posted : February 5, 2009
Results First Posted : April 30, 2018
Last Update Posted : April 30, 2018
Sponsor:
Information provided by (Responsible Party):
Medtronic Spinal and Biologics ( Osteotech, Inc )

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Iliac Crest Harvesting Procedure-Bone Void Filler
Intervention: Device: Plexur-P used as a Bone Void Filler in Iliac Crest Harvesting Procedures

  Participant Flow

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
Plexur-P Bone Void Filler

Single arm. Open Label.

Plexur-P used as a Bone Void Filler in Iliac Crest Harvesting Procedures: Plexur-P used as a Bone Void Filler in Iliac Crest Harvesting Procedures


Participant Flow:   Overall Study
    Plexur-P Bone Void Filler
STARTED   15 
COMPLETED   12 
NOT COMPLETED   3 
Lost to Follow-up                1 
Withdrawal by Subject                2 



  Baseline Characteristics

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
Plexur-P Bone Void Filler

Single arm. Open Label.

Plexur-P used as a Bone Void Filler in Iliac Crest Harvesting Procedures: Plexur-P used as a Bone Void Filler in Iliac Crest Harvesting Procedures


Baseline Measures
   Plexur-P Bone Void Filler 
Overall Participants Analyzed 
[Units: Participants]
 15 
Age 
[Units: Years]
Mean (Standard Deviation)
 56.13  (9.45) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      13  86.7% 
Male      2  13.3% 


  Outcome Measures

1.  Primary:   Number of Participants With Reconstitution of Bone Growth in the Iliac Crest Bone Void Determined by an Independent Radiologist   [ Time Frame: 6 wks, 3 mths, 6 mths 12 mths, and 24 mths ]

2.  Secondary:   General Health Status   [ Time Frame: Baseline, 6 wks, 3 mths, 6 mths, 12 mths, and 24 mths ]

3.  Secondary:   Oswestry Disability Index   [ Time Frame: Baseline, 6 wks, 3 mths, 6 mths, 12 mths, and 24 mths ]

4.  Secondary:   Pain Status Assessed by Visual Analog Scale (VAS)   [ Time Frame: Baseline, 6 wks, 3 mths, 6 mths, 12 mths, and 24 mths ]

5.  Secondary:   Surgical Related Outcome--locations of Iliac Crest Bone Harvest   [ Time Frame: During the time of operation, a range of 2.5-8.5 hrs ]

6.  Secondary:   Surgical outcome-the Amount of Cancellous Bone Harvested   [ Time Frame: During the time of operation, a range of 2.5-8.5 hrs ]

7.  Secondary:   Surgical Outcome--operative Time   [ Time Frame: The time of operation, a range of 2.5-8.5 hrs ]

8.  Secondary:   Surgical Outcome--blood Loss   [ Time Frame: During the time of operation, a range of 2.5-8.5 hrs ]

9.  Secondary:   Surgical Outcome--length of Hospital Stay   [ Time Frame: From admission to discharge, a range of 2 to 20 days ]

10.  Secondary:   Surgical Outcome- the Amount of Plexur™ P Product Utilized for Filling Void   [ Time Frame: During the time of operation, a range of 2.5-8.5 hrs ]


  Serious Adverse Events


  Other Adverse Events


  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
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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: Clinical Department
Organization: Medtronic Spine and Biologics
phone: 1800-876-3133 ext 6068
e-mail: msbkclinicalresearch@medtronic.com



Responsible Party: Medtronic Spinal and Biologics ( Osteotech, Inc )
ClinicalTrials.gov Identifier: NCT00837473     History of Changes
Other Study ID Numbers: Trial #3206
First Submitted: February 4, 2009
First Posted: February 5, 2009
Results First Submitted: March 13, 2018
Results First Posted: April 30, 2018
Last Update Posted: April 30, 2018