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A Prospective Study to Evaluate the Effectiveness of a Haemostatic Agent in Primary Unilateral Total Hip Arthroplasty

This study has been completed.
Sponsor:
Collaborators:
Orthovita d/b/a Stryker
Stryker Instruments
Information provided by (Responsible Party):
Wael Barsoum, The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT01285024
First received: January 26, 2011
Last updated: March 17, 2016
Last verified: March 2016
Results First Received: February 19, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Arthritis
Intervention: Device: Vitagel

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Control No Vitagel used during total hip arthroplasty
Vitagel

Vitagel applied just prior to closure during total hip arthroplasty

Vitagel: Two 4.5mL Vitagel Surgical Hemostat Kits, used just prior to closing the capsule.


Participant Flow:   Overall Study
    Control   Vitagel
STARTED   49   60 
COMPLETED   49   60 
NOT COMPLETED   0   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.
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Reporting Groups
  Description
Control No Vitagel used during total hip arthroplasty
Vitagel

Vitagel applied just prior to closure during total hip arthroplasty

Vitagel: Two 4.5mL Vitagel Surgical Hemostat Kits, used just prior to closing the capsule.

Total Total of all reporting groups

Baseline Measures
   Control   Vitagel   Total 
Overall Participants Analyzed 
[Units: Participants]
 49   60   109 
Age 
[Units: Years]
Mean (Standard Deviation)
 57.9  (9.4)   58.2  (11.8)   58.0  (10.7) 
Gender 
[Units: Participants]
     
Female   31   33   64 
Male   18   27   45 
BMI 
[Units: Kg/m^2]
Mean (Standard Deviation)
 30.1  (6.7)   32.6  (7.0)   31.5  (7.0) 


  Outcome Measures
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1.  Primary:   Transfusion Requirement   [ Time Frame: intraoperative - 1 week postoperative ]

2.  Secondary:   Total Hemoglobin Level Change   [ Time Frame: day of surgery - 1 week postoperative ]


  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
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  More Information
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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: President and CEO Cleveland Clinic Florida
Organization: Cleveland Clinic
phone: 216-444-7515
e-mail: barsouw@ccf.org



Responsible Party: Wael Barsoum, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01285024     History of Changes
Other Study ID Numbers: CCF 10-916
Study First Received: January 26, 2011
Results First Received: February 19, 2016
Last Updated: March 17, 2016
Health Authority: United States: Institutional Review Board