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Prospective Evaluation of Vitagel for Reduction in Blood Loss and Pain Following Unilateral Total Knee Arthroplasty

This study has been completed.
Sponsor:
Collaborator:
Orthovita
Information provided by (Responsible Party):
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT01027286
First received: December 3, 2009
Last updated: October 30, 2012
Last verified: October 2012
History of Changes
Results First Received: August 30, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, 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
Vitagel Vitagel [Orthovita Inc., Malvern, PA], a collagen/thrombin and autologous platelet hemostatic agent, is applied just prior to surgical closure during primary total knee arthroplasty
Control No Vitagel used during primary total knee arthroplasty

Participant Flow:   Overall Study
    Vitagel     Control  
STARTED     50     50  
Preoperative     50     50  
Day of Surgery     50     50  
4 Week Postoperative     49     50  
12 Week Postoperative     49     49  
COMPLETED     49     49  
NOT COMPLETED     1     1  
Unable to Obtain Required Blood Volume                 1                 0  
Lost to Follow-up                 0                 1  



  Baseline Characteristics
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Reporting Groups
  Description
Vitagel Vitagel [Orthovita Inc., Malvern, PA], a collagen/thrombin and autologous platelet hemostatic agent, is applied just prior to surgical closure during primary total knee arthroplasty
Control No Vitagel used during primary total knee arthroplasty
Total Total of all reporting groups

Baseline Measures
    Vitagel     Control     Total  
Number of Participants  
[units: participants]
 		  50     50     100  
Age  
[units: years]
Mean ± Standard Deviation 		  66.3  ± 8.2     62.4  ± 8.8     64.0  ± 8.7  
Gender  
[units: participants]
 		     
Female     28     29     57  
Male     22     21     43  



  Outcome Measures
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1.  Primary:   Number of Patients Managed With Blood Transfusion   [ Time Frame: daily during hospital stay (an expected average of 4 days) ]
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2.  Secondary:   Total Calculated Hospital Blood Loss   [ Time Frame: daily during hospital stay (an expected average of 4 days) ]
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3.  Secondary:   Preoperative & Postoperative Hemoglobin Values   [ Time Frame: within 30 days before surgery (preop), daily during hospital stay (an expected average of 4 days) ]
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4.  Secondary:   Daily Narcotic Usage (Morphine-equivalent mg)   [ Time Frame: daily during hospital stay (an expected average of 4 days) ]
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5.  Secondary:   Length of Stay   [ Time Frame: day of hospital discharge ]
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6.  Secondary:   Pain Score Scale   [ Time Frame: within 30 days before surgery (preop), 4 weeks after surgery, 12 weeks after surgery ]
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7.  Secondary:   Knee Injury and Osteoarthritis Outcome Score (KOOS)   [ Time Frame: within 30 days before surgery (preop), 4 weeks after surgery, 12 weeks after surgery ]
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  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


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
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Results Point of Contact:  
Name/Title: Wael K Barsoum, MD
Organization: The Cleveland Clinic
phone: 216-444-7515
e-mail: barsouw@ccf.org


Publications of Results:


Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01027286     History of Changes
Other Study ID Numbers: 09-548
Study First Received: December 3, 2009
Results First Received: August 30, 2012
Last Updated: October 30, 2012
Health Authority: United States: Institutional Review Board