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Preoperative Alignment of Total Knee Replacement

This study has been completed.
Sponsor:
Collaborator:
DePuy Orthopaedics
Information provided by (Responsible Party):
steven woolson, VA Palo Alto Health Care System
ClinicalTrials.gov Identifier:
NCT01242085
First received: November 15, 2010
Last updated: May 9, 2013
Last verified: May 2013
History of Changes
Results First Received: February 19, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Treatment
Condition: Knee Arthritis
Interventions: Procedure: trumatch group
Procedure: control group

  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
Participants were recruited from 6-2010 thru 6-2011 at the VA Palo Alto HCS

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
1 participant was excluded because withdrew prior to assignment

Reporting Groups
  Description
Trumatch Group trumatch group will have customized knee instruments : CT based customized knee instruments
Control Group control group will have standard instrumentation of their knee replacement
Both Interventions one participant had both interventions - one for each knee

Participant Flow:   Overall Study
    Trumatch Group     Control Group     Both Interventions  
STARTED     30     33     1  
COMPLETED     22 [1]   26 [2]   1  
NOT COMPLETED     8     7     0  
Withdrawal by Subject                 4                 2                 0  
medically unable to have surgery                 4                 5                 0  
[1] 8 patients did not undergo intervention since 4 had medical problems and 4 withdrew
[2] 7 patients did not receive allocated intervention since 5 had medical problems and 2 withdrew



  Baseline Characteristics
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Reporting Groups
  Description
Control

control group will have standard instrumentation of their knee replacement: standard instrumentation for knee replacement

study group will have customized knee instruments : CT based customized knee instruments
Trumatch Group patients randomized to study instrumentation
Both Interventions one participant had bilateral knee replacement with one control knee and one trumatch knee
Total Total of all reporting groups

Baseline Measures
    Control     Trumatch Group     Both Interventions     Total  
Number of Participants  
[units: participants]
 		  33     30     1     64  
Age  
[units: participants]
 		       
<=18 years     0     0     0     0  
Between 18 and 65 years     20     19     0     39  
>=65 years     13     11     1     25  
Age  
[units: years]
Mean ± Standard Deviation 		  65.1  ± 8.3     67.3  ± 7.7     81  ± 0     66.1  ± 7.9  
Gender  
[units: participants]
 		       
Female     0     0     0     0  
Male     33     30     1     64  
Region of Enrollment  
[units: participants]
 		       
United States     33     30     1     64  
knee replacement participant  
[units: participants]
 		  33     30     1     64  



  Outcome Measures
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1.  Primary:   Alignment of Knee - Measured Mechanical Axis From CT Data   [ Time Frame: postoperatively - CT done within 1 week of surgery ]
  Show Outcome Measure 1

2.  Secondary:   Surgical Time   [ Time Frame: intraoperative surgical time ]
  Show Outcome Measure 2


  Serious Adverse Events
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  Other Adverse Events
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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.


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
none except small sample sizes  


Results Point of Contact:  
Name/Title: Steven T Woolson, MD
Organization: VA Palo Alto HCS
phone: 650-493-5000 ext 66101
e-mail: steven.woolson@va.gov


No publications provided


Responsible Party: steven woolson, VA Palo Alto Health Care System
ClinicalTrials.gov Identifier: NCT01242085     History of Changes
Other Study ID Numbers: 04061991
Study First Received: November 15, 2010
Results First Received: February 19, 2013
Last Updated: May 9, 2013
Health Authority: United States: Federal Government