Preoperative Alignment of Total Knee Replacement

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. Identifier: NCT01242085
Recruitment Status : Completed
First Posted : November 16, 2010
Results First Posted : May 8, 2013
Last Update Posted : May 14, 2013
DePuy Orthopaedics
Information provided by (Responsible Party):
steven woolson, VA Palo Alto Health Care System

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition: Knee Arthritis
Interventions: Procedure: trumatch group
Procedure: control group

  Participant Flow

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
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

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

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 
Overall Participants Analyzed 
[Units: Participants]
 33   30   1   64 
[Units: Participants]
<=18 years   0   0   0   0 
Between 18 and 65 years   20   19   0   39 
>=65 years   13   11   1   25 
[Units: Years]
Mean (Standard Deviation)
 65.1  (8.3)   67.3  (7.7)   81  (0)   66.1  (7.9) 
[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

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

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

  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
none except small sample sizes

  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: Steven T Woolson, MD
Organization: VA Palo Alto HCS
phone: 650-493-5000 ext 66101

Responsible Party: steven woolson, VA Palo Alto Health Care System Identifier: NCT01242085     History of Changes
Other Study ID Numbers: 04061991
First Submitted: November 15, 2010
First Posted: November 16, 2010
Results First Submitted: February 19, 2013
Results First Posted: May 8, 2013
Last Update Posted: May 14, 2013