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Alignment Comparison Between TruMatch™ Personalized Solutions and Conventional Total Knee Replacement Instrumentation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
DePuy Orthopaedics
ClinicalTrials.gov Identifier:
NCT01108237
First received: April 1, 2010
Last updated: March 4, 2013
Last verified: March 2013
History of Changes
Results First Received: March 27, 2012  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Osteoarthritis, Knee
Interventions: Other: TruMatch™ Personalized Solutions
Device: Total Knee Arthroplasty with Conventional Instrumentation.

  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
The TruMatch (patient-specific instruments) arm of this study was a prospective, multi-center, non-randomized, clinical investigation conducted at 4 sites. The other arm of this study (conventional instruments) included 84 historical control subjects.

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
TruMatch™ Personalized Solutions Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using TruMatch™ Personalized Solutions
Total Knee Arthroplasty With Conventional Instrumentation Total Knee Arthroplasty (PFC Sigma System) implanted using conventional instruments, not TruMatch™ instrumentation.

Participant Flow:   Overall Study
    TruMatch™ Personalized Solutions     Total Knee Arthroplasty With Conventional Instrumentation  
STARTED     73 [1]   101  
COMPLETED     64 [2]   84  
NOT COMPLETED     9     17  
No alignment data                 2                 17  
Did not meet criteria for analysis                 7                 0  
[1] 78 subjects were consented with intent to treat, however, 73 had surgery.
[2] 66 subjects underwent surgery per the protocol, however, only 64 met the primary end point.



  Baseline Characteristics
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  Outcome Measures

1.  Primary:   Mechanical Axis Alignment(Absolute Value Measured in Degrees)Using 51 Inch Long Leg Films   [ Time Frame: 12 weeks postoperatively (when subject has reached full knee extension) ]
  Show Outcome Measure 1


  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 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI 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
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Results Point of Contact:  
Name/Title: Sam Himden
Organization: DePuy Orthopaedics, Inc.
phone: 574-372-7231
e-mail: SHimden@its.jnj.com


No publications provided


Responsible Party: DePuy Orthopaedics
ClinicalTrials.gov Identifier: NCT01108237     History of Changes
Other Study ID Numbers: 08003
Study First Received: April 1, 2010
Results First Received: March 27, 2012
Last Updated: March 4, 2013
Health Authority: United States: Institutional Review Board