Comparison of Surgical Time and Efficiency of Total Knee Arthroplasty

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
DePuy Orthopaedics
ClinicalTrials.gov Identifier:
NCT01301950
First received: December 2, 2010
Last updated: August 26, 2014
Last verified: August 2014
Results First Received: June 25, 2014  
Study Type: Observational
Study Design: Observational Model: Case Control;   Time Perspective: Prospective
Condition: Osteoarthritis, Knee
Intervention: Other: Instrument

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Conventional Total Knee Replacement Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using conventional instruments
TruMatch® Personalized Solutions

Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (P.F.C. Sigma System) implanted using TruMatch® Personalized Solutions.

Instrument: TruMatch® Personalized Solutions is the brand name of DePuy Orthopaedics, Inc. custom patient instrumentation. TruMatch® is a pair of custom-made cutting blocks that allow distal femoral and proximal tibial cuts to be made according to a predefined surgical plan. The inner surface of the femoral block is manufactured to match the geometry of the patients' distal femur. The inner surface of the tibial block is manufactured to match the patient's proximal tibia. The geometric data is obtained from a CT scan and a preoperative plan approved by the surgeon.


Participant Flow:   Overall Study
    Conventional Total Knee Replacement     TruMatch® Personalized Solutions  
STARTED     15     15  
COMPLETED     15     14  
NOT COMPLETED     0     1  
Surgery was cancelled by patient                 0                 1  



  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.
All subjects who were consented prior to surgery were included in the analysis of baseline characteristics.

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

Instrument: TruMatch® Personalized Solutions is the brand name of DePuy Orthopaedics, Inc. custom patient instrumentation. TruMatch® is a pair of custom-made cutting blocks that allow distal femoral and proximal tibial cuts to be made according to a predefined surgical plan. The inner surface of the femoral block is manufactured to match the geometry of the patient's distal femur. The inner surface of the tibial block is manufactured to match the patient's proximal tibia. The geometric data is obtained from a CT scan and a preoperative plan approved by the surgeon

Conventional Total Knee Replacement Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using conventional instruments
Total Total of all reporting groups

Baseline Measures
    TruMatch® Personalized Solutions     Conventional Total Knee Replacement     Total  
Number of Participants  
[units: participants]
  15     15     30  
Age  
[units: years]
Mean ± Standard Deviation
  62.9  ± 12.9     62.7  ± 9.1     62.8  ± 10.9  
Gender  
[units: participants]
     
Female     6     11     17  
Male     9     4     13  
Region of Enrollment  
[units: participants]
     
United States     15     15     30  



  Outcome Measures
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1.  Primary:   Surgical Procedure Time to Compare Skin-to-Skin Time for Conventional Versus TruMatch® Primary Total Knee Replacements   [ Time Frame: Intraoperative ]

2.  Secondary:   Operating Room Setup - Operating Room Cleaned up From Previous Case to Surgical Draping Complete   [ Time Frame: Intraoperative ]

3.  Secondary:   Turnover Time (Time to Clean Operating Room After Surgery is Completed)   [ Time Frame: Intraoperative ]

4.  Secondary:   To Compare the Costs Associated With Conventional Versus TruMatch® Total Knee Arthroplasty Surgical Procedures   [ Time Frame: Intraoperative ]

5.  Secondary:   To Compare the Differences in Operating Room Efficiency as a Function of Institution Type and Geographical Location   [ Time Frame: Intraoperative ]


  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
A statistically powered sample size was not obtained; Two secondary objectives (compare costs & compare differences in OR efficiency as a function of institution type & geographic location) could not be assessed as originally intended by the protocol


  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.


Results Point of Contact:  
Name/Title: Sam Himden, Clinical Portfolio Leader
Organization: DePuy Synthes
phone: 574-372-7231
e-mail: shimden@its.jnj.com


No publications provided


Responsible Party: DePuy Orthopaedics
ClinicalTrials.gov Identifier: NCT01301950     History of Changes
Other Study ID Numbers: 08004
Study First Received: December 2, 2010
Results First Received: June 25, 2014
Last Updated: August 26, 2014
Health Authority: United States: Institutional Review Board