The 3DKnee™ System: A Post-Market Study

This study has been completed.
Sponsor:
Information provided by:
Encore Medical, L.P.
ClinicalTrials.gov Identifier:
NCT00764673
First received: September 30, 2008
Last updated: February 8, 2011
Last verified: February 2011
Results First Received: November 19, 2010  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Osteoarthritis
Rheumatoid Arthritis
Post Traumatic Arthritis
Varus Deformity
Avascular Necrosis
Intervention: Device: 3DKnee

  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
Primary 3DKnee Implant Subjects who require a knee implant that have not previously had a knee replacement in the operative knee.

Participant Flow:   Overall Study
    Primary 3DKnee Implant  
STARTED     71  
COMPLETED     59  
NOT COMPLETED     12  
Death                 1  
Lost to Follow-up                 3  
Withdrawal by Subject                 6  
Revision of Device                 2  



  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.
No text entered.

Reporting Groups
  Description
Primary 3DKnee Implant Subjects who require a knee implant that have not previously had a knee replacement in the operative knee.

Baseline Measures
    Primary 3DKnee Implant  
Number of Participants  
[units: participants]
  71  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     25  
>=65 years     46  
Age  
[units: years]
Mean ± Standard Deviation
  69  ± 8.7  
Gender  
[units: participants]
 
Female     49  
Male     22  
Region of Enrollment  
[units: participants]
 
United States     71  
Operated Knee [1]
[units: participants]
 
Right knee     36  
Left knee     35  
Primary Diagnosis [2]
[units: participants]
 
Osteoarthritis     69  
Varus deformity     1  
Post-traumatic arthritis     1  
[1] Affected knee which received the implant
[2] Physician diagnosis of indication for receiving a total knee implant.



  Outcome Measures
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1.  Primary:   Knee Society Score Evaluation   [ Time Frame: 2 year ]

2.  Primary:   Knee Society Function Score   [ Time Frame: 2-year ]

3.  Primary:   Number of Participants With >2mm Wide at the Bone/Cement Interface or a >3 Degree or >3 mm Migration (Shift) of the Component.   [ Time Frame: 2-year ]

4.  Primary:   Safety Assessment   [ Time Frame: 2-year ]

5.  Secondary:   Oxford Knee Score   [ Time Frame: 2-year ]


  Serious Adverse Events


  Other Adverse Events


  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
No text entered.  


Results Point of Contact:  
Name/Title: Manager of Clinical Affairs
Organization: DJO Surgical
phone: 512-832-9500 ext 6323
e-mail: jane.jacob@djosurgical.com


No publications provided


Responsible Party: Jane M. Jacob Ph.D., DJO Surgical
ClinicalTrials.gov Identifier: NCT00764673     History of Changes
Other Study ID Numbers: PS - 703
Study First Received: September 30, 2008
Results First Received: November 19, 2010
Last Updated: February 8, 2011
Health Authority: United States: Institutional Review Board