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A Retrospective Study of the iTotal CR Knee Replacement System

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ClinicalTrials.gov Identifier: NCT01564654
Recruitment Status : Completed
First Posted : March 28, 2012
Results First Posted : January 20, 2021
Last Update Posted : January 20, 2021
Sponsor:
Information provided by (Responsible Party):
ConforMIS, Inc.

Study Type Observational
Study Design Observational Model: Case-Only;   Time Perspective: Retrospective
Condition Osteoarthritis
Intervention Device: iTotal KRS
Enrollment 89
Recruitment Details  
Pre-assignment Details  
Arm/Group Title iTotal KRS
Hide Arm/Group Description iTotal KRS: Total Knee Replacement System
Period Title: Overall Study
Started 89 [1]
Completed 89 [1]
Not Completed 0
[1]
106 knees (bilateral)
Arm/Group Title iTotal KRS
Hide Arm/Group Description iTotal KRS: Total Knee Replacement System
Overall Number of Baseline Participants 89
Hide Baseline Analysis Population Description
106 knees (bilateral)
Age, Customized  
Mean (Full Range)
Unit of measure:  Years
Mean age at surgery Number Analyzed 89 participants
68
(42 to 87)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 89 participants
Female
53
  59.6%
Male
36
  40.4%
1.Primary Outcome
Title Knee Function
Hide Description Range of Motion
Time Frame Average of 7 months post-operative
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title iTotal KRS
Hide Arm/Group Description:
iTotal KRS: Total Knee Replacement System
Overall Number of Participants Analyzed 89
Overall Number of Units Analyzed
Type of Units Analyzed: Knees
106
Mean (Full Range)
Unit of Measure: degrees
113
(65 to 140)
2.Secondary Outcome
Title Revision Rate
Hide Description Number of knees that required a reoperation to remove/replace/add implant components
Time Frame Average of 7 months
Hide Outcome Measure Data
Hide Analysis Population Description
bilaterals were included
Arm/Group Title iTotal KRS
Hide Arm/Group Description:
iTotal KRS: Total Knee Replacement System
Overall Number of Participants Analyzed 89
Overall Number of Units Analyzed
Type of Units Analyzed: Knees
106
Count of Units
Unit of Measure: Knees
1
   0.9%
3.Secondary Outcome
Title Number of Transfusions
Hide Description Number of knees that required a blood transfusion during the initial hospital stay post-operative
Time Frame Initial hospital stay
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title iTotal KRS
Hide Arm/Group Description:
iTotal KRS: Total Knee Replacement System
Overall Number of Participants Analyzed 89
Overall Number of Units Analyzed
Type of Units Analyzed: Knees
106
Measure Type: Number
Unit of Measure: number of knees requiring transfusion
0
4.Secondary Outcome
Title Manipulations Under Anesthesia
Hide Description Number of knees that required a subsequent procedure to restore knee range of motion
Time Frame Up to 7 months post-operative
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title iTotal KRS
Hide Arm/Group Description:
iTotal KRS: Total Knee Replacement System
Overall Number of Participants Analyzed 89
Overall Number of Units Analyzed
Type of Units Analyzed: Knees
106
Count of Units
Unit of Measure: Knees
4
   3.8%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title iTotal KRS
Hide Arm/Group Description iTotal KRS: Total Knee Replacement System
All-Cause Mortality
iTotal KRS
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
iTotal KRS
Affected / at Risk (%) # Events
Total   5/89 (5.62%)    
Surgical and medical procedures   
Manipulations  4/89 (4.49%)  4
Revision/Poly Swap [1]  1/89 (1.12%)  1
[1]
Thicker insert implanted at 11 months post-op
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
iTotal KRS
Affected / at Risk (%) # Events
Total   0/89 (0.00%)    
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Marc Quartulli, VP Clinical Affairs
Organization: ConforMIS
Phone: 781-345-9191
EMail: marc.quartulli@conformis.com
Layout table for additonal information
Responsible Party: ConforMIS, Inc.
ClinicalTrials.gov Identifier: NCT01564654    
Other Study ID Numbers: CCP 11-002
First Submitted: March 26, 2012
First Posted: March 28, 2012
Results First Submitted: July 13, 2017
Results First Posted: January 20, 2021
Last Update Posted: January 20, 2021