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Study Comparing Fit of the iTotal Versus Standard Total Knee Implants

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ClinicalTrials.gov Identifier: NCT01861028
Recruitment Status : Terminated (Not enough patient volume to continue the study.)
First Posted : May 23, 2013
Results First Posted : December 28, 2020
Last Update Posted : December 28, 2020
Sponsor:
Information provided by (Responsible Party):
ConforMIS, Inc.

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Osteoarthritis
Enrollment 44
Recruitment Details  
Pre-assignment Details  
Arm/Group Title iTotal CR TKR
Hide Arm/Group Description A series of 44 consecutive primary iTotal patients will be compared to assess the fit of the tibial tray intra-operatively. These patients will have a series of tibial templates from Standard TKR implant sets trialed on the operative knee. Each template will be optimally sized and positioned based on the surgeon's judgment. Implant fit data (overhang and underhang) on the tibia for all templates will be taken from intra-operative measurements
Period Title: Overall Study
Started 44
Completed 44
Not Completed 0
Arm/Group Title iTotal CR TKR
Hide Arm/Group Description A series of 44 consecutive primary iTotal patients will be compared to assess the fit of the tibial tray intra-operatively. These patients will have a series of tibial templates from Standard TKR implant sets trialed on the operative knee. Each template will be optimally sized and positioned based on the surgeon's judgment. Implant fit data (overhang and underhang) on the tibia for all templates will be taken from intra-operative measurements
Overall Number of Baseline Participants 44
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants
<=18 years
0
   0.0%
Between 18 and 65 years
12
  27.3%
>=65 years
32
  72.7%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 44 participants
70.48
(57 to 87)
Sex/Gender, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Women Number Analyzed 44 participants
17
  38.6%
1.Primary Outcome
Title Phase I: Number of Participants With a Customized Tibia Implant Displaying an Overhang of 3 mm or Greater
Hide Description Fit will be measured in 4 quadrants on the tibia using a ruler to measure the distance between the customized implant and the edge of the tibia.
Time Frame Intraoperatively, up to 120 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
44 consecutive primary iTotal patients - number of patients with overhang of 3mm or more
Arm/Group Title Phase I
Hide Arm/Group Description:
A series of 44 consecutive primary iTotal patients will be compared to assess the fit of the tibial tray intra-operatively. These patients will have a series of tibial templates from Standard TKR implant sets trialed on the operative knee. Each template will be optimally sized and positioned based on the surgeon's judgment. Implant fit data (overhang and underhang) on the tibia for all templates will be taken from intra-operative measurements
Overall Number of Participants Analyzed 44
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
2.Primary Outcome
Title Phase II: Number of Participants With an Off-the-Shelf Implant Displaying an Overhang of 3 mm or Greater
Hide Description Fit will be measured in 3 quadrants on the tibia using a ruler to measure the distance between the off-the-shelf design and the edge of the tibia.
Time Frame Intraoperatively, up to 120 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
44 consecutive primary iTotal patients - number of patients with overhang of 3mm or more
Arm/Group Title Enrolled Subjects
Hide Arm/Group Description:
A series of 44 consecutive primary iTotal patients will be compared to assess the fit of the tibial tray intra-operatively. These patients will have a series of tibial templates from Standard TKR implant sets trialed on the operative knee. Each template will be optimally sized and positioned based on the surgeon's judgment. Implant fit data (overhang and underhang) on the tibia for all templates will be taken from intra-operative measurements
Overall Number of Participants Analyzed 44
Measure Type: Count of Participants
Unit of Measure: Participants
8
  18.2%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Enrolled Subjects
Hide Arm/Group Description A series of 44 consecutive primary iTotal patients will be compared to assess the fit of the tibial tray intra-operatively. These patients will have a series of tibial templates from Standard TKR implant sets trialed on the operative knee. Each template will be optimally sized and positioned based on the surgeon's judgment. Implant fit data (overhang and underhang) on the tibia for all templates will be taken from intra-operative measurements
All-Cause Mortality
Enrolled Subjects
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Enrolled Subjects
Affected / at Risk (%)
Total   0/44 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Enrolled Subjects
Affected / at Risk (%)
Total   0/44 (0.00%) 
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
Layout table for Results Point of Contact information
Name/Title: Director of Clinical and Technical Research
Organization: Conformis
Phone: 781-345-9103
EMail: sumesh.zingde@conformis.com
Layout table for additonal information
Responsible Party: ConforMIS, Inc.
ClinicalTrials.gov Identifier: NCT01861028    
Other Study ID Numbers: 12-002
First Submitted: March 26, 2013
First Posted: May 23, 2013
Results First Submitted: July 16, 2019
Results First Posted: December 28, 2020
Last Update Posted: December 28, 2020