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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 Description
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Brief Summary:
This study compares intraoperative fit of the patient-specific iTotal knee replacement to other standard knee replacement implants

Condition or disease
Osteoarthritis

Detailed Description:

The study is designed as a single center, two arm analysis. The study will be completed in two phases, based on measurement type.

All additional data will be obtained from pre and post-operative subject surveys, operative and discharge records and radiographs.

Study Design
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Study Type : Observational
Actual Enrollment : 44 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study Comparing Fit of the iTotal Versus Standard Total Knee Implants
Study Start Date : February 2013
Actual Primary Completion Date : September 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
Phase I
A series of 50 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
Phase II
The Phase I (50 consecutive primary iTotal patients) will also have implant fit data assessed for the femur. After final implantation is complete measurement will be assessed and recorded. A series of 25 primary knees that are scheduled for Standard TKR implants will then undergo the same measurements of the femur.


Outcome Measures
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Primary Outcome Measures :
  1. Phase I: Number of Participants With a Customized Tibia Implant Displaying an Overhang of 3 mm or Greater [ Time Frame: Intraoperatively, up to 120 minutes ]
    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.

  2. Phase II: Number of Participants With an Off-the-Shelf Implant Displaying an Overhang of 3 mm or Greater [ Time Frame: Intraoperatively, up to 120 minutes ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients receiving either a standard total knee implant or an iTotal patient-specific total knee implant
Criteria

Inclusion Criteria:

  • Patients who are scheduled for a standard total knee replacement
  • Patient who are scheduled for patient-specific total knee replacement (iTotal)
  • Patient age > 18 years

Exclusion Criteria:

  • Patients who do not receive a total knee replacement
  • Unwilling or unable to comply with study requirements
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01861028


Locations
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United States, Florida
JFK Medical Center
Atlantis, Florida, United States, 33462
Sponsors and Collaborators
ConforMIS, Inc.
Investigators
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Principal Investigator: Gregory Martin, MD JFK Medical Center
More Information
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Responsible Party: ConforMIS, Inc.
ClinicalTrials.gov Identifier: NCT01861028    
Other Study ID Numbers: 12-002
First Posted: May 23, 2013    Key Record Dates
Results First Posted: December 28, 2020
Last Update Posted: December 28, 2020
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by ConforMIS, Inc.:
total knee replacement
total knee arthroplasty
patient-specific
Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases