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History of Changes for Study: NCT01861028
Study Comparing Fit of the iTotal Versus Standard Total Knee Implants
Latest version (submitted December 2, 2020) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 May 21, 2013 None (earliest Version on record)
2 January 23, 2014 Study Status and Study Identification
3 August 22, 2014 Study Status
4 April 9, 2015 Study Status, Eligibility, Groups and Interventions and Study Description
5 June 18, 2015 Study Status and Study Identification
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Results Submission Events
6 December 2, 2020 Recruitment Status, Study Status, Outcome Measures, Contacts/Locations, Study Design, Results and IPDSharing
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Study NCT01861028
Submitted Date:  May 21, 2013 (v1)

Open or close this module Study Identification
Unique Protocol ID: CCP 12-002
Brief Title: Study Comparing Fit of the iTotal Versus Standard Total Knee Implants
Official Title:
Secondary IDs:
Open or close this module Study Status
Record Verification: May 2013
Overall Status: Recruiting
Study Start: February 2013
Primary Completion: June 2015 [Anticipated]
Study Completion:
First Submitted: March 26, 2013
First Submitted that
Met QC Criteria:
May 21, 2013
First Posted: May 23, 2013 [Estimate]
Last Update Submitted that
Met QC Criteria:
May 21, 2013
Last Update Posted: May 23, 2013 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: ConforMIS, Inc.
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
Brief Summary: This study compares intraoperative fit of the patient-specific iTotal knee replacement to other standard knee replacement implants
Detailed Description:
Open or close this module Conditions
Conditions: Osteoarthritis
Keywords: total knee replacement
total knee arthroplasty
patient-specific
Open or close this module Study Design
Study Type: Observational
Observational Study Model: Cohort
Time Perspective: Prospective
Biospecimen Retention:
Biospecimen Description:
Enrollment: 75 [Anticipated]
Number of Groups/Cohorts 0
Open or close this module Groups and Interventions
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Tibial and Femoral Implant Fit
[ Time Frame: Intraoperatively ]

Fit will be measured in 5 quadrants on the tibia using a ruler to measure the distance between the implant and the edge of the tibia.

Fit will be measured in the Medial-lateral dimension on both condyles on the femur in 5 or 6 different zones, depending on whether the femoral implant has 5 or 6 facets. Measurements will also be done in mm.

Secondary Outcome Measures:
1. Knee Society Score
[ Time Frame: 1 Year ]

Open or close this module Eligibility
Study Population: Patients receiving either a standard total knee implant or an iTotal patient-specific total knee implant
Sampling Method: Non-Probability Sample
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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
Open or close this module Contacts/Locations
Study Officials: Gregory Martin, MD
Principal Investigator
JFK Medical Center
Locations: United States, Florida
JFK Medical Center
[Recruiting]
Atlantis, Florida, United States, 33462
Contact:Contact: Jamie Kosik 561-548-1414 Jamie.Kosik@hcahealthcare.com
Contact:Principal Investigator: Gregory Martin, MD
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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