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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 : Unknown
Verified June 2015 by ConforMIS, Inc..
Recruitment status was:  Recruiting
First Posted : May 23, 2013
Last Update Posted : June 19, 2015
Sponsor:
Information provided by (Responsible Party):
ConforMIS, Inc.

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 Type : Observational
Estimated Enrollment : 75 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
Estimated Primary Completion Date : September 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


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.



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 ]


Information from the National Library of Medicine

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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

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
United States, Florida
JFK Medical Center Recruiting
Atlantis, Florida, United States, 33462
Contact: Jamie Kosik    561-548-1414    Jamie.Kosik@hcahealthcare.com   
Principal Investigator: Gregory Martin, MD         
Sponsors and Collaborators
ConforMIS, Inc.
Investigators
Principal Investigator: Gregory Martin, MD JFK Medical Center

Responsible Party: ConforMIS, Inc.
ClinicalTrials.gov Identifier: NCT01861028     History of Changes
Other Study ID Numbers: 12-002
First Posted: May 23, 2013    Key Record Dates
Last Update Posted: June 19, 2015
Last Verified: June 2015

Keywords provided by ConforMIS, Inc.:
total knee replacement
total knee arthroplasty
patient-specific

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases