- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02186587
iTotal Pilot Study of ConforMIS Custom Total Knee Implant
CT-navigated, Patient-specific Custom Total Knee Replacement Versus Standard Total Knee Replacement: Comparison With a Marker-less Gait Analysis System and Validated Outcome Scores
To compare the outcomes of patients receiving the ConforMIS custom total knee implant to the outcomes of patients who receiving an off-the-shelf total knee implant.
Hypothesis: Patient-specific, custom total knee implants manufactured from patient CT data, and implanted with CT-navigated custom instruments will show faster functional recovery, including gait and patient functional outcome scores, when compared to standard, off-the-shelf total knee components inserted with non-navigated instruments (the present standard of care in total knee surgery).
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Missouri
-
Columbia, Missouri, United States, 65212
- Missouri Orthopaedic Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- undergoing total knee arthroplasty
Exclusion Criteria:
- BMI >40
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: ConforMIS
Subjects who receive a ConforMIS custom total knee implant.
|
Total knee arthroplasty using ConforMIS custom total knee system with follow-up at 6 months
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Distance Measured During 6-minute Walk Test
Time Frame: 6 months
|
Subjects will walk for 6 minutes and the distance covered will be measured in feet.
|
6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sonny Bal, MD, Professor - PI
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 1206872
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Knee Arthroplasty, Total
-
Limacorporate S.p.aRecruitingTotal Knee Arthroplasty | Revision Total Knee ArthroplastyUnited Kingdom, Portugal, Slovakia
-
DePuy OrthopaedicsJohnson & Johnson Health and Wellness Solutions, Inc.TerminatedTotal Knee Arthroplasty; Total Hip ArthroplastyUnited States
-
DePuy OrthopaedicsJohnson & Johnson Health and Wellness Solutions, Inc.TerminatedTotal Knee Arthroplasty; Total Hip ArthroplastyUnited States
-
Northern Orthopaedic Division, DenmarkCompletedTotal Knee Arthroplasty | Total Hip ArthroplastyDenmark
-
Istanbul UniversityCompleted
-
Singapore General HospitalCompletedTotal Knee Arthroplasty | Total Knee ReplacementSingapore
-
Istanbul UniversityCompletedTotal Knee Arthroplasty | Total Knee ReplacementTurkey
-
Smith & Nephew, Inc.Completed
-
University of AlbertaCompletedArthroplasty, Replacement, Knee | Knee Arthroplasty, TotalCanada
-
University of North Carolina, Chapel HillNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)CompletedKnee Arthroplasty, Total | Knee Replacement, TotalUnited States
Clinical Trials on ConforMIS custom total knee
-
Restor3DCompletedOsteoarthritisUnited States, Germany
-
Restor3DCompletedOsteoarthritis,KneeUnited States
-
Restor3DTerminatedOsteoarthritis, KneeUnited States
-
Restor3DCompletedComplications; ArthroplastyUnited States
-
Tufts Medical CenterConforMIS, Inc.Terminated
-
Restor3DTerminatedOsteoarthritisUnited States
-
Austrian Workers Compensation Board StyriaRecruiting
-
Foundation for Southwest Orthopedic ResearchCompleted
-
Restor3DTerminatedOsteoarthritis, KneeUnited States
-
Zimmer BiometCompletedRheumatoid Arthritis | Knee Pain | Chronic Osteoarthritis | Avascular Necrosis of the Femoral Condyle | Moderate Varus, Valgus or Flexion DeformitiesUnited States