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Completed Not applicable Interventional Results available

iTotal Pilot Study of ConforMIS Custom Total Knee Implant

ClinicalTrials.gov ID: NCT02186587

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This page only displays public information reproduced from the official ClinicalTrials.gov record NCT02186587. It adds no medical advice, opinions, or eligibility judgments. The official record remains the source of truth for eligibility criteria, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Nov 14, 2026, 9:53 AM EST

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Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID
NCT02186587
Recruitment status
Completed
Study type
Interventional
Phase
Not applicable
Enrollment
28 participants

Conditions and interventions

Interventions

Device

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jun 2014 (Type not available)
Primary completion
Jun 2015 (Actual)
Completion
Apr 2016 (Actual)
Last update posted
May 23, 2023

2014 – 2016

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Missouri Orthopaedic Institute Columbia Missouri 65212 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02186587, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted May 23, 2023 · Synced Nov 14, 2026

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