CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 28 enrolled
Drug / intervention
ConforMIS custom total kneedevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02186587
NCT02186587N/ACompleted
CompareCT.gov

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

University of Missouri-Columbia·interventional·Posted Jul 10, 2014·Updated May 23, 2023

In Brief

A clinical study evaluating ConforMIS custom total knee for Knee Arthroplasty, Total. Completed, enrolled 28 participants across 1 site.

Detailed Summary

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 Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsKnee Arthroplasty, Total
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedJul 10, 2014
Enrollment StartJun 1, 2014
Primary CompletionJun 1, 2015
Study CompletionApr 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 12.0 years ago

Interventions

ConforMIS custom total kneedevice

Total knee arthroplasty using ConforMIS custom total knee system with follow-up at 6 months