Trial Outcomes & Findings for iTotal Pilot Study of ConforMIS Custom Total Knee Implant (NCT NCT02186587)

Results Overview

Subjects will walk for 6 minutes and the distance covered will be measured in feet.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

28 participants

Primary outcome timeframe

6 months

Results posted on

2023-05-23

Participant milestones
Measure	ConforMIS Subjects in this arm will receive a ConforMIS custom total knee implant. ConforMIS custom total knee	Off-the-shelf Subjects in this arm will receive an off-the-shelf total knee implant. Off-the-shelf total knee implant
Overall Study STARTED	28	0
Overall Study COMPLETED	23	0
Overall Study NOT COMPLETED	5	0

Withdrawal data not reported

iTotal Pilot Study of ConforMIS Custom Total Knee Implant

Baseline characteristics by cohort
Measure	ConforMIS n=28 Participants Subjects in this arm will be having a ConforMIS custom total knee implant as part of standard of care. ConforMIS custom total knee	Off-the-shelf Subjects in this arm will receive an off-the-shelf total knee implant as part of standard of care. Off-the-shelf total knee implant	Total n=28 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	19 Participants n=5 Participants	—	19 Participants n=5 Participants
Age, Categorical >=65 years	9 Participants n=5 Participants	—	9 Participants n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	—	18 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	—	10 Participants n=5 Participants

Timeframe: 6 months

Subjects will walk for 6 minutes and the distance covered will be measured in feet.

Outcome measures
Measure	ConforMIS n=23 Participants Subjects in this arm will be having a ConforMIS custom total knee implant as part of standard of care. ConforMIS custom total knee
Distance Measured During 6-minute Walk Test	1060 feet Standard Deviation 373

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	ConforMIS n=28 participants at risk Subjects in this arm will receive a ConforMIS custom total knee implant. ConforMIS custom total knee	Off-the-shelf Subjects in this arm will receive an off-the-shelf total knee implant. Off-the-shelf total knee implant
Musculoskeletal and connective tissue disorders knee stiffness	3.6% 1/28 • Number of events 1 • 6 months	— 0/0 • 6 months

University of Missouri - Department of Orthopaedic Surgery

Phone: 573-882-6762