Trial Outcomes & Findings for Study Comparing Fit of the iTotal Versus Standard Total Knee Implants (NCT NCT01861028)

Results Overview

Fit will be measured in 4 quadrants on the tibia using a ruler to measure the distance between the customized implant and the edge of the tibia.

Recruitment status

TERMINATED

Target enrollment

44 participants

Primary outcome timeframe

Intraoperatively, up to 120 minutes

Results posted on

2023-10-25

Participant milestones
Measure	iTotal CR TKR A series of 44 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
Overall Study STARTED	44
Overall Study COMPLETED	44
Overall Study NOT COMPLETED	0

Withdrawal data not reported

Study Comparing Fit of the iTotal Versus Standard Total Knee Implants

Baseline characteristics by cohort
Measure	iTotal CR TKR n=44 Participants A series of 44 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
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=99 Participants
Age, Categorical >=65 years	32 Participants n=99 Participants
Age, Continuous	70.48 Years n=99 Participants
Sex/Gender, Customized Women	17 Participants n=99 Participants

Timeframe: Intraoperatively, up to 120 minutes

Population: 44 consecutive primary iTotal patients - number of patients with overhang of 3mm or more

Fit will be measured in 4 quadrants on the tibia using a ruler to measure the distance between the customized implant and the edge of the tibia.

Outcome measures
Measure	Phase I n=44 Participants A series of 44 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 I: Number of Participants With a Customized Tibia Implant Displaying an Overhang of 3 mm or Greater	0 Participants

Timeframe: Intraoperatively, up to 120 minutes

Population: 44 consecutive primary iTotal patients - number of patients with overhang of 3mm or more

Fit will be measured in 3 quadrants on the tibia using a ruler to measure the distance between the off-the-shelf design and the edge of the tibia.

Outcome measures
Measure	Phase I n=44 Participants A series of 44 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: Number of Participants With an Off-the-Shelf Implant Displaying an Overhang of 3 mm or Greater	8 Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

Conformis

Phone: 781-345-9103