Trial Outcomes & Findings for A Retrospective Study of the iTotal CR Knee Replacement System (NCT NCT01564654)

NCT ID: NCT01564654

Last Updated: 2023-10-25

Results Overview

Range of Motion

• Recruitment status: COMPLETED
• Target enrollment: 89 participants
• Primary outcome timeframe: Average of 7 months post-operative
• Results posted on: 2023-10-25

Participant Flow

Participant milestones

Measure	iTotal KRS iTotal KRS: Total Knee Replacement System
Overall Study STARTED	89
Overall Study COMPLETED	89
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Retrospective Study of the iTotal CR Knee Replacement System

Baseline characteristics by cohort

Measure	iTotal KRS n=89 Participants iTotal KRS: Total Knee Replacement System
Age, Customized Mean age at surgery	68 years n=113 Participants
Sex: Female, Male Female	53 Participants n=113 Participants
Sex: Female, Male Male	36 Participants n=113 Participants

PRIMARY outcome

Timeframe: Average of 7 months post-operative

Range of Motion

Outcome measures

Measure	iTotal KRS n=89 Participants iTotal KRS: Total Knee Replacement System
Knee Function	113 degrees Interval 65.0 to 140.0

SECONDARY outcome

Timeframe: Average of 7 months

Population: bilaterals were included

Number of knees that required a reoperation to remove/replace/add implant components

Outcome measures

Measure	iTotal KRS n=106 Knees iTotal KRS: Total Knee Replacement System
Revision Rate	1 Knees

SECONDARY outcome

Timeframe: Initial hospital stay

Number of knees that required a blood transfusion during the initial hospital stay post-operative

Outcome measures

Measure	iTotal KRS n=106 Knees iTotal KRS: Total Knee Replacement System
Number of Transfusions	0 number of knees requiring transfusion

SECONDARY outcome

Timeframe: Up to 7 months post-operative

Number of knees that required a subsequent procedure to restore knee range of motion

Outcome measures

Measure	iTotal KRS n=106 Knees iTotal KRS: Total Knee Replacement System
Manipulations Under Anesthesia	4 Knees

Adverse Events

iTotal KRS

Serious events: 5 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	iTotal KRS n=89 participants at risk iTotal KRS: Total Knee Replacement System
Surgical and medical procedures Manipulations	4.5% 4/89 • Number of events 4
Surgical and medical procedures Revision/Poly Swap	1.1% 1/89 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

Marc Quartulli, VP Clinical Affairs

ConforMIS

Phone: 781-345-9191

Email: marc.quartulli@conformis.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60