iTotal Pilot Study of ConforMIS Custom Total Knee Implant

University of Missouri (MU)

Status: Completed

Conditions: Knee Arthroplasty, Total

Treatments: Device: ConforMIS custom total knee

Study type: Interventional

Funder types: Other

Identifiers

NCT02186587

1206872

Details and patient eligibility

About

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).

Full description

The experimental design was changed based on enrollment hurdles to be a single cohort observational study where ConforMIS patients were enrolled and followed for 6 months with 6 minute walk used as the primary outcome measure.

Enrollment: 28 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• undergoing total knee arthroplasty

Exclusion criteria

• BMI >40

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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28 participants in 1 patient group

ConforMIS

Other group

Description:

Subjects who receive a ConforMIS custom total knee implant.

Treatment:

Device: ConforMIS custom total knee