Knee Arthroplasty, Total
Conditions
Brief 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).
Detailed 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.
Interventions
DEVICEConforMIS custom total knee
Total knee arthroplasty using ConforMIS custom total knee system with follow-up at 6 months
Sponsors
University of Missouri-Columbia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\- undergoing total knee arthroplasty
Exclusion criteria
\- BMI \>40
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Distance Measured During 6-minute Walk Test | 6 months | Subjects will walk for 6 minutes and the distance covered will be measured in feet. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ConforMIS Subjects in this arm will be having a ConforMIS custom total knee implant as part of standard of care.
ConforMIS custom total knee | 28 |
| 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 | 0 |
| Total | 28 |
Baseline characteristics
| Characteristic | ConforMIS | Total |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 9 Participants | 9 Participants |
| Age, Categorical Between 18 and 65 years | 19 Participants | 19 Participants |
| Sex: Female, Male Female | 18 Participants | 18 Participants |
| Sex: Female, Male Male | 10 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 28 | 0 / 0 |
| serious Total, serious adverse events | 0 / 28 | 0 / 0 |
Outcome results
Primary
Distance Measured During 6-minute Walk Test
Subjects will walk for 6 minutes and the distance covered will be measured in feet.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ConforMIS | Distance Measured During 6-minute Walk Test | 1060 feet | Standard Deviation 373 |