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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ConforMIS | Other | Subjects who receive a ConforMIS custom total knee implant. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ConforMIS custom total knee | Device | Total knee arthroplasty using ConforMIS custom total knee system with follow-up at 6 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Distance Measured During 6-minute Walk Test | Subjects will walk for 6 minutes and the distance covered will be measured in feet. | 6 months |
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Inclusion Criteria:
- undergoing total knee arthroplasty
Exclusion Criteria:
- BMI >40
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| Name | Affiliation | Role |
|---|---|---|
| Sonny Bal, MD | Professor - PI | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Missouri Orthopaedic Institute | Columbia | Missouri | 65212 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | ConforMIS | Subjects in this arm will receive a ConforMIS custom total knee implant. ConforMIS custom total knee |
| FG001 | Off-the-shelf | Subjects in this arm will receive an off-the-shelf total knee implant. Off-the-shelf total knee implant |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ConforMIS | Subjects in this arm will be having a ConforMIS custom total knee implant as part of standard of care. ConforMIS custom total knee |
| BG001 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Distance Measured During 6-minute Walk Test | Subjects will walk for 6 minutes and the distance covered will be measured in feet. | Posted | Mean | Standard Deviation | feet | 6 months |
|
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ConforMIS | Subjects in this arm will receive a ConforMIS custom total knee implant. ConforMIS custom total knee |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| knee stiffness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sonny B. Bal, MD, PI | University of Missouri - Department of Orthopaedic Surgery | 573-882-6762 | BalB@health.missouri.edu |
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| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
| 0 |
| 28 |
| 1 |
| 28 |
| EG001 | Off-the-shelf | Subjects in this arm will receive an off-the-shelf total knee implant. Off-the-shelf total knee implant | 0 | 0 | 0 | 0 |
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