Osteoarthritis
Conditions
Keywords
total knee replacement, total knee arthroplasty, patient-specific
Brief summary
This study compares intraoperative fit of the patient-specific iTotal knee replacement to other standard knee replacement implants
Detailed description
The study is designed as a single center, two arm analysis. The study will be completed in two phases, based on measurement type. All additional data will be obtained from pre and post-operative subject surveys, operative and discharge records and radiographs.
Interventions
None listed
Sponsors
Restor3D
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients who are scheduled for a standard total knee replacement * Patient who are scheduled for patient-specific total knee replacement (iTotal) * Patient age \> 18 years
Exclusion criteria
* Patients who do not receive a total knee replacement * Unwilling or unable to comply with study requirements
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Phase I: Number of Participants With a Customized Tibia Implant Displaying an Overhang of 3 mm or Greater | Intraoperatively, up to 120 minutes | 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. |
| Phase II: Number of Participants With an Off-the-Shelf Implant Displaying an Overhang of 3 mm or Greater | Intraoperatively, up to 120 minutes | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 44 |
| Total | 44 |
Baseline characteristics
| Characteristic | iTotal CR TKR |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 32 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants |
| Age, Continuous | 70.48 Years |
| Sex/Gender, Customized Women | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 44 |
| serious Total, serious adverse events | 0 / 44 |
Outcome results
Primary
Phase II: Number of Participants With an Off-the-Shelf Implant Displaying an Overhang of 3 mm or Greater
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.
Time frame: Intraoperatively, up to 120 minutes
Population: 44 consecutive primary iTotal patients - number of patients with overhang of 3mm or more
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Phase I | Phase II: Number of Participants With an Off-the-Shelf Implant Displaying an Overhang of 3 mm or Greater | 8 Participants |
Primary
Phase I: Number of Participants With a Customized Tibia Implant Displaying an Overhang of 3 mm or Greater
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.
Time frame: Intraoperatively, up to 120 minutes
Population: 44 consecutive primary iTotal patients - number of patients with overhang of 3mm or more
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Phase I | Phase I: Number of Participants With a Customized Tibia Implant Displaying an Overhang of 3 mm or Greater | 0 Participants |