Unicompartmental Knee Arthroplasty
Conditions
Brief summary
The purpose of this study is to determine the survivorship rate of robotic assisted medial partial knee replacement at a two, five, and ten years.
Detailed description
The purpose of this study is to determine the survivorship rate of robotically guided MultiCompartmental Knee system (MCK) medial onlay Unicompartmental Knee Arthroplasty (UKA) implants at a two, five, and ten year follow up.
Interventions
PROCEDUREMAKOplasty® medial UKA
A robot guided medial Unicompartmental knee arthroplasty (UKA) is a procedure to replace only the medial tibiofemoral compartment of the knee.
Sponsors
Stryker Instruments
Northwest Surgical Specialists, Vancouver
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* over 21 years of age * underwent primary robotically guided UKA and received a medial MCK onlay implant by the investigating surgeon * at least 24 months post-operative
Exclusion criteria
* Patients will be excluded from participation in the study if they are cognitively unable to answer study questions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 10 Year Survivorship of Components | 10 years after surgery | Survivorship of components is defined as knee implant device(s) remaining in patient. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 5 Year Survivorship of Components | 5 years after surgery | Survivorship of components is defined as knee implant device(s) remaining in patient. |
| 2 Year Survivorship of Components | 2 years after surgery | Survivorship of components is defined as knee implant device(s) remaining in patient. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from 179 subjects who received a robotically guided medial unicompartmental knee arthroplasty (UKA) by the investigating surgeon and were at least 2 years post-operation as of December 30, 2011. Of the 179 subjects contacted by post card and/or a phone call 145 agreed to participate in the study.
Participants by arm
| Arm | Count |
|---|---|
| Robot Assisted Medial Partial Knee Replacement Patients knees that have received a MAKOplasty® robotically guided unicompartmental knee arthroplasty (UKA) and received a medial MCK onlay implant.
MAKOplasty® medial UKA: A robot guided medial Unicompartmental knee arthroplasty (UKA) is a procedure to replace only the medial tibiofemoral compartment of the knee. | 145 |
| Total | 145 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 8 |
| Overall Study | Lost to Follow-up | 22 |
Baseline characteristics
| Characteristic | Robot Assisted Medial Partial Knee Replacement | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 71 Participants | — |
| Age, Categorical Between 18 and 65 years | 74 Participants | — |
| Age, Continuous | 64.98 years STANDARD_DEVIATION 8.67 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 145 Participants | — |
| Sex: Female, Male Female | 65 Participants | — |
| Sex: Female, Male Male | 80 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 8 / 145 |
| other Total, other adverse events | 0 / 145 |
| serious Total, serious adverse events | 0 / 145 |
Outcome results
Primary
10 Year Survivorship of Components
Survivorship of components is defined as knee implant device(s) remaining in patient.
Time frame: 10 years after surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MAKOplasty® Medial UKA | 10 Year Survivorship of Components | 110 Participants |
Secondary
2 Year Survivorship of Components
Survivorship of components is defined as knee implant device(s) remaining in patient.
Time frame: 2 years after surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MAKOplasty® Medial UKA | 2 Year Survivorship of Components | 144 Participants |
Secondary
5 Year Survivorship of Components
Survivorship of components is defined as knee implant device(s) remaining in patient.
Time frame: 5 years after surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MAKOplasty® Medial UKA | 5 Year Survivorship of Components | 132 Participants |