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| Name | Class |
|---|---|
| Stryker Nordic | INDUSTRY |
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To determine if robotically-assisted UKA results in more consistent and improved component positioning and better patient reported outcome scores compared to manual TKA and MAKO TKA.
The purpose of this study is to determine the early clinical and radiographic outcomes of robotically-assisted medial unicompartmental knee arthroplasty (mUKA) with the MAKO surgical robot using the Restoris MCK Partial Implant System. The primary end point will be the mean weekly VAS pain score during the first four weeks postoperatively. The results of this study may be compared to those of previously studied cohorts of patients from this institution who underwent manual total knee arthroplasty (TKA) with the Triathlon Knee System as well as robotically-assisted total knee arthroplasty with the MAKO surgical robot using the Triathlon Knee System
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UKA MAKO | Prospective group- Patient Reported Outcomes (PROs) will be assessed using the FocusMotion app survey |
| |
| TKA MAKO | Control group-Already collected data on patient reported out comes using the FocusMotion app survey |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| focus motion knee brace | Device | knee brace that captures knee motion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient reported Questionnaires for weekly VAS pain scores up weekly | Patients will assess their weekly pain scores by filling out patient reported outcomes. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Patient will track their Opioid Consumption use by filling out a chart weekly | Patients will report their weekly use by Opioid Consumption filling out a patient diary. | 3 months |
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Inclusion Criteria:
A. Unilateral primary medial unicompartmental knee arthroplasty
B. Age 18 years of age or older
C. Willing to sign informed consent
D. Willing to return for all follow-up visits
E. Smartphone or tablet device capable of running the FocusMotion platform
Exclusion Criteria:
A. BMI > 40
B. Personal history of DVT or PE
C. Inflammatory arthritis
D. Peripheral vascular disease
E. Opioid use greater than 5 days per week
F. Nonsteroidal anti-inflammatory allergy
G. Walking aid for musculoskeletal or neurologic issue other than operative joint
H. Bilateral medial unicompartmental knee arthroplasty
I. Patient with an active infection or suspected infection in the operative joint
J. The absolute and relative contraindications stated in the FDA cleared labeling for the device
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Participants 18 years and older who have chosen to partial knee surgery using the mako robotic system.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University Medical School | St Louis | Missouri | 63110 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29954217 | Background | Kayani B, Konan S, Tahmassebi J, Pietrzak JRT, Haddad FS. Robotic-arm assisted total knee arthroplasty is associated with improved early functional recovery and reduced time to hospital discharge compared with conventional jig-based total knee arthroplasty: a prospective cohort study. Bone Joint J. 2018 Jul;100-B(7):930-937. doi: 10.1302/0301-620X.100B7.BJJ-2017-1449.R1. | |
| 17403800 |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| Result |
| Kurtz S, Ong K, Lau E, Mowat F, Halpern M. Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. J Bone Joint Surg Am. 2007 Apr;89(4):780-5. doi: 10.2106/JBJS.F.00222. |
| 32618922 | Result | Kazarian GS, Barrack TN, Okafor L, Barrack RL, Nunley RM, Lawrie CM. High Prevalence of Radiographic Outliers and Revisions with Unicompartmental Knee Arthroplasty. J Bone Joint Surg Am. 2020 Jul 1;102(13):1151-1159. doi: 10.2106/JBJS.19.01277. |
| 27067170 | Result | Nam D, Berend ME, Nunley RM, Della Valle CJ, Berend KR, Lombardi AV, Barrack RL. Residual Symptoms and Function After Unicompartmental and Total Knee Arthroplasty: Comparable to Normative Controls? J Arthroplasty. 2016 Oct;31(10):2161-6. doi: 10.1016/j.arth.2016.02.064. Epub 2016 Mar 10. |
| 29389790 | Result | Lee BS, Cho HI, Bin SI, Kim JM, Jo BK. Femoral Component Varus Malposition is Associated with Tibial Aseptic Loosening After TKA. Clin Orthop Relat Res. 2018 Feb;476(2):400-407. doi: 10.1007/s11999.0000000000000012. |
| D012216 |
| Rheumatic Diseases |