Arthritis Clinical Trial
Official title:
Post-Market Study of Robotic-Arm Assisted Unicompartmental Knee Arthroplasty in Comparison to Traditional UKA (Fixed and Mobile Bearings)
NCT number | NCT03447626 |
Other study ID # | 201708096 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | February 12, 2019 |
Est. completion date | April 7, 2024 |
Verified date | May 2024 |
Source | Washington University School of Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The purposes of this investigation is to 1) To determine if Robotic-arm assisted UKA (RA-UKA) allows for more accurate component placement than manual UKA (MI-UKA)and 2) prospectively assess the learning curve, radiographic, and clinical outcomes of use of the RIO system as it is incorporated into our clinical practice and compare it to historical data on manual UKAs and TKAs.
Status | Completed |
Enrollment | 486 |
Est. completion date | April 7, 2024 |
Est. primary completion date | December 12, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - All patients who receive a robotic arm assisted UKA using the RIO navigation system will be prospectively included. All patients who have received a medial fixed or mobile UKA performed by surgeons in the Joint Preservation, Resurfacing, and Replacement Service at Washington University will be retrospectively reviewed. Also, all TKAs from a pervious study (IRB 201308057) performed by surgeons in the Joint Preservation, Resurfacing, and Replacement Service at Washington University will be retrospectively reviewed as well. - Patient is willing and able to comply with postoperative follow-up requirements and self-evaluations - Patient is willing to sign an IRB approved informed consent - Patient is at least 18 years of age Exclusion Criteria: - • Patient has a BMI < 40 - Patient is skeletally immature - Patient has an active infection or suspected infection in or about the joint - Bone stock that is inadequate to support fixation of the prosthesis - Neuromuscular disorders, muscular atrophy or vascular deficiency in the affected limb rendering the procedure unjustified. - Patients with mental or neurological conditions which may be incapable of following instructions. - Blood supply limitations - Collateral ligament insufficiency. - Patients with prior HTOs or Unis. - Patients requiring bilateral knee arthroplasty. |
Country | Name | City | State |
---|---|---|---|
United States | Barnes Jewish Hospital | Saint Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
Washington University School of Medicine |
United States,
Barrett WP, Scott RD. Revision of failed unicondylar unicompartmental knee arthroplasty. J Bone Joint Surg Am. 1987 Dec;69(9):1328-35. — View Citation
Bell SW, Anthony I, Jones B, MacLean A, Rowe P, Blyth M. Improved Accuracy of Component Positioning with Robotic-Assisted Unicompartmental Knee Arthroplasty: Data from a Prospective, Randomized Controlled Study. J Bone Joint Surg Am. 2016 Apr 20;98(8):627-35. doi: 10.2106/JBJS.15.00664. — View Citation
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Tsai TY, Dimitriou D, Liow MH, Rubash HE, Li G, Kwon YM. Three-Dimensional Imaging Analysis of Unicompartmental Knee Arthroplasty Evaluated in Standing Position: Component Alignment and In Vivo Articular Contact. J Arthroplasty. 2016 May;31(5):1096-101. doi: 10.1016/j.arth.2015.11.027. Epub 2015 Nov 30. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Post Op EOS measurements for alignment | To determine if Robotic-arm assisted UKA (RA-UKA) allows for more accurate component placement than manual UKA (MI-UKA). units of measurement will be inches. | 1 day- post op |
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