Washington University School of Medicine
Creve Coeur, Missouri, 63141, United States
NCT Number: NCT05744895
The purpose of this study is to determine the early clinical and radiographic outcomes of robotically assisted total knee arthroplasty with the MAKO surgical robot using the Triathlon knee system. Results of this study will be compared to those of a previously published cohort of patients from this institution who underwent TKA using non-robotic, manual instruments.
MAKO TKA patients will be given Fitbits and the Focus Motion Knee Brace to capture the data listed in attachment section. The results of this data will be compared to the control group to see if there is or there is not a difference in clinical outcomes with patients receiving Total knee surgery using the MAKO surgical robot versus those who got Total knee surgery without the MAKO robot.
Looking for future studies?
Notify Me18 year and older
All sexes
Observational
Creve Coeur, Missouri, 63141, United States
Research objectives:
The purpose of this study is to determine the early clinical and radiographic outcomes of robotically assisted total knee arthroplasty with the MAKO surgical robot using the Triathlon knee system. Mean weekly VAS pain score during the first 4 weeks is the primary end point. Results of this study will be compared to prospective cohort of patients in the IRB study 201805014 from this institution who underwent TKA using non-robotic, manual instruments
Primary Hypothesis: Patients receiving robotic TKA will have better early recovery, including lower mean weekly VAS pain score for the first 4 weeks postoperatively and higher functional outcome scores, than the manual TKA historical cohort.
Secondary Hypothesis:
Patients receiving robotic TKA will have more accurate component position and alignment than the manual TKA historical cohort.
Potential Contribution: This study would give us a better understanding of the clinical and radiographic outcomes of patients receiving robotic TKA versus manual TKA. It will identify potential advantages and disadvantages of robotic TKA using the MAKO surgical robot.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Prospective TKA patient receiving total knee arthroplasty using the MAKO robotic machine
Focusmotion knee brace measures range of motion during exercises
Fitbit will measure patients steps, HR, and sleep
Will survey patients with PROMS
Time frame: 1 week
To determine if Robotic-arm assisted TKA (RA-TKA) allows for earlier recovery than manual TKA (MI-TKA). This will be measured by weekly VAS pain score.
VAS scale 0-10 (0= no pain, 10=extreme pain)
Time frame: 1 year
To determine if Robotic-arm assisted TKA (RA-TKA) allows for more accurate component placement than manual TKA (MI-TKA). units of measurement will be inches.
Washington University School of Medicine
Other
Early Outcomes of Total Knee Arthroplasty Using the MAKO Surgical Robot and Triathlon Knee
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07364578
Arthritis, Joint Diseases
Banī Suwayf, Egypt
View Trial DetailsNCT03895489
Arthritis, Joint Diseases
Edmonton, Alberta, Canada
View Trial DetailsNCT06693648
Arthritis, Joint Diseases
Thousand Oaks, California, United States
View Trial DetailsNCT06522906
Arthritis, Behavior
Tucson, Arizona, United States
View Trial Details