An interventional study of robotic-assisted TKA and CI-TKA in Total Knee Anthroplasty and Robotic Surgery, sponsored by Peking University Third Hospital. Completed at 1 site in China. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-10-15.
Sponsored by Peking University Third Hospital · Not applicable, Interventional, and Treatment
This study aimed to evaluate the early clinical and radiological outcomes of robot assisted total knee arthroplasty, and to determine the efficiency and safety of its bone resection and implant positioning of the novel robot system.
144 patients undergoing primary TKA were enrolled in this prospective, multicenter RCT conducted in 3 hospitals. The primary outcome was the rate of patients whose postoperative alignment was less than 3° deviated from the planned evaluated by full-length weight-bearing X-rays of the lower limb at 12 weeks postoperatively. Secondary outcomes will include coronal and sagittal alignment of the components, operation times, blood loss, 12-week range of motion(ROM), 12-week postoperative functional outcomes and satisfaction evaluated by the American Knee Society Score (KSS) and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and adverse events (AEs).
Peking University Third Hospital is the lead sponsor of 735 studies on the registry; 262 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Robotic-assisted TKA
Procedure: robotic-assisted TKA
TKA with conventional instruments
Procedure: CI-TKA
Robotic-assisted TKA means that TKA surgery is operated with the guidance of robotic system.
TKA operated with conventional instruments
HKA outliers
the proportion of patients with a deviation of ≤ 3° between the mechanical axis (hip-knee-ankle angle, or HKA angle) measured from a full-length, frontal-view lower limb X-ray
Time frame: 12 weeks post-surgery
FFC angle
frontal femoral component (FFC) angle
Time frame: 12 weeks post-surgery
outliers of FFC angle
outliers of frontal femoral component (FFC) angle (\>3 degree)
Time frame: 12 weeks post-surgery
FTC angle
frontal tibia component (FTC) angle
Time frame: 12 weeks post-surgery
outliers of FTC angle
outliers of frontal tibia component (FTC) angle (\>3 degree)
Time frame: 12 weeks post-surgery
LFC angle
lateral femoral component (LFC) angle
Time frame: 12 weeks post-surgery
outliers of LFC angle
outliers of lateral femoral component (LFC) angle (\>3 degree)
Time frame: 12 weeks post-surgery
LTC angle
lateral tibia component (LTC) angle
Time frame: 12 weeks post-surgery
outliers of LTC angle
outliers of lateral tibia component (LTC) angle (\>3 degree)
Time frame: 12 weeks post-surgery
Surgical duration
In this study, surgical duration is defined as the time from the first incision to the completion of skin closure
Time frame: During operation
Blood loss
Postoperative blood loss is calculated using the Gross formula in this study. The Gross equation was used to calculate the total blood loss (mL) as preoperative blood volume×(preoperative HCT level-postoperative HCT level).
Time frame: 3 days after surgery
ROM
ROM refers to the maximum passive range of knee motion
Time frame: 12 weeks post-surgery
Knee Society Score (KSS)
The KSS, developed by the American Knee Society, evaluates objective knee indicators, symptoms, patient satisfaction, patient expectations, and functional activities. A total score above 85 is considered excellent, 70-84 is good, 60-69 is fair, and below 60 is poor.
Time frame: screening and 12 weeks post-surgery.
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
The WOMAC measures knee function in terms of pain, stiffness, and physical function across 25 items. Pain is assessed with five items, stiffness with two items, and physical function with 18 items. Each item is scored from 0 to 4, with higher scores indicating more severe symptoms.
Time frame: screening and 12 weeks post-surgery.
Incidence of adverse events and serious adverse events
Throughout the study, any adverse events that occurred were recorded, and the corresponding incidence was calculated. Similarly, any serious adverse events that occurred during the study were recorded, and the corresponding incidence was calculated.
Time frame: Through study completion, an average of 12 weeks
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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Peking University Third Hospital