Ignite Creation Date:
2024-10-25 @ 7:53 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06638047
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-10-06
Brief Title:
Early Clinical and Radiological Outcomes of a Novel Robotic TKA System
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Early Clinical and Radiological Outcomes of a Novel Robotic TKA System
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RA-TKA
Brief Summary:
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 motionROM 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
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 motionROM 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None