Trial results for a study evaluating the iTotal Knee and iPoly XE Tibial Inserts for Knee Osteoarthritis were posted on 2025-10-16. The terminated study reported a total of 0.33 device-related adverse events per patient.
Background
Osteoarthritis, particularly knee osteoarthritis, is a common degenerative joint disease causing pain and functional impairment. Total knee replacement systems are a surgical option for patients with severe osteoarthritis to alleviate symptoms and improve mobility. This study aimed to evaluate the clinical outcomes of subjects who had undergone surgery with a specific total knee replacement system.
Trial design
This prospective study, designated as Phase NA, was designed to evaluate the clinical outcomes of subjects who had recently undergone surgery with the iTotal® Cruciate Retaining (CR) Total Knee Replacement System and had iPoly XE Tibial Inserts implanted. The trial enrolled 52 subjects with Knee Osteoarthritis. The overall status of the study was TERMINATED.
Key results
The study reported on the incidence of device and procedure-related complications:
- Incidence of Device-related Complications:
- "Device Probably Related" Adverse Event: 0.02 Events per Patient
- "Device Possibly Related" Adverse Event: 0.31 Events per Patient
- "Device All Related" Adverse Event: 0.33 Events per Patient
- "Device Not Related" Adverse Event: 0.39 Events per Patient
- Incidence of Procedure-Related Complications:
- "Procedure Probably Related" Adverse Event: 0.1 Events per Patient
- "Procedure Possibly Related" Adverse Event: 0.14 Events per Patient
- "Procedure All Related" Adverse Event: 0.24 Events per Patient
- "Procedure Not Related" Adverse Event: 0.47 Events per Patient
What this means
The posted results provide data on the observed incidence of device and procedure-related complications associated with the iTotal Knee and iPoly XE Tibial Inserts in patients undergoing total knee replacement for osteoarthritis. The reported rates, such as 0.33 device-related and 0.24 procedure-related adverse events per patient, offer initial insights into the safety profile of this system within the context of this terminated study. Clinicians should consider these complication rates when evaluating the performance of such knee replacement components.
Source
The information for these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT03289754, titled "A Prospective Study to Evaluate the iTotal Knee and iPoly XE Tibial Inserts", were posted on 2025-10-16 on clinicaltrials.gov.