Participant Flow Module
The Participant Flow Module provides information about the flow of participants through each stage of the clinical trial. This includes pre-assignment details, recruitment information, and the types of units analyzed, helping researchers understand how participants move through the study.
Participant Flow Module path is as follows:
Study -> Results Section -> Participant Flow Module
Participant Flow Module
Ignite Creation Date:
2025-12-24 @ 2:14 PM
Ignite Modification Date:
2025-12-25 @ 12:52 PM
NCT ID:
NCT00854295
Pre Assignment Details:
All cases in "Group 1" per the protocol (subjects in the previous IDE study who were eligible to participate in the PAS) have study completed and are not included in these results. A final report for Group 1 was previously approved by FDA on June 29, 2016. Since 2016, only data from Group 2 subjects (PAS Group) was reported to FDA and are applicable to this clinicatrials.gov record.
Recruitment Details:
Cases were enrolled into a short-term study (5 years) and consisted of cases eligible to receive the LPS-Flex Mobile Bearing Knee implanted by an orthopedic surgeons experienced in primary total knee replacement. Subjects who had one operative knee were in the Unilateral Group and subjects who had two operative knees were in the Bilateral Group. These subjects are considered "Group 2" per the study protocol.
Study:
NCT00854295
Study Brief:
Results Section:
NCT00854295