Ignite Creation Date:
2025-12-24 @ 4:54 PM
Ignite Modification Date:
2026-01-04 @ 8:09 AM
Study NCT ID:
NCT05377450
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-03-26
First Post:
2022-05-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Randomized Study of Cementless vs Cemented UKA
Sponsor:
JIS Research Institute
Organization:
Study Overview
Official Title:
Prospective Randomized Study of Cementless Versus Cemented Unicompartmental Knee Arthroplasty (UKA)
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To evaluate the non-inferiority of the cementless Engage Partial Knee System compared to cemented Engage Partial knee System.
Detailed Description:
Medial unicompartmental knee arthroplasty has demonstrated outstanding success in the treatment of anteromedial osteoarthritis of the knee. Most UKA implants in the US market require cemented fixation, and there can be specific complications related to cement such as aseptic loosening between the bone-cement and/or cement-implant interface along with loose cement causing third-body wear of the remaining normal articular cartilage. Cementless devices offer a durable long-term fixation method with no risk of loose cement causing secondary damage.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: