NCT05377450

Prospective Randomized Study of Cementless vs Cemented UKA

Prospective Randomized Study of Cementless Versus Cemented Unicompartmental Knee Arthroplasty (UKA)

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 108 (estimated)
• Sponsor: JIS Research Institute · Academic / Other
• Sex: All
• Age: 21 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Osteoarthritis, Knee

Interventions

Type	Name	Description
DEVICE	Engage Partial Knee	Unicompartmental knee arthroplasty utilizing the Engage Partial Knee system with bone cement.
DEVICE	Engage Partial Knee	Unicompartmental knee arthroplasty utilizing the Engage Partial Knee system without bone cement.

Timeline

• Start date: 2022-08-29
• Primary completion: 2025-05-01
• Completion: 2025-05-01
• First posted: 2022-05-17
• Last updated: 2025-03-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study