NCT03877042

The Efficacy of Using CR and PS Prosthesis in Total Knee Replacement

The Efficacy of Using CR and PS Prosthesis in Total Knee Replacement: a Randomized, Double-blind, Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Xijing Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The investigators will investigate the efficacy of using CR and PS implants in TKA. The investigators will conduct TKA with different implants simultaneously on one patient to compare the post-operation efficacy of both implants.

Detailed description

A randomized, single-center, single group study comparing the efficacy and safety of using CR and PS implants in TKA. The investigators will conduct TKA with different implants simultaneously on one patient to compare the post-operation efficacy of both implants. Subjects will be monitored through postoperative follow-up to understand the bilateral knee condition.

Conditions

• Total Knee Arthroplasty

Interventions

Type	Name	Description
DEVICE	Cruciate-retaining (CR) prostheses	One leg is conducted TKA with Cruciate-retaining (CR) prostheses.
DEVICE	Posterior-stabilized (PS) prostheses	One leg is conducted TKA with Posterior-stabilized (PS) prostheses.

Timeline

• Start date: 2018-12-01
• Primary completion: 2021-12-01
• Completion: 2021-12-01
• First posted: 2019-03-15
• Last updated: 2019-03-15

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated device study