NCT03111407

iAssist vs. Conventional Instrumentation in Total Knee Arthroplasty

Evaluation of Zimmer® iASSIST™ vs. Conventional Instrumentation in Total Knee Arthroplasty: Radiographic, Clinical and Economic Outcomes

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Zimmer, GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this prospective study is to evaluate Zimmer® iASSIST™ with respect to radiographic, clinical and economic outcomes and compared to conventional instrumentation in primary total knee arthroplasty (NexGen or Persona knee implants).

Detailed description

The study design is a prospective, multicenter, comparative outcome study. The study requires each site to obtain IRB (Institutional Review Board) approval prior to study enrollment. All potential study subjects will be required to participate in the Informed Consent Process. All study subjects will undergo preoperative clinical evaluations prior to their total knee arthroplasty. Investigators will collect clinical data for 12 months. Follow-up clinical visits include 3 and 12 months post-operatively. The primary endpoint of this study is defined as component alignment as determined using long leg X-Rays. The secondary endpoint will be to evaluate the Knee Society Score, EQ-5D (EuroQol-5Dimensions) scoring system, operating room time, blood loss and complications

Conditions

• Avascular Necrosis
• Post-traumatic; Arthrosis
• Knee Osteoarthritis

Interventions

Type	Name	Description
PROCEDURE	total knee arthroplasty	surgical procedure in which damaged parts of the knee joint are replaced with an implant.

Timeline

• Start date: 2014-04-01
• Primary completion: 2018-12-01
• Completion: 2018-12-01
• First posted: 2017-04-12
• Last updated: 2021-04-13
• Results posted: 2021-04-13

Locations

3 sites across 2 countries: Spain, Switzerland