Efficacy and Safety of NAVIO

Sint-Trudo Hospital

Status: Enrolling

Conditions: Osteoarthritis, Knee

Treatments: Radiation: CT scan; Procedure: total knee arthroplasty

Study type: Interventional

Funder types: Other

Identifiers

NCT04230616

S63149

Details and patient eligibility

About

The goal of the study is to compare the efficacy, safety and costs of the NAVIO™ system with the conventional intramedullary alignment guide for total knee replacement in a clinical setting. The hypothesis is that total knee arthroplasty (TKA) with the use of NAVIO™ is at least as efficient and safe as TKA with the use of conventional intramedullary alignment guiding.

Enrollment: 180 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Painful and disabled knee joint resulting from osteoarthritis where one or more compartments are involved, as assessed by X-ray
• High need to obtain pain relief and improve function
• Above 18 years old
• Able and willing to follow instructions
• Informed consent

Exclusion criteria

• Active infection in knee
• General infection
• Failure of previous joint replacement
• Post-operative or post traumatic malalignment of the knee/leg
• Pregnancy
• Not able or willing to undergo CT-scan

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

180 participants in 2 patient groups

Conventional total knee arthroplasty

Active Comparator group

Description:

conventional total knee arthroplasty with standard intramedullary alignment guide

Treatment:

Radiation: CT scan

Procedure: total knee arthroplasty

NAVIO total knee arthroplasty

Active Comparator group

Description:

NAVIO assisted total knee arthroplasty

Treatment:

Radiation: CT scan

Procedure: total knee arthroplasty