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Efficacy and Safety of NAVIO

RECRUITINGN/ASponsored by Sint-Trudo Hospital
Actively Recruiting
PhaseN/A
SponsorSint-Trudo Hospital
Started2021-02-01
Est. completion2022-02
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT04230616

Summary

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.

Eligibility

Age: 18 Years+Healthy volunteers accepted
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

Conditions2

ArthritisOsteoarthritis, Knee

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