| NCT ID | NCT04230616 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sint-Trudo Hospital |
| Condition | Osteoarthritis, Knee |
| Study Type | INTERVENTIONAL |
| Enrollment | 180 participants |
| Start Date | 2021-02-01 |
| Primary Completion | 2022-02 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 180 participants in total. It began in 2021-02-01 with a primary completion date of 2022-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Peter Bollars, Dr.
PRINCIPAL INVESTIGATOR
Orthopedic Association Sint-Trudo Hospital
Frequently Asked Questions
Who can join the NCT04230616 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Osteoarthritis, Knee. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04230616 currently recruiting?
Yes, NCT04230616 is actively recruiting participants. Contact the research team at peter.bollars@stzh.be for enrollment information.
Where is the NCT04230616 trial being conducted?
This trial is being conducted at Sint-Truiden, Belgium.
Who is sponsoring the NCT04230616 clinical trial?
NCT04230616 is sponsored by Sint-Trudo Hospital. The principal investigator is Peter Bollars, Dr. at Orthopedic Association Sint-Trudo Hospital. The trial plans to enroll 180 participants.