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Recruiting NCT04230616

Efficacy and Safety of NAVIO

No phase Interventional Osteoarthritis, Knee

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: total knee arthroplasty, CT scan.
Who it may be relevant to
Registry conditions: Osteoarthritis, Knee. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Comparison of Clinical Outcome and Alignment of NAVIO Total Knee Arthroplasty and Conventional Total Knee Arthroplasty A Prospective, Randomized, Controlled, Single Blind Study

Overview

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.

Interventions

  • Procedure total knee arthroplasty
    total knee arthroplasty
  • Radiation CT scan
    The first 52 participants will recieve a pre- and postoperative CT scan of the hip, knee and ankle.

Primary outcome measures

  • Difference in planned and achieved alignment in degrees based on CT scan pre- and postoperatively (first 52 participants) [Time frame: within 6 weeks pre-surgery and 6 weeks post-surgery]
  • Difference in planned and achieved mechanical axis in degrees based on CT scan pre- and postoperatively (first 52 participants) [Time frame: within 6 weeks pre-surgery and 6 weeks post-surgery]
  • Difference in percentage of outliers of alignment on CT scan pre- and postoperatively (first 52 participants) [Time frame: within 6 weeks pre-surgery and 6 weeks post-surgery]
  • Difference in percentage of outliers of mechanical axis based on CT scan pre- and postoperatively (first 52 participants) [Time frame: within 6 weeks pre-surgery and 6 weeks post-surgery]
  • Mean change in the visual analogue scale scores [Time frame: within 6 weeks preoperative, 24 hours post-surgery, day of discharge, 6 weeks post-surgery, 3 months post-surgery, 1 year post-surgery, 2 years post-surgery, 5 years post-surgery, 10 years post-surgery]
  • Mean change in the American Knee Society Score [Time frame: within 6 weeks preoperative, 3 months post-surgery, 1 year post-surgery, 2 years post-surgery, 5 years post-surgery, 10 years post-surgery]
  • Mean change in the Oxford Knee Score [Time frame: within 6 weeks preoperative, 3 months post-surgery, 1 year post-surgery, 2 years post-surgery, 5 years post-surgery, 10 years post-surgery]
  • Mean change in the Lower Extremities Activity scale [Time frame: within 6 weeks preoperative, day of discharge, 6 weeks post-surgery, 3 months post-surgery, 1 year post-surgery, 2 years post-surgery, 5 years post-surgery, 10 years post-surgery]
  • Mean change in the The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) [Time frame: within 6 weeks preoperative, 3 months post-surgery, 1 year post-surgery, 2 years post-surgery, 5 years post-surgery, 10 years post-surgery]
  • Difference in mechanical axis of the prosthesis between the two study arms based on Long-leg X-rays [Time frame: within 6 weeks preoperative, 6 weeks post-surgery, 1 year post-surgery, 5 years post-surgery, 10 years post-surgery]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Belgium · 1 center
  • Orthopaedic Association Sint-Trudo Hospital — Sint-Truiden

Identifiers

NCT: NCT04230616 · S63149

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗