Clinical trial NCT04230616: Efficacy and Safety of NAVIO
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Osteoarthritis, Knee
Lead sponsor: Sint-Trudo Hospital
Sponsor class: OTHER
First posted: 2020-01-18
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Primary outcomes:
measure: Difference in planned and achieved alignment in degrees based on CT scan pre- and postoperatively (first 52 participants)
timeFrame: within 6 weeks pre-surgery and 6 weeks post-surgery
measure: Difference in planned and achieved mechanical axis in degrees based on CT scan pre- and postoperatively (first 52 participants)
timeFrame: within 6 weeks pre-surgery and 6 weeks post-surgery
measure: Difference in percentage of outliers of alignment on CT scan pre- and postoperatively (first 52 participants)
timeFrame: within 6 weeks pre-surgery and 6 weeks post-surgery
measure: Difference in percentage of outliers of mechanical axis based on CT scan pre- and postoperatively (first 52 participants)
timeFrame: within 6 weeks pre-surgery and 6 weeks post-surgery
measure: Mean change in the visual analogue scale scores
timeFrame: 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
measure: Mean change in the American Knee Society Score
timeFrame: within 6 weeks preoperative, 3 months post-surgery, 1 year post-surgery, 2 years post-surgery, 5 years post-surgery, 10 years post-surgery
measure: Mean change in the Oxford Knee Score
timeFrame: within 6 weeks preoperative, 3 months post-surgery, 1 year post-surgery, 2 years post-surgery, 5 years post-surgery, 10 years post-surgery
measure: Mean change in the Lower Extremities Activity scale
timeFrame: 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
measure: Mean change in the The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
timeFrame: within 6 weeks preoperative, 3 months post-surgery, 1 year post-surgery, 2 years post-surgery, 5 years post-surgery, 10 years post-surgery
measure: Difference in mechanical axis of the prosthesis between the two study arms based on Long-leg X-rays
timeFrame: within 6 weeks preoperative, 6 weeks post-surgery, 1 year post-surgery, 5 years post-surgery, 10 years post-surgery
measure: Difference in positioning of the prosthesis between the two study arms based on Long-leg X-rays
timeFrame: within 6 weeks preoperative, 6 weeks post-surgery, 1 year post-surgery, 5 years post-surgery, 10 years post-surgery
measure: Difference in wear between the two study arms based on Long-leg X-rays
timeFrame: within 6 weeks preoperative, 6 weeks post-surgery, 1 year post-surgery, 5 years post-surgery, 10 years post-surgery
measure: Significant difference in length of hospital stay between the two study arms
timeFrame: 1 day of discharge from the hospital
measure: Operation Time
timeFrame: intraoperative (Time will be recorded from the moment of incision until bandage is being placed)
measure: Significant difference in blood loss between study arms
timeFrame: Intra-operatively until 24 hours post-surgery. .
measure: Difference in adverse events
timeFrame: through study completion, an average of 10 years
measure: Difference in frequency of infection
timeFrame: through study completion, an average of 10 years
measure: Difference in frequency of trombo-embolic complications
timeFrame: through study completion, an average of 10 years
measure: Difference in frequency of wound problems
timeFrame: From day of surgery until 5 days post-surgery
measure: Difference in frequency of loosening
timeFrame: through study completion, an average of 10 years.
Secondary outcomes:
Other outcomes:
Locations:
city: Sint-Truiden
country: Belgium
facility: Orthopaedic Association Sint-Trudo Hospital
state: Limburg
Study officials:
affiliation: Orthopedic Association Sint-Trudo Hospital
name: Peter Bollars, Dr.
role: PRINCIPAL_INVESTIGATOR
References: