Efficacy and Safety of NAVIO
- Conditions
- Osteoarthritis, Knee
- Interventions
- Procedure: total knee arthroplastyRadiation: CT scan
- Registration Number
- NCT04230616
- Lead Sponsor
- Sint-Trudo Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 180
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Conventional total knee arthroplasty CT scan conventional total knee arthroplasty with standard intramedullary alignment guide NAVIO total knee arthroplasty total knee arthroplasty NAVIO assisted total knee arthroplasty NAVIO total knee arthroplasty CT scan NAVIO assisted total knee arthroplasty Conventional total knee arthroplasty total knee arthroplasty conventional total knee arthroplasty with standard intramedullary alignment guide
- Primary Outcome Measures
Name Time Method Operation Time intraoperative (Time will be recorded from the moment of incision until bandage is being placed) Compare the duration of surgery between the two study arms
Mean change in the American Knee Society Score within 6 weeks preoperative, 3 months post-surgery, 1 year post-surgery, 2 years post-surgery, 5 years post-surgery, 10 years post-surgery in a total of 50 points, stability, 25 points, and range of motion, 25 points. The maximum score of 100 points . Comparison is made between the two study arms. A higher American Knee Society Score means a better outcome
Significant difference in length of hospital stay between the two study arms 1 day of discharge from the hospital Length of hospital stay (in days) will be registered for both groups.
Difference in percentage of outliers of mechanical axis based on CT scan pre- and postoperatively (first 52 participants) within 6 weeks pre-surgery and 6 weeks post-surgery Percentage of outliers (defined as \> 3 degrees deviation from neutral) in mechanical axis of the of the operated leg. The mechanical axis is defined as the angle between a line from the centre of rotation of the hip to the centre of the femoral component and a line from the centre of the tibial plateau to the centre of the ankle.
Difference in mechanical axis of the prosthesis between the two study arms based on Long-leg X-rays within 6 weeks preoperative, 6 weeks post-surgery, 1 year post-surgery, 5 years post-surgery, 10 years post-surgery Post-operative (at 6 week visit) the baseline mechanical axis will be measured as the angle between a line connecting the center of the femoral head with the center of the knee and the line connecting the center of the knee with the center of the ankle.
Difference in frequency of wound problems From day of surgery until 5 days post-surgery Persistent wound leakage will be registered. Persistent leakage is defined as leakage lasting 5 days after surgery.
Difference in planned and achieved alignment in degrees based on CT scan pre- and postoperatively (first 52 participants) within 6 weeks pre-surgery and 6 weeks post-surgery Difference in preoperatively planned and postoperatively achieved alignment of both the femoral and tibial component of the prosthesis in the frontal, sagittal and coronal plane. Deviations (in degrees varus/valgus, flexion extension, and internal/external rotation) from calculated positions (of both components) to bony anatomic landmarks, used by NAVIO to align the prosthesis, will be obtained.
Difference in planned and achieved mechanical axis in degrees based on CT scan pre- and postoperatively (first 52 participants) within 6 weeks pre-surgery and 6 weeks post-surgery Preoperatively planned and postoperatively achieved mechanical axis of the operated leg. The mechanical axis is defined as the angle between a line from the centre of rotation of the hip to the centre of the femoral component and a line from the centre of the tibial plateau to the centre of the ankle.
Mean change in the The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) within 6 weeks preoperative, 3 months post-surgery, 1 year post-surgery, 2 years post-surgery, 5 years post-surgery, 10 years post-surgery Comparison is made between the two study arms. Five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). The higher the score, the poorer the function
Difference in frequency of infection through study completion, an average of 10 years When infection is present, this will be noted on the complication registry form and appropriate action will be taken. Distinction will be made between superficial infections and deep infections.
Difference in percentage of outliers of alignment on CT scan pre- and postoperatively (first 52 participants) within 6 weeks pre-surgery and 6 weeks post-surgery Percentage of outliers in alignment (defined as \> 3 degrees deviation from positions calculated by software) of the femoral and tibial components in frontal, sagittal and transverse plane.
Mean change in the visual analogue scale scores 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 Comparison is made between the two study arms, a higher visual analogue pain score means a worse outcome
Significant difference in blood loss between study arms Intra-operatively until 24 hours post-surgery. . Blood loss will be measured intra-operatively and up to 24 hours post-operatively.
The amount of rinsing liquid will be subtracted from the total amount collected in the suction device to obtain the amount (ml) of intra-operative blood loss. The weight of grids and compresses will be measured post-operatively and dry weight will be subtracted from this value to obtain blood loss not collected in the suction device (1mg = 1ml).
On day 2 post-operative, Hb and Ht will obtained.Difference in frequency of loosening through study completion, an average of 10 years. Loosening of tibial or femoral components of the prosthesis as seen on X-ray.
Mean change in the Oxford Knee Score within 6 weeks preoperative, 3 months post-surgery, 1 year post-surgery, 2 years post-surgery, 5 years post-surgery, 10 years post-surgery Comparison is made between the two study arms, score between 0 and 48. Better score means better outcome
Mean change in the Lower Extremities Activity scale 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 Comparison is made between the two study arms, score between 0 and 80. The minimal clinically important difference is 9 scale points. The lower the score the greater the disability.
Difference in positioning of the prosthesis between the two study arms based on Long-leg X-rays within 6 weeks preoperative, 6 weeks post-surgery, 1 year post-surgery, 5 years post-surgery, 10 years post-surgery In order to measure positioning of the prosthesis (coronal alignment), long-leg, weight-bearing, standing anteroposterior and lateral X-rays will be made
Difference in wear between the two study arms based on Long-leg X-rays within 6 weeks preoperative, 6 weeks post-surgery, 1 year post-surgery, 5 years post-surgery, 10 years post-surgery In the long term, wear can be roughly measured by measuring again the mechanical axis of the leg and comparing this with baseline mechanical axis and by measuring the distance between medial and lateral femoral condyles and medial and lateral tibial platform respectively.
Difference in adverse events through study completion, an average of 10 years Complication registration will be done throughout the entire study period
Difference in frequency of trombo-embolic complications through study completion, an average of 10 years Attention will be focused on clinical signs of deep vein thrombosis and pulmonary embolism.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Orthopaedic Association Sint-Trudo Hospital
🇧🇪Sint-Truiden, Limburg, Belgium