Efficacy and Safety of NAVIO

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.

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: February 2022

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.

Arms, Groups and Cohorts

  • Active Comparator: Conventional total knee arthroplasty
    • conventional total knee arthroplasty with standard intramedullary alignment guide
  • Active Comparator: NAVIO total knee arthroplasty
    • NAVIO assisted total knee arthroplasty

Clinical Trial Outcome Measures

Primary 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 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)
    • Time Frame: 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.
  • 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
    • 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.
  • 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
    • 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.
  • 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
    • Comparison is made between the two study arms, a higher visual analogue pain score means a worse outcome
  • 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
    • 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
  • 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
    • 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
    • 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
    • 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.
  • 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
    • 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 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
    • 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 positioning 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
    • 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
    • Time Frame: 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.
  • Significant difference in length of hospital stay between the two study arms
    • Time Frame: 1 day of discharge from the hospital
    • Length of hospital stay (in days) will be registered for both groups.
  • Operation Time
    • Time Frame: 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
  • Significant difference in blood loss between study arms
    • Time Frame: 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 adverse events
    • Time Frame: through study completion, an average of 10 years
    • Complication registration will be done throughout the entire study period
  • Difference in frequency of infection
    • Time Frame: 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 frequency of trombo-embolic complications
    • Time Frame: through study completion, an average of 10 years
    • Attention will be focused on clinical signs of deep vein thrombosis and pulmonary embolism.
  • Difference in frequency of wound problems
    • Time Frame: 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 frequency of loosening
    • Time Frame: through study completion, an average of 10 years.
    • Loosening of tibial or femoral components of the prosthesis as seen on X-ray.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Sint-Trudo Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Peter Bollars, Dr., Principal Investigator, Orthopedic Association Sint-Trudo Hospital
  • Overall Contact(s)
    • Peter Bollars, Dr., +3211 33 42 86, peter.bollars@stzh.be

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