Back to resultsEfficacy and Safety of NAVIO
Primary Purpose
Osteoarthritis, Knee
Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
total knee arthroplasty
CT scan
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis, Knee
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
Sites / Locations
- Orthopaedic Association Sint-Trudo HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Conventional total knee arthroplasty
NAVIO total knee arthroplasty
Arm Description
conventional total knee arthroplasty with standard intramedullary alignment guide
NAVIO assisted total knee arthroplasty
Outcomes
Primary Outcome Measures
Difference in planned and achieved alignment in degrees based on CT scan pre- and postoperatively (first 52 participants)
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)
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)
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)
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
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
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
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
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)
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
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
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
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
Length of hospital stay (in days) will be registered for both groups.
Operation Time
Compare the duration of surgery between the two study arms
Significant difference in blood loss between study arms
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
Complication registration will be done throughout the entire study period
Difference in frequency of infection
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
Attention will be focused on clinical signs of deep vein thrombosis and pulmonary embolism.
Difference in frequency of wound problems
Persistent wound leakage will be registered. Persistent leakage is defined as leakage lasting 5 days after surgery.
Difference in frequency of loosening
Loosening of tibial or femoral components of the prosthesis as seen on X-ray.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04230616
Brief Title
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
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
February 2022 (Anticipated)
Study Completion Date
February 2030 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sint-Trudo Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
180 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Conventional total knee arthroplasty
Arm Type
Active Comparator
Arm Description
conventional total knee arthroplasty with standard intramedullary alignment guide
Arm Title
NAVIO total knee arthroplasty
Arm Type
Active Comparator
Arm Description
NAVIO assisted total knee arthroplasty
Intervention Type
Procedure
Intervention Name(s)
total knee arthroplasty
Intervention Description
total knee arthroplasty
Intervention Type
Radiation
Intervention Name(s)
CT scan
Intervention Description
The first 52 participants will recieve a pre- and postoperative CT scan of the hip, knee and ankle.
Primary Outcome Measure Information:
Title
Difference in planned and achieved alignment in degrees based on CT scan pre- and postoperatively (first 52 participants)
Description
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.
Time Frame
within 6 weeks pre-surgery and 6 weeks post-surgery
Title
Difference in planned and achieved mechanical axis in degrees based on CT scan pre- and postoperatively (first 52 participants)
Description
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.
Time Frame
within 6 weeks pre-surgery and 6 weeks post-surgery
Title
Difference in percentage of outliers of alignment on CT scan pre- and postoperatively (first 52 participants)
Description
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.
Time Frame
within 6 weeks pre-surgery and 6 weeks post-surgery
Title
Difference in percentage of outliers of mechanical axis based on CT scan pre- and postoperatively (first 52 participants)
Description
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.
Time Frame
within 6 weeks pre-surgery and 6 weeks post-surgery
Title
Mean change in the visual analogue scale scores
Description
Comparison is made between the two study arms, a higher visual analogue pain score means a worse outcome
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
Title
Mean change in the American Knee Society Score
Description
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
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
Title
Mean change in the Oxford Knee Score
Description
Comparison is made between the two study arms, score between 0 and 48. Better score means better outcome
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
Title
Mean change in the Lower Extremities Activity scale
Description
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.
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
Title
Mean change in the The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Description
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
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
Title
Difference in mechanical axis of the prosthesis between the two study arms based on Long-leg X-rays
Description
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.
Time Frame
within 6 weeks preoperative, 6 weeks post-surgery, 1 year post-surgery, 5 years post-surgery, 10 years post-surgery
Title
Difference in positioning of the prosthesis between the two study arms based on Long-leg X-rays
Description
In order to measure positioning of the prosthesis (coronal alignment), long-leg, weight-bearing, standing anteroposterior and lateral X-rays will be made
Time Frame
within 6 weeks preoperative, 6 weeks post-surgery, 1 year post-surgery, 5 years post-surgery, 10 years post-surgery
Title
Difference in wear between the two study arms based on Long-leg X-rays
Description
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.
Time Frame
within 6 weeks preoperative, 6 weeks post-surgery, 1 year post-surgery, 5 years post-surgery, 10 years post-surgery
Title
Significant difference in length of hospital stay between the two study arms
Description
Length of hospital stay (in days) will be registered for both groups.
Time Frame
1 day of discharge from the hospital
Title
Operation Time
Description
Compare the duration of surgery between the two study arms
Time Frame
intraoperative (Time will be recorded from the moment of incision until bandage is being placed)
Title
Significant difference in blood loss between study arms
Description
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.
Time Frame
Intra-operatively until 24 hours post-surgery. .
Title
Difference in adverse events
Description
Complication registration will be done throughout the entire study period
Time Frame
through study completion, an average of 10 years
Title
Difference in frequency of infection
Description
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.
Time Frame
through study completion, an average of 10 years
Title
Difference in frequency of trombo-embolic complications
Description
Attention will be focused on clinical signs of deep vein thrombosis and pulmonary embolism.
Time Frame
through study completion, an average of 10 years
Title
Difference in frequency of wound problems
Description
Persistent wound leakage will be registered. Persistent leakage is defined as leakage lasting 5 days after surgery.
Time Frame
From day of surgery until 5 days post-surgery
Title
Difference in frequency of loosening
Description
Loosening of tibial or femoral components of the prosthesis as seen on X-ray.
Time Frame
through study completion, an average of 10 years.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Peter Bollars, Dr.
Phone
+3211 33 42 86
Email
peter.bollars@stzh.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Bollars, Dr.
Organizational Affiliation
Orthopedic Association Sint-Trudo Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Orthopaedic Association Sint-Trudo Hospital
City
Sint-Truiden
State/Province
Limburg
ZIP/Postal Code
3800
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter Bollars, Dr.
Phone
+3211334286
Email
peter.bollars@stzh.be
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Efficacy and Safety of NAVIO
We'll reach out to this number within 24 hrs