Osteoarthritis, KneeNCT04230616
Efficacy and Safety of NAVIO
A study testing total knee arthroplasty and CT scan in people with Osteoarthritis, Knee, run by Sint-Trudo Hospital at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- total knee arthroplasty and CT scan
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Feb 2021to Feb 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Orthopaedic Association Sint-Trudo Hospital
Sint-Truiden, Limburg, 3800
Peter Bollars, Dr., +3211334286, peter.bollars@stzh.be
About this study
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
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.
- Conditions
- Osteoarthritis, Knee
- Being tested
- total knee arthroplasty, CT scan
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
total knee arthroplastyProcedure or surgery
total knee arthroplasty
CT scanRadiation
The first 52 participants will recieve a pre- and postoperative CT scan of the hip, knee and ankle.
| Study group | Role | What they receive |
|---|---|---|
| Conventional total knee arthroplasty | Active comparator | conventional total knee arthroplasty with standard intramedullary alignment guide Receives: Procedure: total knee arthroplasty; Radiation: CT scan |
| NAVIO total knee arthroplasty | Active comparator | NAVIO assisted total knee arthroplasty Receives: Procedure: total knee arthroplasty; Radiation: CT scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: within 6 weeks pre-surgery and 6 weeks post-surgery
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
Measured: 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
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
Measured: 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
Comparison is made between the two study arms, score between 0 and 48. Better score means better outcome
Measured: 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
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.
Measured: 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)
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
Measured: 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
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.
Measured: within 6 weeks preoperative, 6 weeks post-surgery, 1 year post-surgery, 5 years post-surgery, 10 years post-surgery
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
Measured: within 6 weeks preoperative, 6 weeks post-surgery, 1 year post-surgery, 5 years post-surgery, 10 years post-surgery
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.
Measured: within 6 weeks preoperative, 6 weeks post-surgery, 1 year post-surgery, 5 years post-surgery, 10 years post-surgery
Significant difference in length of hospital stay between the two study arms
Length of hospital stay (in days) will be registered for both groups.
Measured: 1 day of discharge from the hospital
Operation Time
Compare the duration of surgery between the two study arms
Measured: intraoperative (Time will be recorded from the moment of incision until bandage is being placed)
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.
Measured: Intra-operatively until 24 hours post-surgery. .
Difference in adverse events
Complication registration will be done throughout the entire study period
Measured: through study completion, an average of 10 years
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.
Measured: through study completion, an average of 10 years
Difference in frequency of trombo-embolic complications
Attention will be focused on clinical signs of deep vein thrombosis and pulmonary embolism.
Measured: through study completion, an average of 10 years
Difference in frequency of wound problems
Persistent wound leakage will be registered. Persistent leakage is defined as leakage lasting 5 days after surgery.
Measured: From day of surgery until 5 days post-surgery
Difference in frequency of loosening
Loosening of tibial or femoral components of the prosthesis as seen on X-ray.
Measured: through study completion, an average of 10 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start1 Feb 2021
- Primary completionFeb 2022 (estimated)
- Study completionFeb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sint-Trudo Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Bollars, Dr., Principal investigator, Orthopedic Association Sint-Trudo Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04230616
- Sponsor's protocol ID
- S63149
- Status last verified
- Oct 2020
- First submitted
- 8 Jan 2020
- Last updated
- 18 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04230616
- Acronym / sponsor ID
- S63149
- Conditions
- Osteoarthritis, Knee
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Sint-Trudo HospitalUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- Feb 2022 (estimated)
- Study completion
- Feb 2030 (estimated)
- First posted
- 18 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional total knee arthroplasty | Active comparator | Procedure: total knee arthroplasty, Radiation: CT scanconventional total knee arthroplasty with standard intramedullary alignment guide |
| NAVIO total knee arthroplasty | Active comparator | Procedure: total knee arthroplasty, Radiation: CT scanNAVIO assisted total knee arthroplasty |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- Active infection in knee
- General infection
- Failure of previous joint replacement
- Post-operative or post traumatic malalignment of the knee/leg
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| total knee arthroplastytotal knee arthroplasty | Procedure or surgery | Conventional total knee arthroplasty, NAVIO total knee arthroplasty |
| CT scanThe first 52 participants will recieve a pre- and postoperative CT scan of the hip, knee and ankle. | Radiation | Conventional total knee arthroplasty, NAVIO total knee arthroplasty |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Peter Bollars, Dr. principal investigator
Orthopedic Association Sint-Trudo Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing total knee arthroplasty and CT scan in people with Osteoarthritis, Knee, run by Sint-Trudo Hospital at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Peter Bollars, Dr. (+3211 33 42 86, peter.bollars@stzh.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2021.