Osteo Arthritis KneeNCT03286868
Balancing Kinematically Aligned Total Knee Replacements During Total Primary Knee Arthroplasty Using Verasense
A study testing Total Knee Arthroplasty and Total Knee Arthroplasty with Verasense sensor in people with Osteo Arthritis Knee, run by Nova Scotia Health Authority at 1 site in Canada.
Trial summary
Total Knee Replacement (TKR) is an operation to help with the pain and decreased function that happens with end stage arthritis of the knee. This operation has been shown to be very successful at relieving pain and improving patient mobility; however, some studies have shown that up to 20% of TKR recipients are not… Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Osteo Arthritis Knee
- What is being tested?
- Total Knee Arthroplasty and Total Knee Arthroplasty with Verasense sensor
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 23 Jul 2018to Sep 2026
- 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 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptomatic arthritis of the knee indicating primary total knee arthroplasty
- Between the ages of 21 and 80 inclusive
- Patients willing and able to comply with follow-up requirements and self-evaluations
- Ability to give informed consent
- Varus alignment
Who cannot join
- Patients less than 21 years of age, or 81 years of age and older
- Unable to provide consent
- BMI >45
- Pregnancy
- Patients with inflammatory arthritis, posttraumatic osteoarthritis, post high tibial osteotomy, or arthritis due to sepsis will be excluded.
- Active or prior infection
Show all 11Show fewer
- Medical condition precluding major surgery
- Severe osteoporosis or osteopenia
- Neuromuscular impairment
- Significant co-morbidity affecting ability to ambulate
- Valgus alignment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Nova Scotia Health Authority
Halifax, Nova Scotia, B3H 3A7
Elise Laende, 902-473-3883
Michael Dunbar
About this study
Total Knee Replacement (TKR) is an operation to help with the pain and decreased function that happens with end stage arthritis of the knee. This operation has been shown to be very successful at relieving pain and improving patient mobility; however, some studies have shown that up to 20% of TKR recipients are not happy with their knee replacement.
All of the reasons why some patients are not pleased with the outcome of surgery are not known, but one of the possible causes is the way the implants are placed, or aligned, during surgery. Most TKRs are aligned in a fashion that the bones in the leg are completely straight after surgery. This is known as mechanically aligning a TKR. A different alignment method known as kinematic alignment respects the natural bow legged or knock kneed alignment of the patient. It is hoped that kinematically aligning a knee replacement will improve how the knee feels to the patient and therefore improve their satisfaction.
Read more
Another potential factor affecting the outcomes of TKR is obtaining optimal soft tissue balance. The challenge with balancing a TKR is that traditional operative techniques rely on subjective feel of the knee stability during surgery. The balance or tension in the knee can however be objectively measured using specialized intraoperative pressure sensing devices.
The purpose of this study is to assess the impact of kinematically aligned TKR on the pressures measured by Verasense during total knee replacements. The study will also determine if differences in the pressure measured during TKR surgery impact patient outcomes after surgery.
Read the detailed description
The primary objective of this research study is to evaluate the use of the Verasense pressure sensor to optimize intraoperative implant pressures/balance during computer assisted TKR utilizing pre- and postoperative kinematic alignment techniques.
This is a randomized controlled trial where 60 patients will undergo a kinematically aligned TKR using VERASENSE pressure sensors. Patients will be randomly assigned to either TKR balancing using VERASENSE data (TKR-V), or TKR using standard surgeon decision making in balancing (TKR only). In the TKR only group, the surgeon will perform the surgery while blinded to the data output of the VERASENSE sensor and will use standard surgeon decision making to balance the TKR. In the second group, TKR-V, the surgeon will not be blinded to the data output of the VERASENSE sensor and will use the data to influence how they balance the TKR.
The primary outcome measure will be postoperative kinematic gait assessment to evaluate the effect of optimizing patient soft tissue balance using Verasense pressure sensor. Secondary outcomes will include the number of intraoperative soft tissue releases, and results of health outcome questionnaires.
Research Questions:
- What are the differences and similarities between the subjective surgeon-balanced group (standard of care) compared to the objective Verasense-balanced group?
- Is there a difference in the number of "poorly balanced" knees between the surgeon-balanced kinematically aligned groups compared to the Verasense-balanced kinematically aligned group?
- Is there an effect of preoperative alignment on ligament balancing using Verasense pressure sensor?
- Is there a difference in the number of ligament releases required to optimize soft tissue balance between the Verasense pressure sensor aided total knee replacements and those balanced by the surgeon alone?
- What is the effect of optimizing patient soft tissue balance with Verasenes pressure sensor on gait parameters measured with Knee KG?
ANOVA will be used to examine pre and post-operative differences in specific features of knee kinematics between groups. Primary and secondary outcomes will be evaluated using listings and summary statistics. Improvement in pain and function will be analyzed using t-test or Wilcoxon Rank tests.
- Conditions
- Osteo Arthritis Knee
- Being tested
- Total Knee Arthroplasty, Total Knee Arthroplasty with Verasense sensor
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
Total Knee Arthroplasty with Verasense sensorDevice
Total Knee Arthroplasty with Verasense sensor
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care TKA | Placebo comparator | Standard of Care Total Knee Arthroplasty (TKA): No data from the Verasense sensor will be used to influence the surgery Receives: Procedure: Total Knee Arthroplasty |
| TKA with Verasense sensor | Experimental | Total Knee Arthroplasty (TKA) with Verasense sensor for Intraoperative Balancing: Surgeon will attempt to optimize the intraoperative pressures using the data from the Verasense sensor Receives: Device: Total Knee Arthroplasty with Verasense sensor |
What is being measured
The primary outcome is the main question the study is designed to answer.
gait assessment
kinematic gait assessment using KneeKG
Measured: 2 years
Secondary outcomes (2)
EQ-5D patient reported outcome measure
Health status measure
Measured: 2 years
Ligament releases
Number of ligament releases required during knee replacement
Measured: Intra-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2017
- Study start23 Jul 2018
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteo Arthritis 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
- Model description
- Randomized controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03286868
- Sponsor's protocol ID
- TKA VERA
- Status last verified
- Jan 2025
- First submitted
- 30 Aug 2017
- Last updated
- 17 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Balancing Kinematically Aligned Total Knee Replacements During Total Primary Knee Arthroplasty Using Verasense
- ClinicalTrials.gov ID
- NCT03286868
- Acronym / sponsor ID
- TKA VERA
- Conditions
- Osteo Arthritis Knee
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Study start
- 23 Jul 2018 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 19 Sep 2017 (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.
Total Knee Replacement (TKR) is an operation to help with the pain and decreased function that happens with end stage arthritis of the knee. This operation has been shown to be very successful at relieving pain and improving patient mobility; however, some studies have shown that up to 20% of TKR recipients are not happy with their knee replacement.
All of the reasons why some patients are not pleased with the outcome of surgery are not known, but one of the possible causes is the way the implants are placed, or aligned, during surgery. Most TKRs are aligned in a fashion that the bones in the leg are completely straight after surgery. This is known as mechanically aligning a TKR. A different alignment method known as kinematic alignment respects the natural bow legged or knock kneed alignment of the patient. It is hoped that kinematically aligning a knee replacement will improve how the knee feels to the patient and therefore improve their satisfaction.
Another potential factor affecting the outcomes of TKR is obtaining optimal soft tissue balance. The challenge with balancing a TKR is that traditional operative techniques rely on subjective feel of the knee stability during surgery. The balance or tension in the knee can however be objectively measured using specialized intraoperative pressure sensing devices.
The purpose of this study is to assess the impact of kinematically aligned TKR on the pressures measured by Verasense during total knee replacements. The study will also determine if differences in the pressure measured during TKR surgery impact patient outcomes after surgery.
Detailed description
The primary objective of this research study is to evaluate the use of the Verasense pressure sensor to optimize intraoperative implant pressures/balance during computer assisted TKR utilizing pre- and postoperative kinematic alignment techniques.
This is a randomized controlled trial where 60 patients will undergo a kinematically aligned TKR using VERASENSE pressure sensors. Patients will be randomly assigned to either TKR balancing using VERASENSE data (TKR-V), or TKR using standard surgeon decision making in balancing (TKR only). In the TKR only group, the surgeon will perform the surgery while blinded to the data output of the VERASENSE sensor and will use standard surgeon decision making to balance the TKR. In the second group, TKR-V, the surgeon will not be blinded to the data output of the VERASENSE sensor and will use the data to influence how they balance the TKR.
The primary outcome measure will be postoperative kinematic gait assessment to evaluate the effect of optimizing patient soft tissue balance using Verasense pressure sensor. Secondary outcomes will include the number of intraoperative soft tissue releases, and results of health outcome questionnaires.
Research Questions:
- What are the differences and similarities between the subjective surgeon-balanced group (standard of care) compared to the objective Verasense-balanced group?
- Is there a difference in the number of "poorly balanced" knees between the surgeon-balanced kinematically aligned groups compared to the Verasense-balanced kinematically aligned group?
- Is there an effect of preoperative alignment on ligament balancing using Verasense pressure sensor?
- Is there a difference in the number of ligament releases required to optimize soft tissue balance between the Verasense pressure sensor aided total knee replacements and those balanced by the surgeon alone?
- What is the effect of optimizing patient soft tissue balance with Verasenes pressure sensor on gait parameters measured with Knee KG?
ANOVA will be used to examine pre and post-operative differences in specific features of knee kinematics between groups. Primary and secondary outcomes will be evaluated using listings and summary statistics. Improvement in pain and function will be analyzed using t-test or Wilcoxon Rank tests.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Standard of Care TKA | Placebo comparator | Procedure: Total Knee ArthroplastyStandard of Care Total Knee Arthroplasty (TKA): No data from the Verasense sensor will be used to influence the surgery |
| TKA with Verasense sensor | Experimental | Device: Total Knee Arthroplasty with Verasense sensorTotal Knee Arthroplasty (TKA) with Verasense sensor for Intraoperative Balancing: Surgeon will attempt to optimize the intraoperative pressures using the data from the Verasense sensor |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Symptomatic arthritis of the knee indicating primary total knee arthroplasty
- Between the ages of 21 and 80 inclusive
- Patients willing and able to comply with follow-up requirements and self-evaluations
- Ability to give informed consent
- Varus alignment
Key exclusion criteria (11 listed)
- Patients less than 21 years of age, or 81 years of age and older
- Unable to provide consent
- BMI >45
- Pregnancy
- Patients with inflammatory arthritis, posttraumatic osteoarthritis, post high tibial osteotomy, or arthritis due to sepsis will be excluded.
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 | Standard of Care TKA |
| Total Knee Arthroplasty with Verasense sensorTotal Knee Arthroplasty with Verasense sensor | Device | TKA with Verasense sensor |
Primary outcome
gait assessment
Time frame: 2 years
kinematic gait assessment using KneeKG
2 secondary outcomes
EQ-5D patient reported outcome measure
Time frame: 2 years
Ligament releases
Time frame: Intra-operative
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 17 Feb 2025.
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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.
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 Total Knee Arthroplasty with Verasense sensor in people with Osteo Arthritis Knee, run by Nova Scotia Health Authority at 1 site in Canada.
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 11 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 17 Feb 2025. 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 Canada. 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. Some participants in this study may receive a placebo. 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 Research Manager (902-473-3883, elise.laende@nshealth.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
gait assessment (time frame: 2 years). 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 17 Feb 2025.