Total Knee ArthroplastyNCT02976428
Conventional vs. Sensor Guided Soft Tissue Balancing in TKA RCT
A study testing Sensor Guided Soft Tissue Balancing and Standard Soft Tissue Balancing in people with Total Knee Arthroplasty, run by Hamilton Health Sciences Corporation at 1 site in Canada.
Trial summary
To ensure a successful outcome after total knee replacement (TKR) soft tissue balance and proper implant position are very important during the surgical procedure. Soft tissues are structures in the knee including ligaments, muscles, tendons, and menisci that stabilize and cushion the knee joint. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Knee Arthroplasty
- What is being tested?
- Sensor Guided Soft Tissue Balancing and Standard Soft Tissue Balancing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 1 siteCanada
- Study dates
- 1 Feb 2017to 3 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Patients scheduled to undergo elective primary unilateral TKR for a diagnosis of osteoarthritis to be performed at the study site by the primary investigators
- Willingness and ability to give informed consent.
Who cannot join
- Inflammatory arthropathy
- Ligament insufficiencies
- Contraindications to posterior cruciate retaining TKR including: deformity >15 degrees or fixed-flexion contracture >15 degrees
- Previous high tibial osteotomy
- Scheduled to undergo sequential bilateral TKR under one anesthetic
- Scheduled to undergo revision TKR surgery
Show all 13Show fewer
- Neuromuscular disorder limiting mobility or ability to comply with physiotherapy
- Previous recurrent deep knee infection
- Major bone loss requiring structural bone graft or augmented components
- Functionally limiting peripheral vascular disease
- Patients receiving associated worker's compensation benefits (WSIB)
- Ethanol/drug abuse/psychiatric disorder
- Inability or unwillingness to give written informed consent to participate
Trial locations and contacts
1 site in 1 country.
Canada1 site
Hamilton Health Sciences Juravinski Hospital
Hamilton, Ontario, L8V 1C3
About this study
Official title: Randomized Controlled Trial of Sensor Guided Knee Balancing Compared to Standard Balancing Technique in Total Knee Arthroplasty
To ensure a successful outcome after total knee replacement (TKR) soft tissue balance and proper implant position are very important during the surgical procedure. Soft tissues are structures in the knee including ligaments, muscles, tendons, and menisci that stabilize and cushion the knee joint. Lack of proper soft tissue balance or imprecise implant positioning may result in knee stiffness, pain, instability and limited range of motion (ROM). This may result in implant failure and the need for revision surgery. As part of standard practice orthopedic surgeons use a manual knee balancer device to help guide soft tissue balancing to achieve optimal knee balance. New sensor-assisted technology can provide surgeons with measurable information to help achieve soft tissue balancing, providing surgeons with immediate visual feedback during the surgery. This feedback, transmitted wirelessly by the sensor, gives surgeons electronic information on soft tissue balance and implant position.The purpose of this study is to determine if a sensor guided soft tissue balancing device (Verasense) is more effective at balancing the knee during surgery as compared to standard soft tissue balancing performed with a manual balancer device.
Read the detailed description
The study is that of a prospective double-blind randomized controlled trial of patients presenting for elective primary TKR to compare the outcomes of TKR using conventional soft tissue balancing with a tensiometer device versus augmenting the soft tissue balancing with the OrthoSensor VerasenseTM sensor device. The primary outcome will be rate of unbalanced TKRs based on the quantitative Verasense definition of a well balanced knee defined as a mediolateral intercompartmental loading difference of ≤15 pounds through ROM. Secondary outcomes include differences in clinical outcome scores and patient satisfaction among sensor guided cases and controls.
Patients will be randomized to receive TKR with the Triathlon total knee system (Stryker) in the case and control group according to: (1) control group with standard balancing techniques used and sensor data obtained in blinded fashion and not used to balance the TKR implant, (2) experimental case group with sensor guided balancing where sensor data is used to balance the TKR within defined parameters.
- Conditions
- Total Knee Arthroplasty
- Being tested
- Sensor Guided Soft Tissue Balancing, Standard Soft Tissue Balancing
- Keywords
- knee soft tissue balancing, sensor-guided, range of motion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensor Guided Soft Tissue BalancingProcedure or surgery
Also called Triathlon (Stryker, Mahwah, NJ), Verasense (OrthoSensor Inc., Dania Beach, FL)
Primary TKR with soft tissue balancing with a sensor guided device.
Standard Soft Tissue BalancingProcedure or surgery
Also called Triathlon (Stryker, Mahwah, NJ)
Primary TKR with soft tissue balancing with a standard of care manual tensiometer device.
| Study group | Role | What they receive |
|---|---|---|
| Standard Soft Tissue Balancing | Active comparator | In the control group where the sensor device is not used in optimization of knee balance and alignment, definitive implants will be cemented in place and the sensor trial inserted using a thickness based on prior standard bearing insert trialing. Peak load data will be captured intraoperatively through full ROM. Custom shims will be affixed to the sensor to replicate thickness of the standard trial. The knee will then be cycled and loads recorded in the medial and lateral compartments at 10, 45 and 90 degrees of flexion. The surgeon will be blinded to the sensor output and the system will be located outside of their visual field. Receives: Procedure: Standard Soft Tissue Balancing |
| Sensor Guided Soft Tissue Balancing | Experimental | In the experimental group where the sensor device is used to optimize balance and alignment, the sensor trial will be inserted and tibial baseplate rotated until medial and lateral femoral contact points are parallel on the sensor output. Quantitative balance is defined as a mediolateral intercompartmental loading difference of ≤15 pounds. Flexion balance is achieved when femoral contact point position is within the midposterior third of the tibial insert and intercompartmental loads are balanced. Loads in the medial and lateral compartments are recorded at 10, 45 and 90 degrees. If compartment loads differ by >15 lbs between compartments, unbalanced, further soft tissue release/bone resection will be done to achieve a side to side compartment pressure difference of <15 lbs through ROM. Receives: Procedure: Sensor Guided Soft Tissue Balancing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Unbalanced TKRs
The rate of unbalanced TKRs will be assessed based on the Verasense sensor device quantitative definition of a well balanced knee. A well balanced knee is defined as having a mediolateral intercompartmental loading difference of ≤15 pounds through ROM [Gustke et al., Walker et al].
Measured: Intraoperative at end of procedure prior to wound closure
Secondary outcomes (8)
Knee Society Score
Overall clinical function as measured by Knee Society Score
Measured: Preoperative, 6 weeks, 6 months and 1 year postoperative
Oxford Knee Score
Subjective function as measured by Oxford Knee Score patient report outcome measure
Measured: Preoperative, 6 weeks, 6 months and 1 year postoperative
Patient satisfaction
Patient satisfaction with total knee replacement; likert scale
Measured: 1 year postoperative
Clinical knee function: varus/valgus alignment
Assessment of clinical knee function
Measured: Preoperative, intraoperative, 6 weeks, 6 months and 1 year postoperative
Clinical knee function: anteroposterior stability
Assessment of clinical knee function
Measured: Preoperative, intraoperative, 6 weeks, 6 months and 1 year postoperative
Clinical knee function: extension lag
Assessment of clinical knee function
Measured: Preoperative, intraoperative, 6 weeks, 6 months and 1 year postoperative
Clinical knee function: anatomic alignment
Assessment of clinical knee function
Measured: Preoperative, intraoperative, 6 weeks, 6 months and 1 year postoperative
Clinical knee function: knee ROM
Assessment of clinical knee function
Measured: Preoperative, intraoperative, 6 weeks, 6 months and 1 year postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2016 (estimated)
- Study start1 Feb 2017
- Primary completion15 May 2018
- Study completion3 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Total Knee ArthroplastyStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mitch Winemaker, Hamilton Health Sciences Corporation
- Investigators
- Mitch Winemaker, MD, FRCSC, Principal investigator, Hamilton Health Sciences Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02976428
- Sponsor's protocol ID
- HAGRP01
- Status last verified
- Aug 2022
- First submitted
- 22 Nov 2016
- Last updated
- 1 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gustke KA, Golladay GJ, Roche MW, Elson LC, Anderson CR. A new method for defining balance: promising short-term clinical outcomes of sensor-guided TKA. J Arthroplasty. 2014 May;29(5):955-60. doi: 10.1016/j.arth.2013.10.020. Epub 2013 Oct 24.
PubMed 24269069Walker PS, Meere PA, Bell CP. Effects of surgical variables in balancing of total knee replacements using an instrumented tibial trial. Knee. 2014 Jan;21(1):156-61. doi: 10.1016/j.knee.2013.09.002. Epub 2013 Sep 19.
PubMed 24103411
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Sensor Guided Knee Balancing Compared to Standard Balancing Technique in Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT02976428
- Acronym / sponsor ID
- HAGRP01
- Conditions
- Total Knee Arthroplasty
- Keywords
- knee soft tissue balancing, sensor-guided, range of motion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 15 May 2018 (actual)
- Study completion
- 3 Sep 2020 (actual)
- First posted
- 29 Nov 2016 (estimated)
- 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.
To ensure a successful outcome after total knee replacement (TKR) soft tissue balance and proper implant position are very important during the surgical procedure. Soft tissues are structures in the knee including ligaments, muscles, tendons, and menisci that stabilize and cushion the knee joint. Lack of proper soft tissue balance or imprecise implant positioning may result in knee stiffness, pain, instability and limited range of motion (ROM). This may result in implant failure and the need for revision surgery. As part of standard practice orthopedic surgeons use a manual knee balancer device to help guide soft tissue balancing to achieve optimal knee balance. New sensor-assisted technology can provide surgeons with measurable information to help achieve soft tissue balancing, providing surgeons with immediate visual feedback during the surgery. This feedback, transmitted wirelessly by the sensor, gives surgeons electronic information on soft tissue balance and implant position.The purpose of this study is to determine if a sensor guided soft tissue balancing device (Verasense) is more effective at balancing the knee during surgery as compared to standard soft tissue balancing performed with a manual balancer device.
Detailed description
The study is that of a prospective double-blind randomized controlled trial of patients presenting for elective primary TKR to compare the outcomes of TKR using conventional soft tissue balancing with a tensiometer device versus augmenting the soft tissue balancing with the OrthoSensor VerasenseTM sensor device. The primary outcome will be rate of unbalanced TKRs based on the quantitative Verasense definition of a well balanced knee defined as a mediolateral intercompartmental loading difference of ≤15 pounds through ROM. Secondary outcomes include differences in clinical outcome scores and patient satisfaction among sensor guided cases and controls.
Patients will be randomized to receive TKR with the Triathlon total knee system (Stryker) in the case and control group according to: (1) control group with standard balancing techniques used and sensor data obtained in blinded fashion and not used to balance the TKR implant, (2) experimental case group with sensor guided balancing where sensor data is used to balance the TKR within defined parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Soft Tissue Balancing | Active comparator | Procedure: Standard Soft Tissue BalancingIn the control group where the sensor device is not used in optimization of knee balance and alignment, definitive implants will be cemented in place and the sensor trial inserted using a thickness based on prior standard bearing insert trialing. Peak load data will be captured intraoperatively through full ROM. Custom shims will be affixed to the sensor to replicate thickness of the standard trial. The knee will then be cycled and loads recorded in the medial and lateral compartments at 10, 45 and 90 degrees of flexion. The surgeon will be blinded to the sensor output and the system will be located outside of their visual field. |
| Sensor Guided Soft Tissue Balancing | Experimental | Procedure: Sensor Guided Soft Tissue BalancingIn the experimental group where the sensor device is used to optimize balance and alignment, the sensor trial will be inserted and tibial baseplate rotated until medial and lateral femoral contact points are parallel on the sensor output. Quantitative balance is defined as a mediolateral intercompartmental loading difference of ≤15 pounds. Flexion balance is achieved when femoral contact point position is within the midposterior third of the tibial insert and intercompartmental loads are balanced. Loads in the medial and lateral compartments are recorded at 10, 45 and 90 degrees. If compartment loads differ by >15 lbs between compartments, unbalanced, further soft tissue release/bone resection will be done to achieve a side to side compartment pressure difference of <15 lbs through ROM. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients scheduled to undergo elective primary unilateral TKR for a diagnosis of osteoarthritis to be performed at the study site by the primary investigators
- Willingness and ability to give informed consent.
Key exclusion criteria (13 listed)
- Inflammatory arthropathy
- Ligament insufficiencies
- Contraindications to posterior cruciate retaining TKR including: deformity >15 degrees or fixed-flexion contracture >15 degrees
- Previous high tibial osteotomy
- Scheduled to undergo sequential bilateral TKR under one anesthetic
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 |
|---|---|---|
| Sensor Guided Soft Tissue BalancingAlso: Triathlon (Stryker, Mahwah, NJ), Verasense (OrthoSensor Inc., Dania Beach, FL)Primary TKR with soft tissue balancing with a sensor guided device. | Procedure or surgery | Sensor Guided Soft Tissue Balancing |
| Standard Soft Tissue BalancingAlso: Triathlon (Stryker, Mahwah, NJ)Primary TKR with soft tissue balancing with a standard of care manual tensiometer device. | Procedure or surgery | Standard Soft Tissue Balancing |
Primary outcome
Rate of Unbalanced TKRs
Time frame: Intraoperative at end of procedure prior to wound closure
The rate of unbalanced TKRs will be assessed based on the Verasense sensor device quantitative definition of a well balanced knee. A well balanced knee is defined as having a mediolateral intercompartmental loading difference of ≤15 pounds through ROM [Gustke et al., Walker et al].
8 secondary outcomes
Knee Society Score
Time frame: Preoperative, 6 weeks, 6 months and 1 year postoperative
Oxford Knee Score
Time frame: Preoperative, 6 weeks, 6 months and 1 year postoperative
Patient satisfaction
Time frame: 1 year postoperative
Clinical knee function: varus/valgus alignment
Time frame: Preoperative, intraoperative, 6 weeks, 6 months and 1 year postoperative
Clinical knee function: anteroposterior stability
Time frame: Preoperative, intraoperative, 6 weeks, 6 months and 1 year postoperative
Clinical knee function: extension lag
Time frame: Preoperative, intraoperative, 6 weeks, 6 months and 1 year postoperative
Clinical knee function: anatomic alignment
Time frame: Preoperative, intraoperative, 6 weeks, 6 months and 1 year postoperative
Clinical knee function: knee ROM
Time frame: Preoperative, intraoperative, 6 weeks, 6 months and 1 year postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2022.
- Background: PubMed 24269069Gustke KA, Golladay GJ, Roche MW, Elson LC, Anderson CR. A new method for defining balance: promising short-term clinical outcomes of sensor-guided TKA. J Arthroplasty. 2014 May;29(5):955-60. doi: 10.1016/j.arth.2013.10.020. Epub 2013 Oct 24.
- Background: PubMed 24103411Walker PS, Meere PA, Bell CP. Effects of surgical variables in balancing of total knee replacements using an instrumented tibial trial. Knee. 2014 Jan;21(1):156-61. doi: 10.1016/j.knee.2013.09.002. Epub 2013 Sep 19.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Mitch Winemaker, MD, FRCSC principal investigator
Hamilton Health Sciences Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sensor Guided Soft Tissue Balancing and Standard Soft Tissue Balancing in people with Total Knee Arthroplasty, run by Hamilton Health Sciences Corporation 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 2 inclusion and 13 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: finished, as of the sponsor's last update on 1 Sep 2022. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Unbalanced TKRs (time frame: Intraoperative at end of procedure prior to wound closure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02976428, which also lists 2 linked publications.
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 1 Sep 2022.