Total Knee Arthroplasty
Conditions
Keywords
knee soft tissue balancing, sensor-guided, range of motion
Brief 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. 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.
Interventions
PROCEDUREStandard Soft Tissue Balancing
Primary TKR with soft tissue balancing with a standard of care manual tensiometer device.
PROCEDURESensor Guided Soft Tissue Balancing
Primary TKR with soft tissue balancing with a sensor guided device.
Sponsors
Hamilton Health Sciences Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Unbalanced TKRs | 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 \[Gustke et al., Walker et al\]. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Oxford Knee Score | Preoperative, 6 weeks, 6 months and 1 year postoperative | Subjective function as measured by Oxford Knee Score patient report outcome measure |
| Patient satisfaction | 1 year postoperative | Patient satisfaction with total knee replacement; likert scale |
| Clinical knee function: varus/valgus alignment | Preoperative, intraoperative, 6 weeks, 6 months and 1 year postoperative | Assessment of clinical knee function |
| Knee Society Score | Preoperative, 6 weeks, 6 months and 1 year postoperative | Overall clinical function as measured by Knee Society Score |
| Clinical knee function: extension lag | Preoperative, intraoperative, 6 weeks, 6 months and 1 year postoperative | Assessment of clinical knee function |
| Clinical knee function: anatomic alignment | Preoperative, intraoperative, 6 weeks, 6 months and 1 year postoperative | Assessment of clinical knee function |
| Clinical knee function: knee ROM | Preoperative, intraoperative, 6 weeks, 6 months and 1 year postoperative | Assessment of clinical knee function |
| Clinical knee function: anteroposterior stability | Preoperative, intraoperative, 6 weeks, 6 months and 1 year postoperative | Assessment of clinical knee function |
Countries
Canada
Outcome results
None listed