Clinical trial NCT02976428: Conventional vs. Sensor Guided Soft Tissue Balancing in TKA RCT
Official title: Randomized Controlled Trial of Sensor Guided Knee Balancing Compared to Standard Balancing Technique in Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Total Knee Arthroplasty
Keywords: knee soft tissue balancing
sensor-guided
range of motion
Lead sponsor: Hamilton Health Sciences Corporation
Sponsor class: OTHER
First posted: 2016-11-29
Enrollment: 184
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of Unbalanced TKRs
timeFrame: Intraoperative at end of procedure prior to wound closure
Secondary outcomes:
measure: Knee Society Score
timeFrame: Preoperative, 6 weeks, 6 months and 1 year postoperative
measure: Oxford Knee Score
timeFrame: Preoperative, 6 weeks, 6 months and 1 year postoperative
measure: Patient satisfaction
timeFrame: 1 year postoperative
measure: Clinical knee function: varus/valgus alignment
timeFrame: Preoperative, intraoperative, 6 weeks, 6 months and 1 year postoperative
measure: Clinical knee function: anteroposterior stability
timeFrame: Preoperative, intraoperative, 6 weeks, 6 months and 1 year postoperative
measure: Clinical knee function: extension lag
timeFrame: Preoperative, intraoperative, 6 weeks, 6 months and 1 year postoperative
measure: Clinical knee function: anatomic alignment
timeFrame: Preoperative, intraoperative, 6 weeks, 6 months and 1 year postoperative
measure: Clinical knee function: knee ROM
timeFrame: Preoperative, intraoperative, 6 weeks, 6 months and 1 year postoperative
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Hamilton Health Sciences Juravinski Hospital
state: Ontario
Study officials:
affiliation: Hamilton Health Sciences Corporation
name: Mitch Winemaker, MD, FRCSC
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Walker 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.