Track topics on Twitter Track topics that are important to you
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.
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.
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Total Knee Arthroplasty
Sensor Guided Soft Tissue Balancing, Standard Soft Tissue Balancing
Not yet recruiting
Hamilton Health Sciences Corporation
Published on BioPortfolio: 2016-11-30T15:45:29-0500
The purpose of this study is to compare the patient reported outcome measures of total knee replacement patients who received intra operative sensor guided technique for soft tissue balanc...
The goal of this project is to evaluate the safety and preliminary efficacy of ExAblate MR guided focused ultrasound surgery in the treatment of soft tissue tumors of the extremities.
The objective of this study is to evaluate the safety and hemostatic effectiveness of the Fibrin Pad (FP) versus standard of care treatment (SoC) in controlling challenging severe soft tis...
This study evaluates the impact of soft tissue grafts on soft tissue recession following immediate implant, provisional and bone graft placement in compromised sockets. One third of the pa...
Translational studies in cancer research can be impeded by the lack of high-quality clinical data that can be correlated with research questions. This is particularly true in the case of r...
Balancing techniques in total knee arthroplasty are often based on surgeons' subjective judgment. However, newer technologies have allowed for objective measurements of soft tissue balancing. This stu...
To evaluate the pain-alleviating effect of computed tomography (CT)-guided percutaneous cryoablation for recurrent retroperitoneal soft-tissue sarcomas (RPSs).
Melorheostosis is a very rare disorder characterized by irregular cortical thickening seen on radiographs. In this paper, we present a case of melorheostosis with microscopically confirmed soft-tissue...
Primary lymphoma of bone and soft tissue is rare and almost invariably of B-cell origin. Osseous lymphoma usually reveals aggressive bone destruction and associated soft tissue extension. Soft tissue ...
Soft tissue infections are a common reason for general surgical consultation. Necrotizing soft tissue infections (NSTI) are a rapidly progressive form of this infection that account for significant mo...
Injuries of tissue other than bone. The concept is usually general and does not customarily refer to internal organs or viscera. It is meaningful with reference to regions or organs where soft tissue (muscle, fat, skin) should be differentiated from bones or bone tissue, as "soft tissue injuries of the hand".
Infections of non-skeletal tissue, i.e., exclusive of bone, ligaments, cartilage, and fibrous tissue. The concept is usually referred to as skin and soft tissue infections and usually subcutaneous and muscle tissue are involved. The predisposing factors in anaerobic infections are trauma, ischemia, and surgery. The organisms often derive from the fecal or oral flora, particularly in wounds associated with intestinal surgery, decubitus ulcer, and human bites. (From Cecil Textbook of Medicine, 19th ed, p1688)
Neoplasms developing from some structure of the connective and subcutaneous tissue. The concept does not refer to neoplasms located in connective or soft tissue.
A sarcoma containing large spindle cells of smooth muscle. Although it rarely occurs in soft tissue, it is common in the viscera. It is the most common soft tissue sarcoma of the gastrointestinal tract and uterus. The median age of patients is 60 years. (From Dorland, 27th ed; Holland et al., Cancer Medicine, 3d ed, p1865)
Implants used in arthroscopic surgery and other orthopedic procedures to attach soft tissue to bone. One end of a suture is tied to soft tissue and the other end to the implant. The anchors are made of a variety of materials including titanium, stainless steel, or absorbable polymers.