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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02976428
Other study ID # HAGRP01
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 1, 2017
Est. completion date September 3, 2020

Study information

Verified date August 2022
Source Hamilton Health Sciences Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 184
Est. completion date September 3, 2020
Est. primary completion date May 15, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Sensor Guided Soft Tissue Balancing
Primary TKR with soft tissue balancing with a sensor guided device.
Standard Soft Tissue Balancing
Primary TKR with soft tissue balancing with a standard of care manual tensiometer device.

Locations

Country Name City State
Canada Hamilton Health Sciences Juravinski Hospital Hamilton Ontario

Sponsors (1)

Lead Sponsor Collaborator
Hamilton Health Sciences Corporation

Country where clinical trial is conducted

Canada, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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]. Intraoperative at end of procedure prior to wound closure
Secondary Knee Society Score Overall clinical function as measured by Knee Society Score Preoperative, 6 weeks, 6 months and 1 year postoperative
Secondary Oxford Knee Score Subjective function as measured by Oxford Knee Score patient report outcome measure Preoperative, 6 weeks, 6 months and 1 year postoperative
Secondary Patient satisfaction Patient satisfaction with total knee replacement; likert scale 1 year postoperative
Secondary Clinical knee function: varus/valgus alignment Assessment of clinical knee function Preoperative, intraoperative, 6 weeks, 6 months and 1 year postoperative
Secondary Clinical knee function: anteroposterior stability Assessment of clinical knee function Preoperative, intraoperative, 6 weeks, 6 months and 1 year postoperative
Secondary Clinical knee function: extension lag Assessment of clinical knee function Preoperative, intraoperative, 6 weeks, 6 months and 1 year postoperative
Secondary Clinical knee function: anatomic alignment Assessment of clinical knee function Preoperative, intraoperative, 6 weeks, 6 months and 1 year postoperative
Secondary Clinical knee function: knee ROM Assessment of clinical knee function Preoperative, intraoperative, 6 weeks, 6 months and 1 year postoperative
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