Conventional vs. Sensor Guided Soft Tissue Balancing in TKA RCT

Total Knee Arthroplasty Clinical Trial

Official title:

Randomized Controlled Trial of Sensor Guided Knee Balancing Compared to Standard Balancing Technique in Total Knee Arthroplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02976428
• Other study ID #: HAGRP01
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Total Knee Arthroplasty

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