To Determine the Gait and Functional Improvement in Total Knee Arthroplasty (Orthosensor)

LifeBridge Health

Status: Withdrawn

Conditions: Degenerative Arthritis

Treatments: Device: Orthosensor™ VERASENSE™ Knee System

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04057885

Orthosensor 101

Details and patient eligibility

About

This is an observational study to understand the effects of soft-tissue balancing on gait, function and rehabilitation potential after sensor-assisted Total Knee Arthroplasty

Full description

The primary objectives of this study are to understand the effects of soft-tissue balancing on Gait, function and rehabilitation potential after sensor-assisted Total Knee Arthroplasty and to correlate Intra-operative subjective feel with OrthoSensor Outputs

Secondary objectives are to quantify and observe pain medication use, swelling, muscle strength and girth, gait efficiency, patient satisfaction, activity levels, functional return (i.e., back to work, resume normal activities) and patient perception of a balanced knee

Sex: All

Ages: 45 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Subject must be a candidate for a primary PCL retaining total knee arthroplasty

• Subject must be diagnosed with one or more of the following conditions:

  1. osteoarthritis
  2. avascular necrosis
  3. rheumatoid or other inflammatory arthritis
  4. post-traumatic arthritis Minimum age: 45 Maximum age: 80

• Subject is likely to be available for all study visits

• Subject is able and willing to sign the informed consent and follow study procedures

Exclusion Criteria

1. Prior total knee arthroplasty

2. ligament insufficiencies

3. prior surgeries such as:

   1. ACL or PCL reconstructions
   2. posterolateral reconstructions
   3. osteotomies
   4. tibia plateau fractures
   5. Range of Motion less than 90 degrees f ) flexion contracture of more than 20 degrees

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

Device Arm

Experimental group

Description:

A prospective series of 10 patients will receive sensor-guided TKA using the this special Orthosensor™ VERASENSE™ Knee System assisted surgery for optimization of soft tissue balance

Treatment:

Device: Orthosensor™ VERASENSE™ Knee System

Standard of Care

Active Comparator group

Description:

10 patients will receive standard of care. Prior to cementing final implants, VERASENSE will be utilized with the standard of care group with the surgeon blinded to the data.

Treatment:

Device: Orthosensor™ VERASENSE™ Knee System