To Determine the Gait and Functional Improvement in Total Knee Arthroplasty

Not Applicable

Withdrawn

• Conditions: Degenerative Arthritis
• Interventions: Device: Orthosensor™ VERASENSE™ Knee System

• Registration Number: NCT04057885
• Lead Sponsor: LifeBridge Health

Brief Summary

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

Detailed 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

Study Timeline

• Study First Submitted: 2015-06-12
• Study Start: 2017-05-15
• Primary Completion: 2018-07-31
• Study Completion: 2018-07-31
• Status Verified: 2019-08
• Study First Submitted QC: 2019-08-14
• Study First Posted: 2019-08-15
• Last Update Submitted: 2020-02-24
• Last Update Posted: 2020-02-26

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Device Arm	Orthosensor™ VERASENSE™ Knee System	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
Standard of Care	Orthosensor™ VERASENSE™ Knee System	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.

Primary Outcome Measures

Name	Time	Method
Proportion of patients with improved function as measured by standardized knee scores.	18 months
Proportion of patients with improvement in gait.	18 months
Proportion of patients not requiring long term rehabilitation.	18 months

Trial Locations

Locations (1)

Sinai Hospital of Baltimore; 🇺🇸 Baltimore, Maryland, United States