To Determine the Gait and Functional Improvement in Total Knee Arthroplasty

Degenerative Arthritis Clinical Trial

— Orthosensor  

Official title:

A PILOT STUDY: To Determine the Gait and Functional Improvement in Total Knee Arthroplasty With Use of Orthosensor™ VERASENSE™ Knee System for Soft Tissue Balancing.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04057885
• Other study ID #: Orthosensor 101
• Status: Withdrawn
• Phase: N/A
• Start date: May 15, 2017
• Est. completion date: July 31, 2018

Study information

• Verified date: August 2019
• Source: LifeBridge Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 31, 2018
• Est. primary completion date: July 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Degenerative Arthritis
• Osteoarthritis

Intervention

Device:
• Orthosensor™ VERASENSE™ Knee System
A group of patients will receive a total knee arthroplasty using the Orthosensor device

Locations

Country	Name	City	State
United States	Sinai Hospital of Baltimore	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
LifeBridge Health	Orthosensor, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with improvement in gait.		18 months
Primary	Proportion of patients not requiring long term rehabilitation.		18 months
Primary	Proportion of patients with improved function as measured by standardized knee scores.		18 months