Study Stopped
Lead Investigator no longer with institution
To Determine the Gait and Functional Improvement in Total Knee Arthroplasty
Orthosensor
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.
1 other identifier
interventional
N/A
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started May 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 12, 2015
CompletedStudy Start
First participant enrolled
May 15, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2018
CompletedFirst Posted
Study publicly available on registry
August 15, 2019
CompletedFebruary 26, 2020
August 1, 2019
1.2 years
June 12, 2015
February 24, 2020
Conditions
Outcome Measures
Primary Outcomes (3)
Proportion of patients with improvement in gait.
18 months
Proportion of patients not requiring long term rehabilitation.
18 months
Proportion of patients with improved function as measured by standardized knee scores.
18 months
Study Arms (2)
Device Arm
EXPERIMENTALA 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
ACTIVE COMPARATOR10 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.
Interventions
A group of patients will receive a total knee arthroplasty using the Orthosensor device
Eligibility Criteria
You may qualify if:
- 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:
- osteoarthritis
- avascular necrosis
- rheumatoid or other inflammatory arthritis
- 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
You may not qualify if:
- Prior total knee arthroplasty
- ligament insufficiencies
- prior surgeries such as:
- ACL or PCL reconstructions
- posterolateral reconstructions
- osteotomies
- tibia plateau fractures
- Range of Motion less than 90 degrees f ) flexion contracture of more than 20 degrees
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- LifeBridge Healthlead
- Orthosensor, Inc.collaborator
Study Sites (1)
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael A. Mont, M.D.
Director, Rubin Institute for Advanced Orthopedics and Joint Preservation
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 12, 2015
First Posted
August 15, 2019
Study Start
May 15, 2017
Primary Completion
July 31, 2018
Study Completion
July 31, 2018
Last Updated
February 26, 2020
Record last verified: 2019-08