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

• Sponsor: LifeBridge Health (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT04057885
• Collaborator: Orthosensor, Inc. (Industry)
• Enrollment: 0
• Location: 1
• Arms: 2
• Actual Duration (Months): 14.5
• Patients Per Site Per Month: 0

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Degenerative Arthritis	Device: Orthosensor™ VERASENSE™ Knee System	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• 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.
• Actual Study Start Date: May 15, 2017
• Actual Primary Completion Date: Jul 31, 2018
• Actual Study Completion Date: Jul 31, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Device Arm 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	Device: Orthosensor™ VERASENSE™ Knee System; A group of patients will receive a total knee arthroplasty using the Orthosensor device
Active Comparator: Standard of Care 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.	Device: Orthosensor™ VERASENSE™ Knee System; A group of patients will receive a total knee arthroplasty using the Orthosensor device

Outcome Measures

Primary Outcome Measures

1. Proportion of patients with improvement in gait. [18 months]

2. Proportion of patients not requiring long term rehabilitation. [18 months]

3. Proportion of patients with improved function as measured by standardized knee scores. [18 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 45 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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:

4. ACL or PCL reconstructions

5. posterolateral reconstructions

6. osteotomies

7. tibia plateau fractures

8. Range of Motion less than 90 degrees f ) flexion contracture of more than 20 degrees

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sinai Hospital of Baltimore	Baltimore	Maryland	United States	21215

Sponsors and Collaborators

• LifeBridge Health
• Orthosensor, Inc.

Investigators

• Principal Investigator: Michael A. Mont, M.D., Director, Rubin Institute for Advanced Orthopedics and Joint Preservation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: LifeBridge Health
• ClinicalTrials.gov Identifier: NCT04057885
• Other Study ID Numbers: Orthosensor 101
• First Posted: Aug 15, 2019
• Last Update Posted: Feb 26, 2020
• Last Verified: Aug 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Additional relevant MeSH terms: Osteoarthritis

Study Results

No Results Posted as of Feb 26, 2020