Gait and Functional Improvement in Total Knee Arthroplasty With the Use of Verasense for Soft Tissue Balancing

NCT02290119 | Terminated FDA Device

• 1 other identifier: 101
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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 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)
• Patient perception of a balanced knee

Conditions

Osteoarthritis

Keywords

Primary PCL-retaining Total Knee Arthroplasty; Intraoperative Sensors; Ligament Balancing; Clinical Outcomes

Outcome Measures

Primary Outcomes (1)

• Rehabilitation Potential

  6 Months

Secondary Outcomes (3)

• Knee Society Pain and Functional Scoring (KSS)

  6 month

• Forgotten Joint Score (FJS)

  6 month

• 3D Gait Analysis velocity

  6 Month

Study Arms (2)

Control - Without the use of Verasense

SHAM COMPARATOR

Total Knee Replacement without the use of intraoperative sensors

Procedure: Control - Without the use of Verasense

Sensor-assisted TKR (Verasense)

ACTIVE COMPARATOR

Total Knee Replacement with the use of intraoperative sensors

Device: Sensor-assisted TKR (Verasense)

Interventions

Sensor-assisted TKR (Verasense) DEVICE

Verasense is a single use, disposable device embedded with microelectronics into a standard tibial trial to provide dynamic, intraoperative feedback regarding limb alignment, tibiofemoral position and quantitative pressure at peak contact points in the medial and lateral compartments during total knee replacement surgery. Utilizing sensor-derived data, the surgeon can now evaluate intercompartmental loading throughout the range of motion, and correct for soft-tissue abnormalities while receiving real-time feedback regarding joint balance.

Sensor-assisted TKR (Verasense)

Control - Without the use of Verasense PROCEDURE

Patients in this cohort will undergo manual total knee replacement without the use of Verasense

Control - Without the use of Verasense

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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
• Subject is between the age of 45 - 80 years
• 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, flexion contracture of more than 20 degrees

Sponsors & Collaborators

• Orthosensor, Inc.: lead

Study Sites (1)

Sinai Hospital of Baltimore - Rubin Institute of Advanced Orthopedics Center for Joint Preservation and Reconstruction

Baltimore, Maryland, 21215-5271, United States

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Ron Delanois, MD

  Sinai Hospital of Baltimore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2014
• First Posted: November 13, 2014
• Study Start: April 1, 2018
• Primary Completion: October 12, 2022
• Study Completion: October 12, 2022
• Last Updated: February 6, 2023

Record last verified: 2023-02

Locations

US (1)