Using Intraoperative Sensing Technology to Evaluate Revision Total Knee Arthroplasty

NCT03023410 | Terminated Results

• 1 other identifier: Revision TKA Study
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

This study will attempt to draw relationships between the soft-tissue related complications contributing to early TKA revision and the loading and positional patterns from intraoperative tibial trial sensors. The data from the sensors may enable the surgeon to address such soft-tissue abnormalities that may otherwise be unknown during traditional total knee revision procedures. The utilization of sensors should in theory, help diagnose the potential causes attributing to soft-tissue imbalance and may lead to a decreased need for an all component revision. Furthermore, the economic implications from converting a total revision to a partial revision could have a profound effect to the patient and healthcare provider such as decreased rehabilitation regimes and opportunity for cost savings. Eligible revision patients who agree to participate will be followed for a period of 12 months following the revision procedure. Patient reported outcomes measures (PROM) such as the 2011 Knee Society Score (KSS) and the Veterans Rand 12-Item Health Survey (VR-12) will be collected at baseline (pre-operatively) and at 6 weeks, 6 months and 12 months post-procedure. All outcomes will be scored to observe changes from baseline at 12-months. Cost-analyses of sensor-assisted revision TKA will be performed to include OR costs, facility and physician fees, as well as payments to post-acute collaborators such as SNFs, rehab hospitals, PT and home care providers. A quantitative analysis of commercial payer claims / usage data (e.g., CMS Medpar data) will be used to examine costs associated with traditional revision TKA procedures.

Conditions

Knee Osteoarthritis

Keywords

Revision TKA; Instability; Stiffness; Aseptic Loosening; Polyethylene Wear; Malrotation; Soft Tissue Imbalance

Outcome Measures

Primary Outcomes (1)

• Cause of Early TKA Revision

  The objective is to evaluate and link the possible causes of early TKA revision procedures using intraoperative sensors in effort to understand why knees fail in addition to examining the economic implications to the patient and hospital.

  12-months

Secondary Outcomes (2)

• Knee Society Score

  12 months

• Veterans Rand 12-Item Health Survey

  Change from Baseline at 12-months

Study Arms (2)

Partial Revision

A "partial" revision will be indicated when only the tibial liner is changed or only the tibial liner with the tibial tray or only the tibial liner with the femoral component.

Procedure: VERASENSE

Total Revision

A "total" revision will be indicated when all components are completely removed and replaced (tibial tray, femoral component and tibial liner).

Procedure: VERASENSE

Interventions

VERASENSE PROCEDURE

Sensor-Assisted Revision TKA

Also known as: Sensor-Assisted TKA

Partial Revision; Total Revision

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who are candidates for revision TKA and meet all inclusion and no exclusion will be offered study participation without regard to race, sex, economic status, or religious belief.

You may qualify if:

• Patients undergoing revision unilateral total knee arthroplasty within the first 5-years of the index procedure
• Include Male and Female subjects
• Include subjects 18 years and older
• Patients should present with idiopathic pain and/or instability/stiffness attributed to aseptic loosening, polyethylene wear or malrotation
• Patients able to understand study intent, and agree to study participation
• Patients must be previously implanted with the following cruciate-retaining (CR) or posterior-substituting (PS) total knee systems: Stryker TRIATHLON, Zimmer-Biomet VANGUARD or NEXGEN or Smith and Nephew LEGION or JOURNEY II.

You may not qualify if:

• No prior revision surgery on operative side
• Ligament insufficiencies, prior surgeries such as PCL reconstructions, posterolateral reconstructions, osteotomies, tibia plateau fractures
• Culture positive aspiration indicating infection of the joint
• ASA class \> III
• History of drug or alcohol abuse

Sponsors & Collaborators

• Orthosensor, Inc.: lead

Study Sites (1)

Holy Cross Hospital, Orthopedic Institute

Fort Lauderdale, Florida, 33334, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Volvulus Of Midgut

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Results Point of Contact

• Title: Kevin Barga
• Organization: Stryker

Kevin.Barga@stryker.com

+12018315073

Study Officials

• William Leone, MD

  Holy Cross Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2017
• First Posted: January 18, 2017
• Study Start: January 17, 2018
• Primary Completion: July 16, 2018
• Study Completion: July 16, 2018
• Last Updated: January 29, 2025
• Results First Posted: January 29, 2025

Record last verified: 2024-06

Locations

US (1)