Prospective Clinical Study Evaluating Tibiofemoral Rotational Alignment Using Intraoperative Sensing During TKA
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| ClinicalTrials.gov Identifier: NCT02286739 |
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Recruitment Status : Unknown
Verified April 2017 by Orthosensor, Inc..
Recruitment status was: Recruiting
First Posted : November 10, 2014
Last Update Posted : April 5, 2017
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Sponsor:
Orthosensor, Inc.
Information provided by (Responsible Party):
Orthosensor, Inc.
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Brief Summary:
The objectives of the study are twofold: 1) Evaluate how intra-operative sensing may assist the surgeon with tibiofemoral rotational alignment by testing the precision and variability of setting tray rotation to the mid-third of the tibial tubercle. 2) Understand if patients with a combined axial rotation couple at the tibiofemoral joint and quantitative intercompartmental balance, achieved with the use of VERASENSE, exhibit less post-operative knee pain and improved clinical outcomes. Radiographic outcomes will also be assessed to measure post-operative alignment and to evaluate the prevalence and location of radiolucency and/or osteolysis.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Osteoarthritis | Device: TKA with "Verasense" Procedure: TKA without "Verasense" | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 500 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Basic Science |
| Official Title: | Prospective Clinical Study Evaluating Tibiofemoral Rotational Alignment Using Intraoperative Sensing During Total Knee Arthroplasty |
| Study Start Date : | April 2015 |
| Estimated Primary Completion Date : | December 2018 |
| Estimated Study Completion Date : | December 2018 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Osteoarthritis
| Arm | Intervention/treatment |
|---|---|
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Sham Comparator: Group A TKA without VERASENSE
will consist of 250 consecutive patients who will undergo primary PCL-retaining or - sacrificing TKA without the use of VERASENSE to guide rotational alignment and balance.
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Procedure: TKA without "Verasense"
TKA will be performed manually without the use of Verasense |
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Active Comparator: Group B TKA with VERASENSE
will consist of 250 consecutive patients who will undergo primary PCL-retaining or - sacrificing TKA with the use of VERASENSE to guide rotational alignment and balance.
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Device: TKA with "Verasense"
VERASENSE replaces the standard tibial trial inserts and is embedded with microelectronics and sensors to provide surgeons with real-time knee kinetic data. The data is wirelessly transmitted to a graphic display (VERASENSE Knee Application), allowing surgeons to quantify and assess soft tissue intercompartmental loads throughout the range of motion. The VERASENSE sensor is not an investigational device. OrthoSensor, Inc., received FDA 510K clearance in 2009. The indication for use is a tool for adjustment of the femoral knee implant to reduce instability from flexion gap asymmetry. The VERASENSE sensor is sterile and single patient use. |
Primary Outcome Measures :
- Knee Society Pain and Functional Scoring [ Time Frame: Changes from baseline at 24 months ]
Secondary Outcome Measures :
- Anterior Knee Pain Evaluation [ Time Frame: Changes from baseline at 24 months ]
- EQ5D [ Time Frame: Changes from baseline at 24 months ]
- Forgotten Joint Score [ Time Frame: Changes from baseline at 24 months ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Patients who meet the indications for use for Triathlon® Total Knee System using VERASENSE™
- Subject must be diagnosed with one or more of the following conditions
- osteoarthritis
- rheumatoid or other inflammatory arthritis
- post-traumatic arthritis
- 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:
- Prior Total Knee Arthroplasty
- Avascular Necrosis
- Any knee surgery other than meniscectomy (can be arthroscopic or open)
- Ligament insufficiencies, prior surgeries such as ACL or PCL reconstructions, posterolateral reconstructions, osteotomies, tibia plateau fractures
- Ipsilateral foot/ankle and hip arthritis
- Range of motion less than 90°, flexion contracture greater than 20°
- Subject has a mental condition that may interfere with the subject's ability to give an informed consent or willingness to fulfill the study requirements (i.e., severe mental retardation such that the Subject cannot understand the informed consent process, global dementia, prior strokes that interfere with the Subject's cognitive abilities, senile dementia, and Alzheimer's Disease)
- Any subjects meeting any contraindication criteria as identified in the locally approved labeling for the device should be excluded from this study.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02286739
Contacts
| Contact: Christopher R. Anderson, MS, MBA | (954) 372-2641 | canderson@orthosensor.com | |
| Contact: Leah C. Elson, BS | 954-577-7770 | lelson@orthosensor.com |
Locations
| United States, Florida | |
| The Cleveland Clinic Foundation | Recruiting |
| Weston, Florida, United States | |
| Contact: Cecilia Calvo calvoc@ccf.org | |
| Principal Investigator: Preetesh Patel, MD | |
| United States, Georgia | |
| Emory University | Recruiting |
| Atlanta, Georgia, United States, 30329 | |
| Contact: Jared O'Neal jwoneal@emory.edu | |
| Principal Investigator: Thomas Bradbury, MD | |
| United States, Illinois | |
| Illinois Bone & Joint Institute | Recruiting |
| Morton Grove, Illinois, United States, 60053 | |
| Contact: Nancy R Cipparrone ncipparrone@ibji.com | |
| Principal Investigator: Alexander Gordon, MD | |
| United States, New York | |
| NYU Hospital for Joint Diseases | Recruiting |
| New York, New York, United States, 10003 | |
| Contact: Ariel Aponte, CCRC ariel.aponte@nyumc.org | |
| Principal Investigator: Ivan Fernandez-Madrid, MD | |
| United States, Ohio | |
| The Cleveland Clinic Foundation | Recruiting |
| Cleveland, Ohio, United States, 44195 | |
| Contact: Gannon Curtis, MD curtisg@ccf.org | |
| Principal Investigator: Wael Barsoum, MD | |
| United States, Virginia | |
| Virginia Commonwealth University | Recruiting |
| Richmond, Virginia, United States | |
| Contact: Megan Hansen mhansen@mcvh-vcu.edu | |
| Principal Investigator: Gregory Golladay, MD | |
Sponsors and Collaborators
Orthosensor, Inc.
| Responsible Party: | Orthosensor, Inc. |
| ClinicalTrials.gov Identifier: | NCT02286739 |
| Other Study ID Numbers: |
102 |
| First Posted: | November 10, 2014 Key Record Dates |
| Last Update Posted: | April 5, 2017 |
| Last Verified: | April 2017 |
Keywords provided by Orthosensor, Inc.:
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Total Knee Arthroplasty Rotational Alignment Intraoperative Sensors Patient Outcomes Soft Tissue Balance |
Additional relevant MeSH terms:
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Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases |