Clinical Trial Finder

TKR With and Without the Use of Intra-operative Sensing

Study Purpose

The purpose of this study is to determine if there is a difference in clinical outcomes after total knee replacement (TKR) performed with traditional ligament balancing compared to use of intraoperative sensing technology (IOS) to balance ligaments. IOS is used to send real time information to a monitor within the operating room that assists your surgeon in making decisions about the balance of the ligaments in your knee and the proper insertion of implants. A total of 150 subjects will participate in this study at Hospital for Special Surgery. The hypotheses are that the use of IOS technology will be associated with: 1. Better soft tissue balance during TKR than by manual balancing alone. 2. Higher patient reported clinical outcome measures (PROMs) following surgery.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 40 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Patients who meet the indications for use for primary TKR using IOS.
  • - Subject must be diagnosed with osteoarthritis.
  • - 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:

  • - Revision total knee arthroplasty.
  • - Patient is receiving treatment for any of the following conditions: 1.
Avascular Necrosis. 2. Inflammatory arthritis. 3. Post-traumatic arthritis.
  • - Any knee surgery other than meniscectomy (can be arthroscopic or open) - Ligament insufficiencies, prior surgeries such as anterior cruciate ligament (ACL) or posterior cruciate ligament (PCL) reconstructions, posterolateral reconstructions, osteotomies, tibia plateau fractures.
  • - Ipsilateral foot/ankle and hip arthritis.
  • - Range of motion less than 90° - 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.
  • - Patient out-of-state with medication prescription not registered in iStop database.
  • - Patients with severe contralateral osteoarthritis requiring subsequent knee replacement or with a flexion contracture greater than 10 degrees.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT04251442
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Hospital for Special Surgery, New York
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Alejandro Gonzalez Della Valle, MDKate Shanaghan
Principal Investigator Affiliation Hospital for Special Surgery, New YorkHospital for Special Surgery, New York
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other, Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Osteoarthritis
Additional Details

Participation in this study will involve a knee replacement performed with IOS. Patients will be randomized into one of two groups:The study group will have soft tissue balance performed with the use of IOS. Control group patients will have soft tissue balance performed manually, with final soft tissue balance values measured using IOS, while the surgeon will remain blinded to those values. Intra-operative compartment loads will be measured in 10, 45, and 90 degrees of flexion. Additionally, long leg limb alignment, passive range of motion, use of opioids, daily activity, and PROMS will be evaluated post-operatively to determine which group has better outcomes.

Arms & Interventions

Arms

Experimental: Study Group

The study group will have soft tissue balance performed with the use of IOS.

No Intervention: Control Group

Control group patients will have soft tissue balance performed manually, with final soft tissue balance values measured using IOS, while the surgeon will remain blinded to those values.

Interventions

Device: - OrthoSensor Verasense Technology

IOS is used to send real time information to a monitor within the operating room that assists your surgeon in making decisions about the balance of the ligaments in your knee and the proper insertion of implants.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Hospital for Special Surgery, New York, New York

Status

Recruiting

Address

Hospital for Special Surgery

New York, New York, 10021

Site Contact

Kate Shanaghan

[email protected]

212-774-2490

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