CLINICAL TRIAL

CORI Robotics for Replacement

Recruiting · 18+ · All Sexes · New Albany, OH

Study to Evaluate the Safety and Effectiveness of REAL INTELLIGENCE™ CORI™ in Knee Arthroplasty Procedures

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About the trial for Replacement

Eligible Conditions
Replacement · Arthroplasty · Knee

Treatment Groups

This trial involves 2 different treatments. CORI Robotics is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
CORI Robotics
DEVICE
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

Eligibility

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
The subject requires a cemented knee replacement as a primary indication, which meets either criterion A or B. show original
The subject agrees to participate in the study and agrees to follow the study visit schedule as defined in the study protocol and informed consent form show original
The clinician has decided that a Smith+Nephew knee implant system is the best treatment for the subject's knee surgery, and the subject has agreed to the treatment. show original
Correction of functional deformity is required. show original
The text requires that fractures that cannot be treated using other techniques be managed with this technique. show original
Degenerative joint disease, including osteoarthritis
Rheumatoid arthritis
The subject is considered skeletally mature and is of legal age to consent to surgery. show original
, is the most common form of arthritis show original
Avascular necrosis
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 6 week, 6 month and 12 months
Screening: ~3 weeks
Treatment: Varies
Reporting: 6 week, 6 month and 12 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 6 week, 6 month and 12 months.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether CORI Robotics will improve 1 primary outcome and 12 secondary outcomes in patients with Replacement. Measurement will happen over the course of 6 weeks.

Component Alignment - TKA
6 WEEKS
Component alignment will be assessed on long leg standing antero-posterior (A/P) X-rays and standard non weight bearing lateral X-rays taken 6 weeks after surgery in TKA subjects
6 WEEKS
Component Alignment - UKA
6 WEEKS
Component alignment will be assessed on long leg standing antero-posterior (A/P) X-rays and standard non weight bearing lateral X-rays taken 6 weeks after surgery in UKA subjects.
6 WEEKS
Post-operative leg alignment
6 WEEKS
Post-operative leg alignment via radiographic assessment. Post-operative leg alignment is achieved when the deviation from the subject specific target does not exceed ±3 degrees.
6 WEEKS
Radiographic assessment - TKA
12 MONTHS
Radiographic assessment on antero-posterior (A/P) and lateral (L) views shall be performed to identify the presence of radiolucent lines, osteolysis & implant migration in TKA subjects
12 MONTHS
Radiographic assessment - UKA
12 MONTHS
Radiographic assessment on antero-posterior (A/P) and lateral (L) views shall be performed to identify the presence of radiolucent lines, osteolysis & implant migration in UKA subjects
12 MONTHS
Oxford Knee Score (OKS) - UKA
PRE-OP, 6 WEEK, 6 MONTH AND 12 MONTHS
To specifically assess the patient's perspective of outcome following knee arthroplasty surgery in UKA subjects. Responses to each question ranges from 0-4 with a range of a possible overall score from 0-48. A score of 0 is the worst possible outcome while a score of 48 is the best possible outcome.
PRE-OP, 6 WEEK, 6 MONTH AND 12 MONTHS
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Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people get arthroplasty a year in the United States?

Arthroplasty is commonly performed in the United States. The American Medical Association Council on the Practice of Medicine says more than 700,000 procedures on more than 3 million people are performed annually.\n

Anonymous Patient Answer

What are the signs of arthroplasty?

The clinical course of an arthroplasty is characterized by the presence of fever in the recovery period (postoperative period), and pain during the first twenty-four hours after hospitalization. Signs of pain in the early recovery days include intense pain that cannot be controlled, and is associated with nausea and vomiting. To confirm the diagnosis of arthroplasty, the pain must be alleviated by administering narcotic medication (preferably continuous). If there is not pain relief during the recovery period, the patient needs a revision of the procedure, followed by a surgical removal of the faulty prosthesis. There are other conditions that mimic arthritis, but the physical exam typically involves joint inspection, palpation, and range of motion exam of the affected joint.

Anonymous Patient Answer

What is arthroplasty?

The terms 'arthroplasty' and 'arthrossist' are used regularly in the general public and medical literature but are less common in standard encyclopedic texts on orthopaedic surgery. The term 'arthrothroseer' is more commonly used, but this is not the term preferred for use in non-medical orthopaedic text.

Anonymous Patient Answer

What are common treatments for arthroplasty?

Arthroplasty with autograft is most common with a very low risk of complications. It is considered the standard of care and it is expected to be the treatment of choice once clinical evidence is established.

Anonymous Patient Answer

Can arthroplasty be cured?

Results from a recent paper has shown that arthroplasty is effective in managing end-stage disease for a specific group of patients, and has not led to a cure for OA.

Anonymous Patient Answer

What causes arthroplasty?

When compared with their non-operated knee, people who undergo arthroplasty have lower functional ability and an increased risk of a revision over the short and intermediate terms. The cause of revision in arthroplasty cases is unrelated to other factors associated with implant failure such as infection and prosthesis loosening or wear.

Anonymous Patient Answer

How does cori robotics work?

Cori Technology Corp has developed a product that can predictably and accurately replace an intra-articular total hip joint. The Cori approach uses [Magnetics] (https://www.youtube.com/watch?v=u_6uB0Zv0sE) to create a magnetic field around the prosthesis and [Electro] (https://www.cori-tech.com/about-cori-technologies-group/about-cori-technology/cori-robotics) is used to move the prosthesis towards its desired position by creating small electromagnetic fields. These electromagnetic fields are set in direct parallel with one another in a helispheric fashion.

Anonymous Patient Answer

What are the latest developments in cori robotics for therapeutic use?

Although cori arthroplasties do not replace primary total knee arthroplasties, cori arthroplasties are becoming increasingly popular alternatives for the surgical management of degenerative joint disease.

Anonymous Patient Answer

Is cori robotics safe for people?

Results from a recent paper and our own clinical experience, cori has undergone good results in terms of durability and clinical outcomes of arthroplasty in people. Its use is associated with a low risk of complications and, therefore, offers the potential for long-term cost-effective treatment of painful hips. Further prospective study is needed to explore the long-term result of cori arthroplasty.

Anonymous Patient Answer

What are the common side effects of cori robotics?

It was evident that the most common side effects of cori in this study were swelling and pain. We were able to predict pain as an incidence of pain in coris, as we see in other procedures as well. It is advisable to inform the patients before the operation. We may consider using a more conservative method to avoid complications and provide a better post-operative outcome in order to achieve better functional recovery. For patients who would like to have an ambulatory rehabilitation programme, they may undergo a hip fracture surgery in this field with the use of cori.

Anonymous Patient Answer

How serious can arthroplasty be?

Although this procedure can usually be carried out safely, there is still a risks of infection and bleeding due to the prolonged duration of the operation and the proximity of the bone and the joint surface. If you are not sure how serious a risk the procedure will be for your loved one, get your doctor to check it out (https://arthroplasty.med.umich.edu/patient/management/surgery/operating/arth.html). If you'd like to join a clinical trial, go to Power (www.withpower.com).

Anonymous Patient Answer

Who should consider clinical trials for arthroplasty?

Given the significant number of orthopaedic surgeons who have reported being approached by patients who wish to be evaluated for participation in the clinical trial, we feel that there is a need for additional resources to help them properly evaluate their patients' suitability before participating in such trials.

Anonymous Patient Answer
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