CORI™ Knee Tensioner for Knee Replacement Surgery

Not currently recruiting at 4 trial locations

Overseen By Leann Speering, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Smith & Nephew, Inc.

Disqualifiers: Pregnancy, Non-English speaking, Obesity, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of a new knee surgery tool, the CORI™ KNEE TENSIONER, in conjunction with the CORI™ Surgical System, a robotic knee replacement system. The goal is to determine if this tool enhances the surgery experience and outcomes for patients requiring knee replacements. Suitable candidates have knee issues such as osteoarthritis or rheumatoid arthritis and require a knee replacement with a cemented total knee arthroplasty (TKA). As an unphased trial, this study provides patients the chance to contribute to innovative surgical advancements and potentially enhance their knee replacement experience.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What prior data suggests that the CORI™ Knee Tensioner is safe for knee replacement surgery?

Research has shown that the CORI™ Surgical System, which includes the CORI™ Knee Tensioner, enhances precision in knee surgeries. Studies have found that the CORI system aids in planning and performing these surgeries by assisting with bone preparation and implant placement. This design, including the Tensioner, ensures safety by enabling more accurate operations.

The CORI™ Knee Tensioner helps doctors assess knee joint tightness before making cuts, ensuring a good fit for knee replacements and reducing potential complications. Although specific safety data for the Knee Tensioner alone is unavailable, the CORI Surgical System's established use in surgeries supports its overall safety.

In summary, the CORI™ Knee Tensioner is part of a system that improves surgical precision, suggesting general safety. However, like any medical device, it may carry risks, so discussing these with a healthcare team is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The CORI™ Knee Tensioner is unique because it integrates with a robotic surgical system to optimize knee tension during total knee replacement surgery. Unlike traditional methods that rely on manual adjustments, this tensioner provides consistent and precise tensioning, potentially leading to improved outcomes and faster recovery. Researchers are excited about this treatment as it leverages advanced robotics to enhance surgical precision, aiming to improve patient satisfaction and joint function post-surgery.

What evidence suggests that the CORI™ Knee Tensioner is effective for knee replacement surgery?

Research has shown that the CORI™ KNEE TENSIONER, when used with the CORI Surgical System, aids surgeons by providing consistent measurements of knee joint movement. This ensures correct knee movement during surgery. Studies suggest that this tool enhances surgical precision, crucial for successful knee replacements. The device automatically collects data, aiding in surgical planning and improving outcomes. Overall, these features aim to enhance the effectiveness of knee surgeries, potentially leading to better recovery and movement for patients. ^{1 2 3 4 5}

Who Is on the Research Team?

Kelli Armstrong

Principal Investigator

Smith & Nephew, Inc.

Are You a Good Fit for This Trial?

This trial is for adults over 18 who need a knee replacement due to conditions like osteoarthritis or rheumatoid arthritis and can follow up for one year. They must understand English, not be morbidly obese (BMI under 40), and have no active infections, severe joint diseases, or mental illness affecting compliance.

Inclusion Criteria

Subject agrees to consent to the study by signing the Independent Review Board (IRB) approved ICF

Subject is suitable for the CORI™ Surgical System

I need a knee replacement due to arthritis, bone death, deformity, or unmanageable fractures.

Exclusion Criteria

Participation in the treatment period of another clinical trial within thirty (30) days of the Pre-Operative Visit, or during the study

I am not pregnant, nursing, or if capable of becoming pregnant, I am using birth control.

I do not have an active infection or sepsis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative

Pre-operative assessments including collection of baseline data and measurements

1 week

1 visit (in-person)

Surgical Procedure

Robotic-assisted TKA procedure with the CORI Surgical System and CORI™ KNEE TENSIONER

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

4 visits (in-person) at 6 weeks, 6 months, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• REAL INTELLIGENCE Tensioner

Trial Overview The CORI™ KNEE TENSIONER's performance is being tested as an accessory to the CORI™ Surgical System during knee replacement surgeries. The study aims to assess how well it works with the surgical system in improving surgery outcomes.

How Is the Trial Designed?

Group I: CORI TENSIONER Experimental Treatment 1 Intervention

Subjects having a robotic TKA procedure with the CORI Surgical System, including the use of the CORI™ KNEE TENSIONER accessory.

Who Is Running the Clinical Trial?

Smith & Nephew, Inc.

Lead Sponsor

Trials

176

Recruited

23,500+

Dr. Maria Berkman

Smith & Nephew, Inc.

Chief Medical Officer since 2023

MD from Harvard Medical School

Dr. Deepak Nath

Smith & Nephew, Inc.

Chief Executive Officer since 2022

PhD in Theoretical Mechanics, University of California, Berkeley

Published Research Related to This Trial

Robotic-arm assisted total knee arthroplasty (RA-TKA) resulted in the least intraoperative bleeding compared to patient-specific instrumentation (PSI-TKA) and conventional TKA (COTKA), indicating a more minimally invasive approach.

While RA-TKA had a longer operation time, it achieved better alignment in the sagittal tibial component angle compared to PSI-TKA and COTKA, suggesting improved accuracy in surgical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Semiactive robotic-arm system versus patient-specific instrumentation in primary total knee arthroplasty: Efficacy and accuracy. He, R., Sun, M., Xiong, R., et al.[2023]

In a study involving 22 cadaver knees, both visual and blinded methods of measuring extension and flexion gaps during total knee arthroplasty resulted in oversized and asymmetric gaps compared to measurements taken with a controlled tensioner.

The visual method produced slightly less oversizing and asymmetry than the blinded method, but both methods were significantly different from the tensioner measurements, indicating that manual spreader assessments may not be reliable for accurate gap evaluation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is the Use of Spreaders an Accurate Method for Ligament Balancing? Ferreira, MC., Franciozi, CES., Kubota, MS., et al.[2018]

In a study of 23 patients undergoing total knee arthroplasty (TKA) using Zimmer Patient Specific Instruments (PSIs), the average Knee Society Score was 85.5, indicating good clinical outcomes one year post-surgery, with a high satisfaction rate of 94%.

Radiographic assessments showed optimal knee alignment in 18 patients, and no signs of implant loosening were recorded, suggesting that PSIs can effectively enhance surgical precision and outcomes, especially in patients with anatomical challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Use of Patient Specific Instruments at Total Knee Arthroplasty. One-Year Results of a Prospective Randomised Study]. Musil, D., Stehlík, J., Abrman, K., et al.[2017]

Computer-aided surgery has been shown to improve the accuracy of leg axis reconstruction in total knee replacements, but outliers still occur due to the significant impact of soft tissue management on postoperative stability.

The study highlights the importance of the anatomical approach and patellar positioning in managing soft tissue tension, particularly in cases of severe leg axis deformities, which can aid surgeons in achieving better outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Advances in soft tissue management in total knee arthroplasty. The use of imageless navigation systems]. Lüring, C., Perlick, L., Tingart, M., et al.[2018]

In a study of 5,486 primary total knee arthroplasties (TKAs) using image-derived instrumentation (IDI), there was no significant difference in the overall revision rates at 5 years compared to computer-navigated and other standard methods, with revision rates of 3.3% for IDI, 2.4% for computer navigation, and 2.5% for other methods.

However, the IDI method was associated with higher revision rates in specific cases, particularly for posterior-stabilized TKAs and in patients aged 65 and younger, indicating that while IDI may not be worse overall, it should be used cautiously in these subgroups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Image-Derived Instrumentation on Total Knee Arthroplasty Revision Rates: An Analysis of 83,823 Procedures from the Australian Orthopaedic Association National Joint Replacement Registry. McAuliffe, MJ., Beer, BR., Hatch, JJ., et al.[2019]

The use of a novel ligament tensioning device in total knee arthroplasty (TKA) significantly reduced the manipulation rate from 16% with traditional methods to 7% when combined with computer-assisted navigation, indicating improved surgical outcomes.

Radiographic alignment data showed that all TKAs performed with the tensioning device were within 4 degrees of the desired position, demonstrating enhanced accuracy in knee alignment post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ligament balancing in computer-assisted total knee arthroplasty: improved clinical results with a spring-loaded tensioning device. Swank, M., Romanowski, JR., Korbee, LL., et al.[2017]

Patient-specific instrumentation (PSI) technology for knee replacement surgery allows for more precise planning and execution, leading to reduced surgical tray usage and improved predictability of component sizes, as demonstrated in a study of 88 patients.

The use of PSI resulted in more accurate alignment of knee components during surgery, although some intraoperative adjustments were still necessary, indicating that while PSI is promising, further development is needed for optimal soft tissue balancing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Total and unicompartmental knee replacement. Patient-specific Instrumentation]. Köster, G., Biró, C.[2018]

The eLibra Dynamic Ligament Balancing Device provides surgeons with precise, real-time force measurements during total knee arthroplasty, enhancing the accuracy of ligament balancing.

By using objective dynamic data instead of static landmarks, this device improves the surgical process, potentially leading to better outcomes in knee replacement surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Soft tissue balance in total knee arthroplasty with a force sensor. Camarata, DA.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04849884

To Evaluate the Performance of the CORI™ KNEE ... The TENSIONER communicates directly with CORI software, providing automated data collection. The primary objective is to evaluate the performance of the CORI™ ...

2. smith-nephew.com smith-nephew.com/en-us/health-care-professionals/products/orthopaedics/cori-digital-tensioner

CORI Digital Tensioner for robotic-assisted knee surgery The CORI Digital Tensioner is a purpose-built device that allows surgeons to achieveconsistent joint laxity measurement in the native knee prior to cutting ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11368221/

Robots on the Stage: A Snapshot of the American Robotic ... Computer-assisted robots aid orthopaedic surgeons in implant positioning and bony resection. Surgeons selecting a robot for their practice are faced with ...

4. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf22/K221224.pdf

K221224.pdf - accessdata.fda.gov CORI is indicated for use in surgical knee procedures in which the use of stereotactic surgery may be appropriate, and where reference to rigid.

5. centerwatch.com centerwatch.com/clinical-trials/listings/NCT04848896/study-to-evaluate-the-safety-and-effectiveness-of-the-real-intelligencetm-coritm-in-total-knee-arthroplasty-tka-procedure

Study to Evaluate the Safety and Effectiveness of the REAL ... CORI Robotics is designed to help surgeons in planning and executing certain types of knee surgery involving bone preparation.