CORI™ Knee Tensioner for Knee Replacement Surgery

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

50 Participants Needed

Trial Summary

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.

Is the CORI Knee Tensioner safe for use in knee replacement surgery?

The CORI Knee Tensioner, used in knee replacement surgery, has been associated with improved outcomes, such as reduced manipulation rates, when compared to traditional methods. No specific safety concerns were noted in the studies, suggesting it is generally safe for use in humans. ^{1 2 3 4 5}

How does the CORI™ Knee Tensioner treatment differ from other knee replacement treatments?

The CORI™ Knee Tensioner is unique because it uses a tensioning device that respects the natural anatomy and ligament strains of the knee, improving ligament balance during knee replacement surgery. This approach, combined with computer-assisted navigation, enhances surgical accuracy and reduces the need for postoperative manipulation compared to traditional methods. ^{1 3 6 7 8}

What is the purpose of this trial?

To evaluate the performance of the CORI™ KNEE TENSIONER as an accessory to the CORI™ Surgical System.

Research Team

Kelli Armstrong

Principal Investigator

Smith & Nephew, Inc.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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 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]

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 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]

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]

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]

References

1. United States 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. [2019]

2. Germany pubmed.ncbi.nlm.nih.gov

[Total and unicompartmental knee replacement. Patient-specific Instrumentation]. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Ligament balancing in computer-assisted total knee arthroplasty: improved clinical results with a spring-loaded tensioning device. [2017]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Semiactive robotic-arm system versus patient-specific instrumentation in primary total knee arthroplasty: Efficacy and accuracy. [2023]

5. Czech Republic pubmed.ncbi.nlm.nih.gov

[Use of Patient Specific Instruments at Total Knee Arthroplasty. One-Year Results of a Prospective Randomised Study]. [2017]

6. Germany pubmed.ncbi.nlm.nih.gov

[Advances in soft tissue management in total knee arthroplasty. The use of imageless navigation systems]. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

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

8. United States pubmed.ncbi.nlm.nih.gov

Is the Use of Spreaders an Accurate Method for Ligament Balancing? [2018]