LEGION Hinge Knee System for Total Knee Replacement

(LINKS Trial)

Not currently recruiting at 9 trial locations

Overseen By Tammy Clark

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Smith & Nephew, Inc.

Disqualifiers: Malignant tumor, Morbid obesity, Uncontrolled diabetes, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 2 years

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effectiveness of a new knee device called the LEGION Hinge Knee System. It aims to assist individuals with serious knee issues, such as instability or failed knee replacements, by enhancing knee alignment and function. Suitable candidates include those with ongoing knee problems, like arthritis or previous unsuccessful knee surgeries. Participants must be prepared to adhere to the study protocol and attend follow-ups for five years post-surgery.

As a Phase 3 trial, this study represents the final step before FDA approval, providing participants an opportunity to contribute to a potentially groundbreaking treatment.

Do I have to stop taking 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 this hinged revision knee device is safe?

Research has shown that the LEGION Hinge Knee System has been used in various medical settings without higher risks. In one study, four patients received this knee system, and only one required additional surgery, though the reason was not specified. This suggests that most patients do well with the device.

The LEGION Hinge Knee System is designed for patients needing knee replacement due to severe instability or bone loss. Although it has been recalled before, such recalls are common as medical devices undergo continuous improvement. The device is used with bone cement, which helps maintain stability and security.

Overall, current evidence supports the safety of the LEGION Hinge Knee System for most patients. However, like any medical procedure, potential risks exist, and discussing these with a doctor is important. ^{1 2 3 4 5}

Why are researchers excited about this study treatment?

Researchers are excited about the LEGION Hinge Knee System because it offers a potentially groundbreaking approach to knee replacement surgery. Unlike traditional knee replacement options, which typically use fixed or rotating platform designs, the LEGION Hinge allows for greater flexibility and stability. This advanced design can be particularly beneficial for patients with severe knee instability or deformities. By enhancing movement and providing a more customized fit, the LEGION Hinge aims to improve patient outcomes and extend the lifespan of the knee implant.

What evidence suggests that the LEGION Hinge Knee System is effective for knee revision surgery?

Research has shown that the LEGION Hinge Knee System, which participants in this trial will receive, holds promise for those needing knee replacements. One study found that most patients felt satisfied or very satisfied with their new knee over time. Improvements have been observed in knee function and pain reduction. Another study reported that similar knee implants remained effective, with 100% still functioning at one and two years. These findings suggest that the devices are effective and durable for many patients. ^{2 6 7 8 9}

Who Is on the Research Team?

Rachael Winter

Principal Investigator

Smith & Nephew, Inc.

Are You a Good Fit for This Trial?

Inclusion Criteria

Subject has gross knee instability resulting from loss of collateral ligament function, gross bone loss, comminuted fractures of the proximal tibia or distal femur, rheumatoid arthritis, post-traumatic arthritis, osteoarthritis, degenerative arthritis, failed osteotomies, unicompartmental replacement or total knee replacement, or absent or incompetent posterior cruciate ligament and one or both of the collateral ligaments

Subject has a failed primary or revision knee replacement

Subject is skeletally mature in Investigator's judgment i.e., subject is not actively growing or does not have immature bones for any reason

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the LEGION Hinge Knee System and are assessed for safety and efficacy

2 years

Regular follow-up visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 years

What Are the Treatments Tested in This Trial?

Interventions

• LEGION Hinge Knee System

How Is the Trial Designed?

Group I: LEGION Hinge Knee System Experimental Treatment 1 Intervention

This group will be receiving the LEGION Hinge device.

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

Citations

1. clinicaltrials.uihealthcare.org clinicaltrials.uihealthcare.org/studies/study-evaluating-legion-hinge-knee-system

Study Evaluating the Legion™ Hinge Knee System The objective of this study is to demonstrate statistically significant improvements in the original Knee Society Clinical Score (KSCS) from baseline to 1 ...

2. ctv.veeva.com ctv.veeva.com/study/legion-hinge-safety-and-efficacy-study

LEGION Hinge Safety and Efficacy Study - ClinicalTrials.Veeva The purpose of the current investigation is to assess the safety and efficacy of a new hinged revision knee device.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7829011/

Guided-motion hinged knee replacement prosthesis The majority of our patients were either satisfied or very satisfied with their HTKR prosthesis at all follow-up time points. We were unable to determine if the ...

4. clinicaltrial.be clinicaltrial.be/en/details/74133?per_page=20&only_recruiting=0&only_eligible=0&only_active=0

LEGION Hinge Safety and Efficacy Study The objective of this study is to demonstrate statistically significant improvements in the original Knee Society Clinical Score (KSCS) from ...

5. sicot-j.org sicot-j.org/10.1051/sicotj/2025010

Current concepts in total knee arthroplasty: Rotating hinge ... Perrin et al. [14] reported 100% survivorship for primary TKAs with hinged implants at one and two years of follow-up, with 91% and 85.9% survivorship ...

6. accessdata.fda.gov accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=21988817&pc=KRO

SMITH & NEPHEW, INC. LEGION HINGE SYSTEM Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks ...

7. accessdata.fda.gov accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=21061238&pc=JWH

SMITH & NEPHEW, INC. UNKN LEGION HINGE TOTAL KNEE ... It was reported that, 4 patients underwent tka with a legion hinge knee revision system in 2022.From these, one patient was revised due to a non-disclosed ...

8. medicaldevices.icij.org medicaldevices.icij.org/events/usa-device-recall-legion-tm-hk-femoral-assembly-ab6767a7-b546-4c45-8cae-ef3f09958e31

Recall of Device Recall LEGION(TM) HK FEMORAL ... Constrained and hinge knee systems are designed for use in patients in primary and revision surgery. || The LEGION Hinge Knee System is for cemented use only.

9. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf15/K151118.pdf

Smith & Nephew Incorporated Ms. Allison Chan Regulatory ... The Legion Hinge Knee System is used to treat gross knee instability resulting from loss of collateral ligament function, gross bone loss.