Porous Knee System for Arthritis

Not currently recruiting at 21 trial locations

Overseen By Alison Walker

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Smith & Nephew, Inc.

Disqualifiers: BMI ≥ 40, Hip arthritis, Diabetes, others

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

Compensation: Varies

Number of Visits: 8

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effectiveness of the Porous Total Knee System, a knee implant designed to aid individuals with severe arthritis from wear and tear, injury, or inflammation. The study aims to demonstrate that the implant reduces pain, improves mobility, and remains durable after surgery. Participants will receive one of two versions of the implant, with or without a hydroxyapatite coating. Ideal candidates need a knee replacement due to arthritis or have received this specific implant in the past year. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to the availability of a potentially groundbreaking treatment.

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 Porous Total Knee System is safe for knee joint replacement?

Research shows that the Porous Total Knee System by Smith and Nephew is generally well-tolerated. The FDA has approved this system for knee replacements, indicating a good safety record. Studies have found that both versions of this system—one with a special bone-like coating called hydroxyapatite and one without—perform well over time. The hydroxyapatite coating has been used in other implants with successful long-term results, often surpassing those without it.

In past studies, patients experienced fewer complications and found these knee systems durable. These implants are designed to fit well without needing bone cement, which can sometimes cause problems. Overall, existing evidence supports the safety of these knee systems for individuals needing joint replacement. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

The Porous Total Knee System is unique because it uses a porous design that encourages bone growth and stability. Unlike traditional knee replacements, which often rely on cement for fixation, this system allows the bone to integrate directly with the implant, potentially leading to a more natural feel and longer-lasting results. Researchers are excited about these treatments because they offer two options: one with hydroxyapatite, which further promotes bone bonding, and one without, providing flexibility based on patient needs. These innovations could mean less wear and tear over time and a more tailored approach to knee replacement.

What evidence suggests that this trial's treatments could be effective for knee joint replacement?

Research shows that the LEGION Porous Total Knee System can reduce pain and improve movement for individuals needing knee replacement. Studies indicate that patients using this porous design, which avoids bone cement, often experience long-lasting results. In this trial, participants will receive either the implant version with a special coating called hydroxyapatite, which aids in bonding with bone, or the version without it. The hydroxyapatite-coated version demonstrated good results over 15 to 22 years, often outperforming traditional cemented implants. Both implant versions aim to enhance knee function and provide durability. These findings suggest that the system can offer significant benefits to those with arthritis-related knee problems. ^{2 4 6 7 8}

Who Is on the Research Team?

Amir Kamali

Principal Investigator

Smith & Nephew, Inc.

Are You a Good Fit for This Trial?

Inclusion Criteria

A) Subject needing primary TKA due to degenerative joint disease (primary diagnosis of osteoarthritis), post-traumatic arthritis or inflammatory arthritis.

OR Preoperative KOOS JR and radiographs have been obtained

6-Month KOOS JR and radiographs have been obtained or these can be collected prospectively in window per schedule of events

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Pre-Surgery Assessment

X-rays and questionnaires are administered to assess knee pain, activities of daily living, quality of life, and patient feelings about their knee

1-2 weeks

1 visit (in-person)

Surgery and Immediate Post-Operative Care

Patients undergo total knee replacement surgery with the Smith and Nephew Porous Total Knee System

1 week

Hospital stay for surgery and recovery

Post-Operative Follow-up

Participants are monitored for safety and effectiveness, including radiographic assessments and patient-reported outcomes

5 years

Regular visits at 6 weeks, 6 months, 1 year, 2 years, and 5 years

What Are the Treatments Tested in This Trial?

Interventions

• Porous Total Knee System

How Is the Trial Designed?

Group I: LEGION Porous CR without Hydroxyapatite Experimental Treatment 1 Intervention

Patients who have already received or a due to receive a Porous Tibia + LEGION Porous CR without HA femoral component (min 117 subjects)

Group II: LEGION Porous CR with Hydroxyapatite Experimental Treatment 1 Intervention

Patients who have already received or a due to receive a Porous Tibia + LEGION Porous CR with HA femoral component (min 117 subjects)

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. smith-nephew.com smith-nephew.com/en-us/health-care-professionals/products/orthopaedics/legion-tks

LEGION Total Knee System | Smith+Nephew USA This system is designed to empower surgeons to address diverse challenges and simplify decision-making intraoperatively.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3923926/

Long lasting outcome of hydroxyapatite-coated implants in ... Our results were as good, and often better, than the best cemented or porous published studies. These very encouraging results at 15–22 years make us very ...

3. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf21/K211246.pdf

May 24, 2021 Smith & Nephew, Inc. Leah Hawkins Regulatory ... total knee replacement. The Smith & Nephew Legion CR Porous Plus HA Femoral components are indicated for use without bone cement and are ...

4. smith-nephew-delivery.stylelabs.cloud smith-nephew-delivery.stylelabs.cloud/api/public/content/b2d8872a61984e18b9e6e10d5b699b80?v=997408d2&download=true

Evidence in focus LEGION◊ Total Knee System Following TKA, over 50% of patients report some degree of limitation to their functional ability,16 hence knee function is an important.

5. snnvisionaire.com snnvisionaire.com/media/bcihpqjx/28725-v1-legion-tks-with-conceloc-design-rationale-1021.pdf

Design Rationale LEGION◊ Cementless Total Knee System offers the benefits of CONCELOC◊ technology paired with the confidence of using clinically successful implant designs.

6. aging.networkofcare.org aging.networkofcare.org/sanmateo/CommunityResources/ClinicalTrials/Detail/NCT03720782?keyword=%22Total%20Knee%20Arthroplasty%22

Safety and Performance Study of the Legion Porous ... The purpose of this research is to collect data on patients that had the Legion Porous HA Tibial Baseplates and/or the Legion Porous HA Femoral component ...

7. clinicaltrial.be clinicaltrial.be/en/details/66675?per_page=100&only_recruiting=0&only_eligible=0&only_active=0

Safety and Performance Study of the Legion Porous System... The purpose of this research is to collect data on patients that had the Legion Porous HA Tibial Baseplates and/or the Legion Porous HA Femoral ...

8. trials.arthritis.org trials.arthritis.org/trials/NCT05197036

Study Purpose - Clinical Trial Finder - Arthritis Foundation The aim of this study is to show that most patients who receive the Porous Total Knee System have reduced pain, greater mobility and a long-lasting implant post ...