A Global Clinical Study Investigating the Safety and Effectiveness of Smith and Nephew's Porous Knee System in Patients Who Need a Total Knee Replacement Due to Degenerative Arthritis, Post-traumatic Arthritis or Inflammatory Arthritis

Study Purpose

A clinical trial investigating the safety and effectiveness of Smith and Nephew's FDA-approved Porous Total Knee System, which is used to replace worn away and diseased knee joints. 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-surgery.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years - 80 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. A) Subject needing primary TKA due to degenerative joint disease (primary diagnosis of osteoarthritis), post-traumatic arthritis or inflammatory arthritis. OR. B) Subject has undergone primary TKA with Smith+Nephew Porous knee system in past 12 months to repair degenerative joint disease, post- traumatic arthritis or inflammatory arthritis and all the following conditions have been met:
  • - 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.
  • - 12-Month KOOS JR and radiographs have been obtained or these can be collected prospectively in window per schedule of events.
2. Subject agrees to consent and to follow the prospective study visit schedule (as defined in the study protocol and informed consent form) by signing the Independent Review Board (IRB)/Independent Ethics Committee (IEC) approved informed consent form. 3. Subject is willing to attend study follow-up visits for up to ten (10) years post-surgery. 4. Subject is able to read, understand, and communicate responses to Patient Reported Outcome assessments. 5. Subject is 18-80 years old (inclusive).

Exclusion Criteria:

1. Subject received TKA on the contralateral knee as a revision for a previously failed total or unicondylar knee arthroplasty. 2. Subject has a Body Mass Index (BMI) ≥ 40 at time of surgery. 3. Subject has ipsilateral hip arthritis resulting in flexion contracture. 4. At the time of enrolment, subject has one or more of the following arthroplasties that are not fully healed and well-functioning, as determined by the investigator: Ipsilateral or contralateral primary total hip arthroplasty or hip resurfacing arthroplasty; Contralateral primary total knee or unicondylar knee arthroplasty. 5. Subject has a condition that may interfere with the TKA survival or outcome (e.g. Paget's or Charcot's disease, vascular insufficiency, lupus, muscular atrophy, uncontrolled diabetes, moderate to severe renal insufficiency or neuromuscular disease). 6. Subject has a known allergy to one or more of its components of the study device. 7. Any subject with hardware present in distal femur or proximal tibia. 8. Any subject that meets the definition of a Vulnerable Subject per ISO 14155 Section 3.55. 9. Subject is entered in another drug, biologic, or device study or has been treated with an investigational product in the past 30 days. 10. Subject, in the opinion of the Investigator, has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study including mental illness, drug or alcohol abuse. 11. Subject is known to be at risk for lost to follow-up, or failure to return for scheduled visits. 12. Women who are pregnant, nursing, or of child-bearing potential who are not utilizing highly effective birth control measures. 13. Subjects who have participated previously in this clinical trial and who have been withdrawn.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05197036
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Smith & Nephew, Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Amir Kamali
Principal Investigator Affiliation Smith & Nephew, Inc.
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Osteoarthritis, Post-traumatic Arthritis, Rheumatoid Arthritis
Additional Details

Patients who need a total knee replacement or have recently had a total knee replacement with the Smith and Nephew Porous Total Knee System will be enrolled into the study. Before surgery X-rays will be collected and questionnaires will be administered which ask the patient about knee pain, activities of daily living, quality of life and how they feel about their knee. The same X-rays and questionnaires will be asked before surgery and then after surgery at various intervals up to 10 years post-surgery.

Arms & Interventions

Arms

: LEGION Porous CR with Hydroxyapatite

Patients who have already received or a due to receive a Porous Tibia + LEGION Porous CR with HA femoral component (max 250 subjects)

: LEGION Porous CR without Hydroxyapatite

Patients who have already received or a due to receive a Porous Tibia + LEGION Porous CR without HA femoral component (max 250 subjects)

Interventions

Procedure: - Total Knee Arthroplasty

A surgical procedure to replace both the tibial and femoral articular surfaces with titanium prostheses.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Kentucky, Lexington, Kentucky

Status

Not yet recruiting

Address

University of Kentucky

Lexington, Kentucky, 40508

Site Contact

Stephen Duncan, MD

[email protected]

859-684-9300

NYU Langone Health Orthopedic Hospital, New York, New York

Status

Recruiting

Address

NYU Langone Health Orthopedic Hospital

New York, New York, 10016

Site Contact

Ran Schwarzkopf, MD

[email protected]

212-598-6000