OsteoarthritisNCT05197036
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
An observational study of Osteoarthritis and Post-traumatic Arthritis, run by Smith & Nephew, Inc. at 18 sites in 5 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Osteoarthritis, Post-traumatic Arthritis, Rheumatoid Arthritis
- What is being tested?
- Total Knee Arthroplasty
- Type of treatment
- Surgery or procedure
- How many people
- 299 participants
- Where
- 18 sitesin 5 countries
- Study dates
- 21 Dec 2021to 25 Dec 2033
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient population will be selected by investigators from their clinics. Patients who report pain/mobility issues and who have been recommended for total knee replacement with Porous Total Knee System by their surgeon.
Who may be able to join
- A) Subject needing primary TKA due to degenerative joint disease (primary diagnosis of osteoarthritis), post-traumatic arthritis or inflammatory arthritis.
- OR
- 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
- 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.
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- Subject is willing to attend study follow-up visits for up to five (5) years post-surgery.
- Subject is able to read, understand, and communicate responses to Patient Reported Outcome assessments.
- Subject is 18-80 years old (inclusive).
Who cannot join
- Subject received TKA on the contralateral knee as a revision for a previously failed total or unicondylar knee arthroplasty.
- Subject has a Body Mass Index (BMI) ≥ 40 at time of surgery.
- Subject has ipsilateral hip arthritis resulting in flexion contracture.
- 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.
- 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).
- Subject has a known allergy to one or more of its components of the study device.
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- Any subject with hardware present in distal femur or proximal tibia.
- Any subject that meets the definition of a Vulnerable Subject per ISO 14155 Section 3.55.
- Subject is entered in another drug, biologic, or device study or has been treated with an investigational product in the past 30 days.
- 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.
- Subject is known to be at risk for lost to follow-up, or failure to return for scheduled visits.
- Women who are pregnant, nursing, or of child-bearing potential who are not utilizing highly effective birth control measures.
- Subjects who have participated previously in this clinical trial and who have been withdrawn.
Trial locations and contacts
18 sites in 5 countries.
18 sites in 5 countries
United States12 sites
Emory Orthopaedics and Spine Hospital
Atlanta, Georgia, 30084
Massachusetts General Hospital
Boston, Massachusetts, 02114
Medical University of South Carolina
Charleston, South Carolina, 29425
Erlanger Health
Chattanooga, Tennessee, 37403
Syracuse Orthopedic Specialists
East Syracuse, New York, 13057
UTHealth
Houston, Texas, 77401
University of Wisconsin
Madison, Wisconsin, 52718
Duke Health
Morrisville, North Carolina, 27560
NYU Langone Health Orthopedic Hospital
New York, New York, 10016
Columbia University
New York, New York, 10032
The Core Institute
Novi, Michigan, 48374
Oregon Health & Science University
Portland, Oregon, 97239
Australia2 sites
St George and Sutherland Centre for Clinical Orthopaedic Research
Sydney, New South Wales
The Avenue Hospital
Windsor, Victoria, 3181
Netherlands2 sites
Medical Center Leeuwarden
Leeuwarden, Leeuwarden, 8934
Sint Maartenskliniek
Ubbergen, Ubbergen,, 6574
About this study
Official title: A Multi-Centre Study in Patients Undergoing Total Knee Replacement With Smith+Nephew Porous Total Knee Arthroplasty (TKA) System
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.
Read the detailed description
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.
- Being tested
- Total Knee Arthroplasty
- Keywords
- Arthritis, Osteoarthritis, Rheumatoid Arthritis, Post-traumatic Arthritis, Total Knee Arthroplasty (TKA), Knee Replacement, Cementless, Knee, Smith and Nephew
- Medical subject headings
- Osteoarthritis, Arthritis, Rheumatoid, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Knee ArthroplastyProcedure or surgery
Also called Total Knee Replacement
A surgical procedure to replace both the tibial and femoral articular surfaces with titanium prostheses.
| Study group | Role | What they receive |
|---|---|---|
| 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 (min 117 subjects) Receives: Procedure: Total Knee Arthroplasty | |
| 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 (min 117 subjects) Receives: Procedure: Total Knee Arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant Survivorship (femoral and/or tibial component) 2 Years Post-Surgery
Survivorship of the femoral and/or tibial component of the implant is defined as the cumulative proportion of femoral and/or tibial components without a revision.
Measured: 2 years post-surgery
Secondary outcomes (9)
Patient Reported Outcomes - Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS JR)
KOOS JR assesses patient stiffness (1 item), pain (4 items), and functions of daily living (2 items). Scores range from 0 to 100 with a score of 0 indicating total knee disability and 100 indicating perfect knee health.
Measured: Pre-op, 6 weeks, 6 months, 2 years, 3 years, 5 years and 10 years
Patient Reported Outcomes - Oxford Knee Score (OKS)
The OKS contains 12 equally weighted questions on activities of daily living. Responses to each question range from 0-4 with a range of a possible overall score from 0-48. A score of 0 is the worst possible outcome while a score of 48 is the best possible outcome.
Measured: Pre-op, 6 weeks, 6 months, 2 years, 3 years, 5 years and 10 years
Patient Reported Outcomes - Forgotten Joint Score (FJS)
The FJS questionnaire focuses on the study participant's awareness of a specific joint in everyday life. Joint awareness can be simply defined as any unintended perception of a joint. The FJS for an individual participant is rated on a scale of 1-100 where 100 is the best/max score.
Measured: Pre-op, 6 weeks, 6 months, 2 years, 3 years, 5 years and 10 years
Radiographic Assessment - Implant Position
Implant position will be assessed by the femoral flexion angle, tibial angle, and posterior tibial slope angle from AP and lateral radiographs.
Measured: 6 months, 2 years, 5 years and 10 years
Radiographic Assessment - Implant Migration
Migration will be assessed in accordance with the following definitions:
- 0. Absent: Absence of progressive radiolucency OR absence of movement of the implant.
- 1. Present: Presence of progressive radiolucency AND presence of movement of the implant.
Measured: 6 months, 2 years, 5 years and 10 years
Radiographic Assessment - Progressive Radiolucency
Progressive Radiolucency will be assessed in accordance with the following definitions:
- 0. Absent: No evidence of progressive radiolucency at the bone-cement interface relative to the last measured Radiolucent Line time point.
- 1. Present: Presence of an increase >1 mm of the Radiolucent Line (Bone-Cement) width and/or new involvement of additional component zones relative to the last measured Radiolucent Line time point.
Measured: 6 months, 2 years, 5 years and 10 years
Radiographic Assessment - Implant Loosening
Both aseptic and septic component loosening will be evaluated to assess loss of implant fixation with the following definitions:
- 0. Absent: No evidence of specific imaging features of loosening in the joint space.
- 1. Present: Presence of apparent imaging features of loosening in the joint space.
Measured: 6 months, 2 years, 5 years and 10 years
Post-Operation Device Related Re-Interventions Related to Operative Knee
Count of device-related re-interventions that occur related to the operative knee post-operation.
Measured: Post-op through study completion, approximately 10 years
Implant Survival Rate Up to 10 Years Post-Operation
Survivorship of the implant will be defined as the cumulative proportion of all knee implant components without a revision.
Measured: 1 year, 2 years, 5 years and 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2022
- Study start21 Dec 2021
- Primary completion11 Jun 2026
- Study completion25 Dec 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Smith & Nephew, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 299 participants (actual)
Sponsor and investigators
- Lead sponsor
- Smith & Nephew, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Amir Kamali, Study director, Smith & Nephew, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05197036
- Sponsor's protocol ID
- POROUS.TKA.SYSTEM.2021.07
- Status last verified
- Aug 2026
- First submitted
- 4 Jan 2022
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Centre Study in Patients Undergoing Total Knee Replacement With Smith+Nephew Porous Total Knee Arthroplasty (TKA) System
- ClinicalTrials.gov ID
- NCT05197036
- Acronym / sponsor ID
- POROUS.TKA.SYSTEM.2021.07
- Keywords
- Arthritis, Osteoarthritis, Rheumatoid Arthritis, Post-traumatic Arthritis, Total Knee Arthroplasty (TKA), Knee Replacement, Cementless, Knee
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 299 participants (actual)
- Lead sponsor
- Smith & Nephew, Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Dec 2021 (actual)
- Primary completion
- 11 Jun 2026 (actual)
- Study completion
- 25 Dec 2033 (estimated)
- First posted
- 19 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LEGION Porous CR with Hydroxyapatite | – | Procedure: Total Knee ArthroplastyPatients who have already received or a due to receive a Porous Tibia + LEGION Porous CR with HA femoral component (min 117 subjects) |
| LEGION Porous CR without Hydroxyapatite | – | Procedure: Total Knee ArthroplastyPatients who have already received or a due to receive a Porous Tibia + LEGION Porous CR without HA femoral component (min 117 subjects) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient population will be selected by investigators from their clinics. Patients who report pain/mobility issues and who have been recommended for total knee replacement with Porous Total Knee System by their surgeon.
Key inclusion criteria (9 listed)
- A) Subject needing primary TKA due to degenerative joint disease (primary diagnosis of osteoarthritis), post-traumatic arthritis or inflammatory arthritis.
- OR
- 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.
- Subject is willing to attend study follow-up visits for up to five (5) years post-surgery.
- Subject is able to read, understand, and communicate responses to Patient Reported Outcome assessments.
Key exclusion criteria (13 listed)
- Subject received TKA on the contralateral knee as a revision for a previously failed total or unicondylar knee arthroplasty.
- Subject has a Body Mass Index (BMI) ≥ 40 at time of surgery.
- Subject has ipsilateral hip arthritis resulting in flexion contracture.
- 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.
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total Knee ArthroplastyAlso: Total Knee ReplacementA surgical procedure to replace both the tibial and femoral articular surfaces with titanium prostheses. | Procedure or surgery | LEGION Porous CR with Hydroxyapatite, LEGION Porous CR without Hydroxyapatite |
Primary outcome
Implant Survivorship (femoral and/or tibial component) 2 Years Post-Surgery
Time frame: 2 years post-surgery
Survivorship of the femoral and/or tibial component of the implant is defined as the cumulative proportion of femoral and/or tibial components without a revision.
9 secondary outcomes
Patient Reported Outcomes - Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS JR)
Time frame: Pre-op, 6 weeks, 6 months, 2 years, 3 years, 5 years and 10 years
Patient Reported Outcomes - Oxford Knee Score (OKS)
Time frame: Pre-op, 6 weeks, 6 months, 2 years, 3 years, 5 years and 10 years
Patient Reported Outcomes - Forgotten Joint Score (FJS)
Time frame: Pre-op, 6 weeks, 6 months, 2 years, 3 years, 5 years and 10 years
Radiographic Assessment - Implant Position
Time frame: 6 months, 2 years, 5 years and 10 years
Radiographic Assessment - Implant Migration
Time frame: 6 months, 2 years, 5 years and 10 years
Radiographic Assessment - Progressive Radiolucency
Time frame: 6 months, 2 years, 5 years and 10 years
Radiographic Assessment - Implant Loosening
Time frame: 6 months, 2 years, 5 years and 10 years
Post-Operation Device Related Re-Interventions Related to Operative Knee
Time frame: Post-op through study completion, approximately 10 years
Implant Survival Rate Up to 10 Years Post-Operation
Time frame: 1 year, 2 years, 5 years and 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amir Kamali study director
Smith & Nephew, Inc.
18 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis and Post-traumatic Arthritis, run by Smith & Nephew, Inc. at 18 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States, Australia, Netherlands, Canada, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implant Survivorship (femoral and/or tibial component) 2 Years Post-Surgery (time frame: 2 years post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.