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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05197036
Registration number
NCT05197036
Ethics application status
Date submitted
4/01/2022
Date registered
19/01/2022
Titles & IDs
Public title
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
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Scientific title
A Multi-Centre Study in Patients Undergoing Total Knee Replacement With Smith+Nephew Porous Total Knee Arthroplasty (TKA) System
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Secondary ID [1]
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POROUS.TKA.SYSTEM.2021.07
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis
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Post-traumatic Arthritis
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Rheumatoid Arthritis
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Condition category
Condition code
Musculoskeletal
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Osteoarthritis
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Inflammatory and Immune System
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Rheumatoid arthritis
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Treatment: Surgery - Total Knee Arthroplasty
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)
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)
Treatment: Surgery: Total Knee Arthroplasty
A surgical procedure to replace both the tibial and femoral articular surfaces with titanium prostheses.
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Intervention code [1]
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Treatment: Surgery
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Implant Survivorship (femoral and/or tibial component) 2 Years Post-Surgery
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Assessment method [1]
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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.
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Timepoint [1]
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2 years post-surgery
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Secondary outcome [1]
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Patient Reported Outcomes - Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS JR)
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Assessment method [1]
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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.
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Timepoint [1]
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Pre-op, 6 weeks, 6 months, 2 years and 5 years
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Secondary outcome [2]
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Patient Reported Outcomes - Oxford Knee Score (OKS)
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Assessment method [2]
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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.
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Timepoint [2]
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Pre-op, 6 weeks, 6 months, 2 years and 5 years
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Secondary outcome [3]
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Patient Reported Outcomes - Forgotten Joint Score (FJS)
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Assessment method [3]
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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.
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Timepoint [3]
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Pre-op, 6 weeks, 6 months, 2 years and 5 years
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Secondary outcome [4]
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Radiographic Assessment - Implant Position
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Assessment method [4]
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Implant position will be assessed by the femoral flexion angle, tibial angle, and posterior tibial slope angle from AP and lateral radiographs.
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Timepoint [4]
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6 months, 2 years and 5 years
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Secondary outcome [5]
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Radiographic Assessment - Implant Migration
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Assessment method [5]
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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.
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Timepoint [5]
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6 months, 2 years and 5 years
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Secondary outcome [6]
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Radiographic Assessment - Progressive Radiolucency
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Assessment method [6]
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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.
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Timepoint [6]
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6 months, 2 years and 5 years
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Secondary outcome [7]
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Radiographic Assessment - Implant Loosening
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Assessment method [7]
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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.
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Timepoint [7]
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6 months, 2 years and 5 years
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Secondary outcome [8]
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Post-Operation Device Related Re-Interventions Related to Operative Knee
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Assessment method [8]
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Count of device-related re-interventions that occur related to the operative knee post-operation.
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Timepoint [8]
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Post-op through study completion, approximately 5 years
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Secondary outcome [9]
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Implant Survival Rate Up to 5 Years Post-Operation
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Assessment method [9]
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Survivorship of the implant will be defined as the cumulative proportion of all knee implant components without a revision.
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Timepoint [9]
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1 year, 2 years and 5 years
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Eligibility
Key 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
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 five (5) 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).
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Minimum age
18
Years
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Maximum age
80
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
21/12/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
25/12/2028
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Actual
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Sample size
Target
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Accrual to date
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Final
299
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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St George and Sutherland Centre for Clinical Orthopaedic Research - Sydney
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Recruitment hospital [2]
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OrthoSport Victoria - Melbourne
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Recruitment hospital [3]
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Robina Hospital - Robina
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Recruitment hospital [4]
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The Avenue Hospital - Windsor
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Recruitment postcode(s) [1]
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- Sydney
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Recruitment postcode(s) [2]
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3121 - Melbourne
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Recruitment postcode(s) [3]
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3121 - Robina
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Recruitment postcode(s) [4]
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3181 - Windsor
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Georgia
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Country [2]
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United States of America
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State/province [2]
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Kentucky
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Country [3]
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United States of America
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State/province [3]
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Massachusetts
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Country [4]
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United States of America
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State/province [4]
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Michigan
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Country [5]
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United States of America
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State/province [5]
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New York
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Country [6]
0
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United States of America
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State/province [6]
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North Carolina
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Country [7]
0
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United States of America
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State/province [7]
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Oregon
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Country [8]
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United States of America
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State/province [8]
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South Carolina
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Country [9]
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United States of America
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State/province [9]
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Tennessee
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Country [10]
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United States of America
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State/province [10]
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Texas
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Country [11]
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United States of America
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State/province [11]
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Wisconsin
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Country [12]
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Canada
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State/province [12]
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Manitoba
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Country [13]
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Netherlands
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State/province [13]
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Ubbergen,
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Country [14]
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Netherlands
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State/province [14]
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Leeuwarden
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Country [15]
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Sweden
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State/province [15]
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Umeå
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Smith & Nephew, Inc.
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief 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. 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.
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Trial website
https://clinicaltrials.gov/study/NCT05197036
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Amir Kamali
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Address
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Smith & Nephew, Inc.
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05197036