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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
Scientific title
A Multi-Centre Study in Patients Undergoing Total Knee Replacement With Smith+Nephew Porous Total Knee Arthroplasty (TKA) System
Secondary ID [1] 0 0
POROUS.TKA.SYSTEM.2021.07
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis 0 0
Post-traumatic Arthritis 0 0
Rheumatoid Arthritis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
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.
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Implant Survivorship (femoral and/or tibial component) 2 Years Post-Surgery
Timepoint [1] 0 0
2 years post-surgery
Secondary outcome [1] 0 0
Patient Reported Outcomes - Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS JR)
Timepoint [1] 0 0
Pre-op, 6 weeks, 6 months, 2 years and 5 years
Secondary outcome [2] 0 0
Patient Reported Outcomes - Oxford Knee Score (OKS)
Timepoint [2] 0 0
Pre-op, 6 weeks, 6 months, 2 years and 5 years
Secondary outcome [3] 0 0
Patient Reported Outcomes - Forgotten Joint Score (FJS)
Timepoint [3] 0 0
Pre-op, 6 weeks, 6 months, 2 years and 5 years
Secondary outcome [4] 0 0
Radiographic Assessment - Implant Position
Timepoint [4] 0 0
6 months, 2 years and 5 years
Secondary outcome [5] 0 0
Radiographic Assessment - Implant Migration
Timepoint [5] 0 0
6 months, 2 years and 5 years
Secondary outcome [6] 0 0
Radiographic Assessment - Progressive Radiolucency
Timepoint [6] 0 0
6 months, 2 years and 5 years
Secondary outcome [7] 0 0
Radiographic Assessment - Implant Loosening
Timepoint [7] 0 0
6 months, 2 years and 5 years
Secondary outcome [8] 0 0
Post-Operation Device Related Re-Interventions Related to Operative Knee
Timepoint [8] 0 0
Post-op through study completion, approximately 5 years
Secondary outcome [9] 0 0
Implant Survival Rate Up to 5 Years Post-Operation
Timepoint [9] 0 0
1 year, 2 years and 5 years

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).
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/12/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
25/12/2028
Actual
Sample size
Target
Accrual to date
Final
299
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
St George and Sutherland Centre for Clinical Orthopaedic Research - Sydney
Recruitment hospital [2] 0 0
OrthoSport Victoria - Melbourne
Recruitment hospital [3] 0 0
Robina Hospital - Robina
Recruitment hospital [4] 0 0
The Avenue Hospital - Windsor
Recruitment postcode(s) [1] 0 0
- Sydney
Recruitment postcode(s) [2] 0 0
3121 - Melbourne
Recruitment postcode(s) [3] 0 0
3121 - Robina
Recruitment postcode(s) [4] 0 0
3181 - Windsor
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Georgia
Country [2] 0 0
United States of America
State/province [2] 0 0
Kentucky
Country [3] 0 0
United States of America
State/province [3] 0 0
Massachusetts
Country [4] 0 0
United States of America
State/province [4] 0 0
Michigan
Country [5] 0 0
United States of America
State/province [5] 0 0
New York
Country [6] 0 0
United States of America
State/province [6] 0 0
North Carolina
Country [7] 0 0
United States of America
State/province [7] 0 0
Oregon
Country [8] 0 0
United States of America
State/province [8] 0 0
South Carolina
Country [9] 0 0
United States of America
State/province [9] 0 0
Tennessee
Country [10] 0 0
United States of America
State/province [10] 0 0
Texas
Country [11] 0 0
United States of America
State/province [11] 0 0
Wisconsin
Country [12] 0 0
Canada
State/province [12] 0 0
Manitoba
Country [13] 0 0
Netherlands
State/province [13] 0 0
Ubbergen,
Country [14] 0 0
Netherlands
State/province [14] 0 0
Leeuwarden
Country [15] 0 0
Sweden
State/province [15] 0 0
Umeå

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Smith & Nephew, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Amir Kamali
Address 0 0
Smith & Nephew, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment


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