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

Rheumatoid Arthritis Clinical Trial

Official title:

A Multi-Centre Study in Patients Undergoing Total Knee Replacement With Smith+Nephew Porous Total Knee Arthroplasty (TKA) System

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05197036
• Other study ID #: POROUS.TKA.SYSTEM.2021.07
• Status: Active, not recruiting
• Start date: December 21, 2021
• Est. completion date: December 10, 2034

Study information

• Verified date: March 2024
• Source: Smith & Nephew, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 500
• Est. completion date: December 10, 2034
• Est. primary completion date: December 10, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Osteoarthritis
• Post-traumatic Arthritis
• Rheumatoid Arthritis

Intervention

Procedure:
• Total Knee Arthroplasty
A surgical procedure to replace both the tibial and femoral articular surfaces with titanium prostheses.

Locations

Country	Name	City	State
Australia	OrthoSport Victoria	Melbourne	Victoria
Australia	Robina Hospital	Robina	Victoria
Australia	St George and Sutherland Centre for Clinical Orthopaedic Research	Sydney	New South Wales
Australia	The Avenue Hospital	Windsor	Victoria
Canada	Concordia Joint Replacement Group	Winnipeg	Manitoba
Netherlands	Medical Center Leeuwarden	Leeuwarden
Netherlands	Sint Maartenskliniek	Ubbergen	Ubbergen,
Sweden	Umeå University Hospital	Umeå
United States	Emory Orthopaedics and Spine Hospital	Atlanta	Georgia
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Orthopaedic Specialists of Connecticut	Brookfield	Connecticut
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Erlanger Health	Chattanooga	Tennessee
United States	Syracuse Orthopedic Specialists	East Syracuse	New York
United States	UTHealth	Houston	Texas
United States	University of Kentucky	Lexington	Kentucky
United States	University of Wisconsin	Madison	Wisconsin
United States	Duke Health	Morrisville	North Carolina
United States	Columbia University	New York	New York
United States	NYU Langone Health Orthopedic Hospital	New York	New York
United States	The Core Institute	Novi	Michigan
United States	Oregon Health & Science University	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Smith & Nephew, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Netherlands,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Implant Survivorship 2 Years Post-Surgery	Implant survivorship is defined as the cumulative proportion of knee implanted components without a revision.	2 years post-surgery
Secondary	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.	Pre-op, 6 weeks, 6 months, 1 year, 2 years, 5 years, and 10 years
Secondary	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.	Pre-op, 6 weeks, 6 months, 1 year, 2 years, 5 years, and 10 years
Secondary	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.	Pre-op, 6 weeks, 6 months, 1 year, 2 years, 5 years, and 10 years
Secondary	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.	6 weeks and 6 months
Secondary	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.	1 year, 2 years, 5 years, and 10 years
Secondary	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.	1 year, 2 Years, 5 years, and 10 years
Secondary	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.	6 months, 1 year, 2 Years, 5 years, and 10 years
Secondary	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.	Post-op through study completion, approximately 10 years
Secondary	Implant Survival Rate Up to 10 Years Post-Operation	Survival rate determined by proportion of participants that required no implant revisions.	1 year, 5 years, and 10 years