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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Total Knee Arthroplasty | Procedure | A surgical procedure to replace both the tibial and femoral articular surfaces with titanium prostheses. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 years post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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, 2 years, 3 years, 5 years and 10 years |
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Inclusion Criteria:
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:
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.
Subject is 18-80 years old (inclusive).
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Amir Kamali | Smith & Nephew, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory Orthopaedics and Spine Hospital | Atlanta | Georgia | 30084 | United States | ||
| Massachusetts General Hospital |
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| 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, 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. | 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. | 6 months, 2 years, 5 years and 10 years |
| Radiographic Assessment - Implant Migration | Migration will be assessed in accordance with the following definitions:
| 6 months, 2 years, 5 years and 10 years |
| Radiographic Assessment - Progressive Radiolucency | Progressive Radiolucency will be assessed in accordance with the following definitions:
| 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:
| 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. | 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. | 1 year, 2 years, 5 years and 10 years |
| Boston |
| Massachusetts |
| 02114 |
| United States |
| The Core Institute | Novi | Michigan | 48374 | United States |
| Syracuse Orthopedic Specialists | East Syracuse | New York | 13057 | United States |
| NYU Langone Health Orthopedic Hospital | New York | New York | 10016 | United States |
| Columbia University | New York | New York | 10032 | United States |
| Duke Health | Morrisville | North Carolina | 27560 | United States |
| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Erlanger Health | Chattanooga | Tennessee | 37403 | United States |
| UTHealth | Houston | Texas | 77401 | United States |
| University of Wisconsin | Madison | Wisconsin | 52718 | United States |
| St George and Sutherland Centre for Clinical Orthopaedic Research | Sydney | New South Wales | Australia |
| The Avenue Hospital | Windsor | Victoria | 3181 | Australia |
| Concordia Joint Replacement Group | Winnipeg | Manitoba | R2K2M9 | Canada |
| Medical Center Leeuwarden | Leeuwarden | Leeuwarden | 8934 | Netherlands |
| Sint Maartenskliniek | Ubbergen | Ubbergen, | 6574 | Netherlands |
| Umeå University Hospital | Umeå | Umeå | 90737 | Sweden |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001172 | Arthritis, Rheumatoid |
| D001168 | Arthritis |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D019645 | Arthroplasty, Replacement, Knee |
| ID | Term |
|---|---|
| D019643 | Arthroplasty, Replacement |
| D001178 | Arthroplasty |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
| D019651 | Plastic Surgery Procedures |
| D019919 | Prosthesis Implantation |
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