Back to results14022 ATTUNE Cementless RP Clinical Performance Evaluation
Primary Purpose
Osteoarthritis
Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Cementless Total Knee Arthroplasty
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis focused on measuring Arthroplasty, replacement, Knee, function, radiographic, survivorship
Eligibility Criteria
Inclusion Criteria:
- Subject is male or female and between the ages of 22 and 80 years at the time of surgery, inclusive.
- Subject was diagnosed with NIDJD.
- Subject, in the opinion of the Investigator, is a suitable candidate for cementless primary TKA using the devices described in this CIP with either resurfaced or non-resurfaced patellae.
- Subject that is willing to give voluntary, written informed consent to participate in this clinical investigation and authorize the transfer of his/her information to the Sponsor
- Subject is currently not bedridden
- Subject, in the opinion of the Investigator, is able to understand this clinical investigation and is willing and able to perform all study procedures and follow-up visits and co-operate with investigational procedures.
- Subject is able to read, and comprehend the Informed Consent Document as well as complete the required PROs in either English or one of the available translations.
Exclusion Criteria:
- The Subject is a woman who is pregnant or lactating.
- Contralateral knee has already been enrolled in this study .
- Subject had a contralateral amputation.
- Previous partial knee replacement (unicompartmental, bicompartmental or patellofemoral joint replacement), patellectomy, high tibial osteotomy or primary TKA in affected knee.
- Subject is currently diagnosed with radicular pain from the spine that radiates into the limb to receive TKA.
- Subject has participated in a clinical investigation with an investigational product (drug or device) in the last three (3) months.
- Subject is currently involved in any personal injury litigation, medical-legal or worker's compensation claims.
- Subject, in the opinion of the Investigator, is a drug or alcohol abuser (in the last 5 years) or has a psychological disorder that could affect their ability to complete patient reported questionnaires or be compliant with follow-up requirements.
- Subject was diagnosed and is taking prescription medications to treat a muscular disorder that limits mobility due to severe stiffness and pain such as fibromyalgia or polymyalgia.
- Subject has a significant neurological or musculoskeletal disorder(s) or disease that may adversely affect gait or weight bearing (e.g., muscular dystrophy, multiple sclerosis, Charcot disease).
- Subject is suffering from inflammatory arthritis (e.g., rheumatoid arthritis, juvenile rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus, etc.).
- Subject has a medical condition with less than five (5) years life expectancy.
- Uncontrolled gout
Sites / Locations
- Colorado Joint Replacement
- Florida Research Associates
- Dartmouth-Hitchcock Medical Center
- New London Hospital
- Rothman Institute
- SUNY downstate Medical Center
- UNC Chapel Hill
- Associated Orthopaedics of Kingsport
- Texas Tech University Heath Science Center
- Hampton Roads Orthopaedics and Sports Medicine
- Krankenhaus der Barmherzigen Schwestern Ried im Innkreis
- Foothills Medical Centre, University of Calgary
- CHU de la Cavale Blanche
- Sevice de Chirurgie Orthoedique et Traumatologique
- Klinikum Garmisch-Partenkirchen GmbH
- South Infirmary Victoria University Hospital
- Elkerliek Ziekenhuis
- University of Otago
- Wrightington Hospital
- Nottingham University Hospitals NHS Trust
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ATTUNE Cementless RP TKA
Arm Description
Subjects will receive a cementless, rotating platform total knee arthroplasty
Outcomes
Primary Outcome Measures
Patient-reported Outcome: Knee Injury and Osteoarthritis Outcome Score Activities of Daily Living (KOOS ADL)
The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient self-administered questionnaire that consists of 42 questions and include the WOMAC Osteoarthritis index. The KOOS consists of 5 subscales: pain, other symptoms, activities of daily living (ADL), sport and recreational function and knee related quality of life. Each question has 5 Likert-like response options. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.
Secondary Outcome Measures
Patient-reported Outcome: Pre-surgical/Post-surgical Patient's Knee Implant Performance (PKIP)
The Pre Surgical and/or Post-surgical Patient's Knee Implant Performance (PKIP) questionnaire is a patient self-administered questionnaire that consists of 25 questions relating to the patient's awareness of their knee. Questions include the patient's self-confidence about the current status of their knee performance, stability, and overall satisfaction. Each question has a 5, 6 or 10 Likert- like response option.
Patient-reported Outcome: Knee Injury and Osteoarthritis Outcome Score (KOOS)
The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient self-administered questionnaire that consists of 42 questions and include the WOMAC Osteoarthritis index. The KOOS consists of 5 subscales: pain, other symptoms, activities of daily living (ADL), sport and recreational function and knee related quality of life. Each question has 5 Likert-like response options. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.
Combination of Patient-reported and Clinical-reported Outcome: Knee Society 2011
The Knee Society Score is a self-administered questionnaire. The subject completes questions regarding: Symptoms (3 questions), Patient Satisfaction (5 questions), Patient Expectations (3 questions), Functional Activities (5 questions), Standard Activities (6 questions), Advanced Activities (5 questions), and Discretionary Knee Activities ( 4 questions). The surgeon completes questions regarding objective knee indicators. Likert responses are used, typically with five response options.
Patient Reported Outcome: EuroQol 5D 3L questionnaire (EQ-5D-3L)
EuroQol 5D 3L questionnaire is a standardized instrument for use as a measure of health outcome that is designed for completion by the subject.
Modified VAS Pain Score: Pain and Satisfaction
VAS Pain Score is a standardized instrument for use as a measure of pain and satisfaction that is designed for completion by the subject. This modified version has scores that are discrete numbers rather than a continual scale
Type and Frequency of Adverse Events (AEs) for all enrolled subjects
All Serious AEs must be reported to Sponsor. All device-related or procedure-related adverse events must be reported to Sponsor.
Survivorship
Kaplan-Meier survival analysis will be used to calculate the survivorship of all 2 configurations (CR RP, PS RP)
Survivorship
Kaplan-Meier survival analysis will be used to calculate the survivorship of all 2 configurations (CR RP, PS RP)
Implant fixation: Radiographic assessment of bone-implant interface performance
Radiographic success is defined as: absence of progressive radiolucent lines greater than or equal to 2mm in any one zone; absence of lytic lesions in any zone; absence of individual component position change >3degrees in any plane.
Implant fixation: Radiographic assessment of bone-implant interface performance
Radiographic success is defined as: absence of progressive radiolucent lines greater than or equal to 2mm in any one zone; absence of lytic lesions in any zone; absence of individual component position change >3degrees in any plane.
Implant fixation: Radiographic assessment of bone-implant interface performance
Radiographic success is defined as: absence of progressive radiolucent lines greater than or equal to 2mm in any one zone; absence of lytic lesions in any zone; absence of individual component position change >3degrees in any plane.
Implant fixation: Radiographic assessment of bone-implant interface performance
Radiographic success is defined as: absence of progressive radiolucent lines greater than or equal to 2mm in any one zone; absence of lytic lesions in any zone; absence of individual component position change >3degrees in any plane.
Evaluate changes in femoral component and tibial component alignment
Radiographs will be reviewed by an independent radiographic reviewer (IRR) in order to minimize bias of radiographic outcomes. Data from the IRR radiographic evaluations will be used to evaluate femoral and tibial component alignment over time.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02839850
Brief Title
14022 ATTUNE Cementless RP Clinical Performance Evaluation
Official Title
Multi-Center Clinical Evaluation of the ATTUNE Cementless Rotating Platform Total Knee Arthroplasty
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 1, 2016 (Actual)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
September 1, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
DePuy Orthopaedics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The primary objective of this study is to examine the change from pre-operative baseline to two year postoperative functional performance improvement for the ATTUNE primary, cementless TKA RP system as measured with the KOOS questionnaire (KOOS-ADL sub-score). This will be carried out for two configurations: cruciate retaining rotating platform (ATTUNE Cementless CR RP) and posterior stabilized rotating platform (ATTUNE Cementless PS RP).
Detailed Description
The secondary objectives of this study are:
Evaluate change from preoperative baseline in post-operative outcomes using additional patient reported measures at 2 years: PKIP (overall and sub-scores), KOOS (overall and sub-scores), AKS and EQ-5D-3L.
Evaluate change from preoperative baseline in pain and satisfaction over time as measured using a modified VAS Pain Score (discrete numbers rather than a continual scale) at 2yr.
Evaluate type and frequency of Adverse Events
Evaluate survivorship of the ATTUNE Primary Cementless TKA system for the CR RP and PS RP configurations using Kaplan-Meier survival analysis at 2yr and 5yrs.
Evaluate primary, cementless ATTUNE TKA fixation through zonal radiographic analysis of the bone-implant interface at 6wk, 6mo, 1yr, and 2yr after surgery.
Evaluate any changes in anatomic tibiofemoral, femoral component and tibial component alignment at 2 years compared to the first postoperative radiographs.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
Keywords
Arthroplasty, replacement, Knee, function, radiographic, survivorship
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
An independent radiographic reviewer will be assessing all radiographs from the study.
Allocation
N/A
Enrollment
540 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ATTUNE Cementless RP TKA
Arm Type
Experimental
Arm Description
Subjects will receive a cementless, rotating platform total knee arthroplasty
Intervention Type
Device
Intervention Name(s)
Cementless Total Knee Arthroplasty
Intervention Description
Patients will undergo a primary total knee replacement using one of the two configurations of the ATTUNE Cementless knee (CR RP or PS RP)
Primary Outcome Measure Information:
Title
Patient-reported Outcome: Knee Injury and Osteoarthritis Outcome Score Activities of Daily Living (KOOS ADL)
Description
The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient self-administered questionnaire that consists of 42 questions and include the WOMAC Osteoarthritis index. The KOOS consists of 5 subscales: pain, other symptoms, activities of daily living (ADL), sport and recreational function and knee related quality of life. Each question has 5 Likert-like response options. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.
Time Frame
Minimum 2 years (670-1033 days after surgery)
Secondary Outcome Measure Information:
Title
Patient-reported Outcome: Pre-surgical/Post-surgical Patient's Knee Implant Performance (PKIP)
Description
The Pre Surgical and/or Post-surgical Patient's Knee Implant Performance (PKIP) questionnaire is a patient self-administered questionnaire that consists of 25 questions relating to the patient's awareness of their knee. Questions include the patient's self-confidence about the current status of their knee performance, stability, and overall satisfaction. Each question has a 5, 6 or 10 Likert- like response option.
Time Frame
Minimum 2 years (670-1033 days after surgery)
Title
Patient-reported Outcome: Knee Injury and Osteoarthritis Outcome Score (KOOS)
Description
The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient self-administered questionnaire that consists of 42 questions and include the WOMAC Osteoarthritis index. The KOOS consists of 5 subscales: pain, other symptoms, activities of daily living (ADL), sport and recreational function and knee related quality of life. Each question has 5 Likert-like response options. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.
Time Frame
Minimum 2 years (670-1033 days after surgery)
Title
Combination of Patient-reported and Clinical-reported Outcome: Knee Society 2011
Description
The Knee Society Score is a self-administered questionnaire. The subject completes questions regarding: Symptoms (3 questions), Patient Satisfaction (5 questions), Patient Expectations (3 questions), Functional Activities (5 questions), Standard Activities (6 questions), Advanced Activities (5 questions), and Discretionary Knee Activities ( 4 questions). The surgeon completes questions regarding objective knee indicators. Likert responses are used, typically with five response options.
Time Frame
Minimum 2 years (670-1033 days after surgery)
Title
Patient Reported Outcome: EuroQol 5D 3L questionnaire (EQ-5D-3L)
Description
EuroQol 5D 3L questionnaire is a standardized instrument for use as a measure of health outcome that is designed for completion by the subject.
Time Frame
Minimum 2 years (670-1033 days after surgery)
Title
Modified VAS Pain Score: Pain and Satisfaction
Description
VAS Pain Score is a standardized instrument for use as a measure of pain and satisfaction that is designed for completion by the subject. This modified version has scores that are discrete numbers rather than a continual scale
Time Frame
Minimum 2 years (670-1033 days after surgery)
Title
Type and Frequency of Adverse Events (AEs) for all enrolled subjects
Description
All Serious AEs must be reported to Sponsor. All device-related or procedure-related adverse events must be reported to Sponsor.
Time Frame
Pre-op (-90 to -1 days before surgery), 6 weeks (1-90 days after surgery), 6 months (91-303 days after surgery), minimum 1 year (304-669 days after surgery), minimum 2 years (670-1033 days after surgery), minimum 5 years (1764-2190 days after surgery)
Title
Survivorship
Description
Kaplan-Meier survival analysis will be used to calculate the survivorship of all 2 configurations (CR RP, PS RP)
Time Frame
Minimum 2 years (670-1033 days after surgery)
Title
Survivorship
Description
Kaplan-Meier survival analysis will be used to calculate the survivorship of all 2 configurations (CR RP, PS RP)
Time Frame
Minimum 5 years (1764-2190 days after surgery)
Title
Implant fixation: Radiographic assessment of bone-implant interface performance
Description
Radiographic success is defined as: absence of progressive radiolucent lines greater than or equal to 2mm in any one zone; absence of lytic lesions in any zone; absence of individual component position change >3degrees in any plane.
Time Frame
6 weeks (1-90 days after surgery)
Title
Implant fixation: Radiographic assessment of bone-implant interface performance
Description
Radiographic success is defined as: absence of progressive radiolucent lines greater than or equal to 2mm in any one zone; absence of lytic lesions in any zone; absence of individual component position change >3degrees in any plane.
Time Frame
6 months (91-303 days after surgery)
Title
Implant fixation: Radiographic assessment of bone-implant interface performance
Description
Radiographic success is defined as: absence of progressive radiolucent lines greater than or equal to 2mm in any one zone; absence of lytic lesions in any zone; absence of individual component position change >3degrees in any plane.
Time Frame
Minimum 1 year (304-669 days after surgery).
Title
Implant fixation: Radiographic assessment of bone-implant interface performance
Description
Radiographic success is defined as: absence of progressive radiolucent lines greater than or equal to 2mm in any one zone; absence of lytic lesions in any zone; absence of individual component position change >3degrees in any plane.
Time Frame
Minimum 2 years (670-1033 days after surgery)
Title
Evaluate changes in femoral component and tibial component alignment
Description
Radiographs will be reviewed by an independent radiographic reviewer (IRR) in order to minimize bias of radiographic outcomes. Data from the IRR radiographic evaluations will be used to evaluate femoral and tibial component alignment over time.
Time Frame
Minimum 2 years (670-1033 days after surgery)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject is male or female and between the ages of 22 and 80 years at the time of surgery, inclusive.
Subject was diagnosed with NIDJD.
Subject, in the opinion of the Investigator, is a suitable candidate for cementless primary TKA using the devices described in this CIP with either resurfaced or non-resurfaced patellae.
Subject that is willing to give voluntary, written informed consent to participate in this clinical investigation and authorize the transfer of his/her information to the Sponsor
Subject is currently not bedridden
Subject, in the opinion of the Investigator, is able to understand this clinical investigation and is willing and able to perform all study procedures and follow-up visits and co-operate with investigational procedures.
Subject is able to read, and comprehend the Informed Consent Document as well as complete the required PROs in either English or one of the available translations.
Exclusion Criteria:
The Subject is a woman who is pregnant or lactating.
Contralateral knee has already been enrolled in this study .
Subject had a contralateral amputation.
Previous partial knee replacement (unicompartmental, bicompartmental or patellofemoral joint replacement), patellectomy, high tibial osteotomy or primary TKA in affected knee.
Subject is currently diagnosed with radicular pain from the spine that radiates into the limb to receive TKA.
Subject has participated in a clinical investigation with an investigational product (drug or device) in the last three (3) months.
Subject is currently involved in any personal injury litigation, medical-legal or worker's compensation claims.
Subject, in the opinion of the Investigator, is a drug or alcohol abuser (in the last 5 years) or has a psychological disorder that could affect their ability to complete patient reported questionnaires or be compliant with follow-up requirements.
Subject was diagnosed and is taking prescription medications to treat a muscular disorder that limits mobility due to severe stiffness and pain such as fibromyalgia or polymyalgia.
Subject has a significant neurological or musculoskeletal disorder(s) or disease that may adversely affect gait or weight bearing (e.g., muscular dystrophy, multiple sclerosis, Charcot disease).
Subject is suffering from inflammatory arthritis (e.g., rheumatoid arthritis, juvenile rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus, etc.).
Subject has a medical condition with less than five (5) years life expectancy.
Uncontrolled gout
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sukhjeet Kaur
Organizational Affiliation
Sponsor GmbH
Official's Role
Study Director
Facility Information:
Facility Name
Colorado Joint Replacement
City
Denver
State/Province
Colorado
ZIP/Postal Code
80210
Country
United States
Facility Name
Florida Research Associates
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
New London Hospital
City
New London
State/Province
New Hampshire
ZIP/Postal Code
03257
Country
United States
Facility Name
Rothman Institute
City
Egg Harbor Township
State/Province
New Jersey
ZIP/Postal Code
08234
Country
United States
Facility Name
SUNY downstate Medical Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Facility Name
UNC Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Associated Orthopaedics of Kingsport
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Facility Name
Texas Tech University Heath Science Center
City
Lubbock
State/Province
Texas
ZIP/Postal Code
49416
Country
United States
Facility Name
Hampton Roads Orthopaedics and Sports Medicine
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23606
Country
United States
Facility Name
Krankenhaus der Barmherzigen Schwestern Ried im Innkreis
City
Ried im Innkreis
State/Province
Upper Austria
ZIP/Postal Code
4910
Country
Austria
Facility Name
Foothills Medical Centre, University of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 2T9
Country
Canada
Facility Name
CHU de la Cavale Blanche
City
Brest
State/Province
Cedex
ZIP/Postal Code
29285
Country
France
Facility Name
Sevice de Chirurgie Orthoedique et Traumatologique
City
Salouel
ZIP/Postal Code
80480
Country
France
Facility Name
Klinikum Garmisch-Partenkirchen GmbH
City
Garmisch-Partenkirchen
ZIP/Postal Code
82467
Country
Germany
Facility Name
South Infirmary Victoria University Hospital
City
Cork
ZIP/Postal Code
T12 X23H
Country
Ireland
Facility Name
Elkerliek Ziekenhuis
City
Helmond
State/Province
Noord-Brabant
ZIP/Postal Code
5707 HA
Country
Netherlands
Facility Name
University of Otago
City
Christchurch
ZIP/Postal Code
8083
Country
New Zealand
Facility Name
Wrightington Hospital
City
Wigan
State/Province
Lancashire
ZIP/Postal Code
WN6 9EP
Country
United Kingdom
Facility Name
Nottingham University Hospitals NHS Trust
City
Nottingham
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
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14022 ATTUNE Cementless RP Clinical Performance Evaluation
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