Back to resultsDSJ-2016-07 ATTUNE® Cementless CR RP Japan
Primary Purpose
Osteoarthritis
Status
Completed
Phase
Not Applicable
Locations
Japan
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 Japanese.
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 investig ation 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 Acc ident Insurance claims (similar to Workers Compensation in USA).
- 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 question naires 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 two (2) years life expectancy.
- Uncontrolled gout
Sites / Locations
- Nagoya orthopedic Clinic
- Nagoya City University Hospital
- Kobe University Graduate School of Medicine
- Osaka Rosai Hospital
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 configuration (CR 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.
Evaluate changes in femoral component and tibial component alignment
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.
Radiographically characterize the postoperative ATTUNE patellar component alignment and positioning in Japanese population.
Evaluate the tilt angle and translational position of the patellar component relative to the trochlear groove.
Full Information
NCT ID
NCT03193034
First Posted
June 19, 2017
Last Updated
September 28, 2021
Sponsor
DePuy Orthopaedics
Collaborators
Johnson & Johnson K.K. Medical Company
1. Study Identification
Unique Protocol Identification Number
NCT03193034
Brief Title
DSJ-2016-07 ATTUNE® Cementless CR RP Japan
Official Title
Multi-Center Clinical Evaluation of the ATTUNE® Cementless Rotating Platform Total Knee Arthroplasty in the Japanese Patient Population
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
June 30, 2017 (Actual)
Primary Completion Date
December 22, 2020 (Actual)
Study Completion Date
June 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
DePuy Orthopaedics
Collaborators
Johnson & Johnson K.K. Medical Company
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The primary objective is to investigate 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) in the Japanese patient population.
Detailed Description
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 configurations using Kaplan-Meier survival analysis at 1 and 2yrs.
Evaluate primary, cementless ATTUNE® TKA fixation through zonal radiographic analysis of the bone-implant interface at 6wk, 1yr, and 2yrs after surgery.
Evaluate any changes in anatomic tibiofemoral, femoral component and tibial component alignment at 2 years compared to the first postoperative radiographs.
Radiographically characterize the postoperative ATTUNE patellar component alignment and positioning in Japanese population.
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
81 (Actual)
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 the configuration of the ATTUNE Cementless knee (CR 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 (670-912 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 (670-912 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 (670-912 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 (670-912 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 (670-912 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 (670-912 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 (-180 to -1 days before surgery), 6 weeks (1-303 days after surgery), minimum 1 year (304-669 days after surgery), minimum 2 years (670-912 days after surgery)
Title
Survivorship
Description
Kaplan-Meier survival analysis will be used to calculate the survivorship of configuration (CR RP)
Time Frame
Minimum 1 year (304-669 days after surgery), minimum 2 years (670-912 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 (1-303 days after surgery), minimum 1 year (304-669 days after surgery), minimum 2 years (670-912 days after surgery)
Title
Evaluate changes in femoral component and tibial component alignment
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 (670-912 days after surgery)
Title
Radiographically characterize the postoperative ATTUNE patellar component alignment and positioning in Japanese population.
Description
Evaluate the tilt angle and translational position of the patellar component relative to the trochlear groove.
Time Frame
Minimum 1 year (304-669 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 Japanese.
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 investig ation 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 Acc ident Insurance claims (similar to Workers Compensation in USA).
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 question naires 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 two (2) years life expectancy.
Uncontrolled gout
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kirstin Cosgrove
Organizational Affiliation
Sponsor GmbH
Official's Role
Study Director
Facility Information:
Facility Name
Nagoya orthopedic Clinic
City
Kitanagoya
State/Province
Aichi
ZIP/Postal Code
481-0011
Country
Japan
Facility Name
Nagoya City University Hospital
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
467-8601
Country
Japan
Facility Name
Kobe University Graduate School of Medicine
City
Kobe
State/Province
Hyogo
ZIP/Postal Code
650-0017
Country
Japan
Facility Name
Osaka Rosai Hospital
City
Sakai
State/Province
Osaka
ZIP/Postal Code
591-8025
Country
Japan
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
DSJ-2016-07 ATTUNE® Cementless CR RP Japan
We'll reach out to this number within 24 hrs