DSJ-2016-07 ATTUNE® Cementless CR RP Japan


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Verified June 2017 by DePuy Orthopaedics

Sponsor:

Collaborator:

Johnson & Johnson K.K. Medical Company

Information provided by (Responsible Party):

DePuy Orthopaedics

ClinicalTrials.gov Identifier:

NCT03193034

First received: June 19, 2017

Last updated: June 19, 2017

Last verified: June 2017

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.

Osteoarthritis Device: Cementless Total Knee Arthroplasty Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Masking Description:

An independent radiographic reviewer will be assessing all radiographs from the study.

Primary Purpose: Treatment

Official Title: Multi-Center Clinical Evaluation of the ATTUNE® Cementless Rotating Platform Total Knee Arthroplasty in the Japanese Patient Population

Primary Outcome Measures:

  • Patient-reported Outcome:Knee Injury and Osteoarthritis Outcome Score Activities of Daily Living (KOOS ADL) [ Time Frame: Minimum 2 years (670-912 days after surgery) ]

    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) [ Time Frame: Minimum 2 years (670-912 days after surgery) ]

    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) [ Time Frame: Minimum 2 years (670-912 days after surgery) ]

    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 [ Time Frame: Minimum 2 years (670-912 days after surgery) ]

    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) [ Time Frame: Minimum 2 years (670-912 days after surgery) ]

    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 [ Time Frame: Minimum 2 years (670-912 days after surgery) ]

    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 [ 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) ]

    All Serious AEs must be reported to Sponsor. All device-related or procedure-related adverse events must be reported to Sponsor.

  • Survivorship [ Time Frame: Minimum 1 year (304-669 days after surgery), minimum 2 years (670-912 days after surgery) ]

    Kaplan-Meier survival analysis will be used to calculate the survivorship of configuration (CR RP)

  • Implant fixation: Radiographic assessment of bone-implant interface performance [ 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) ]

    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 [ Time Frame: Minimum 2 years (670-912 days after surgery) ]

    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. [ Time Frame: Minimum 1 year (304-669 days after surgery) ]

Estimated Enrollment: 80
Anticipated Study Start Date: June 26, 2017
Estimated Study Completion Date: May 31, 2020
Estimated Primary Completion Date: May 31, 2020 (Final data collection date for primary outcome measure)
Experimental: ATTUNE Cementless RP TKA

Subjects will receive a cementless, rotating platform total knee arthroplasty.

Device: Cementless Total Knee Arthroplasty

Patients will undergo a primary total knee replacement using the configuration of the ATTUNE Cementless knee (CR RP)

  • 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.

Ages Eligible for Study:   22 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03193034

Nagoya orthopedic Clinic
Kitanagoya, Aichi, Japan, 481-0011
Contact: Hideki Warashina    +81-568-22-7772    h.warashina@gmail.com   
Principal Investigator: Hideki Warashina         
Nagoya City University Hospital
Nagoya, Aichi, Japan, 467-8601
Contact: Masahiro Nozaki    +81-52-853-8236    mnozaki@med.nagoya-cu.ac.jp   
Principal Investigator: Masahiro Nozaki         
Kobe University Graduate School of Medicine
Kobe, Hyogo, Japan, 650-0017
Contact: Tomoyuki Matsumoto    +81-78-382-5985    matsunt@med.kobe-u.ac.jp   
Principal Investigator: Tomoyuki Matsumoto         
Osaka Rosai Hospital
Sakai, Osaka, Japan, 591-8025
Contact: Shigeru Nakagawa    +81-72-252-3561    shigerun@qc5.so-net.ne.jp   
Principal Investigator: Shigeru Nakagawa         

DePuy Orthopaedics

Johnson & Johnson K.K. Medical Company

Study Director: Sue Kemp, B.Sc., Ph.D. Sponsor GmbH

Responsible Party: DePuy Orthopaedics
ClinicalTrials.gov Identifier: NCT03193034     History of Changes
Other Study ID Numbers: DSJ-2016-07
Study First Received: June 19, 2017
Last Updated: June 19, 2017
Individual Participant Data  
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by DePuy Orthopaedics:

Arthroplasty
replacement
Knee
function
radiographic
survivorship

Additional relevant MeSH terms:

Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on June 20, 2017