DSJ-2016-07 ATTUNE® Cementless CR RP Japan

NCT ID: NCT03193034

Last Updated: 2021-09-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 81 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-30
• Study Completion Date: 2021-06-30

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.

Conditions

Osteoarthritis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ATTUNE Cementless RP TKA

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

Group Type: EXPERIMENTAL

Cementless Total Knee Arthroplasty

Intervention Type: DEVICE

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

Interventions

Cementless Total Knee Arthroplasty

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 22 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johnson & Johnson K.K. Medical Company

INDUSTRY

Sponsor Role: collaborator

DePuy Orthopaedics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kirstin Cosgrove

Role: STUDY_DIRECTOR

Sponsor GmbH

Locations

Nagoya orthopedic Clinic

Kitanagoya, Aichi-ken, Japan

Nagoya City University Hospital

Nagoya, Aichi-ken, Japan

Kobe University Graduate School of Medicine

Kobe, Hyōgo, Japan

Osaka Rosai Hospital

Sakai, Osaka, Japan

Countries

Japan

Other Identifiers

DSJ-2016-07

Identifier Type: -

Identifier Source: org_study_id