Clinical trial NCT03193034: 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
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Keywords: Arthroplasty
replacement
Knee
function
radiographic
survivorship
Lead sponsor: DePuy Orthopaedics
Sponsor class: INDUSTRY
Collaborators: name: Johnson & Johnson K.K. Medical Company
First posted: 2017-06-20
Enrollment: 81
Sex: ALL
Minimum age (years): 22
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Patient-reported Outcome:Knee Injury and Osteoarthritis Outcome Score Activities of Daily Living (KOOS ADL)
timeFrame: Minimum 2 years (670-912 days after surgery)
Secondary outcomes:
measure: Patient-reported Outcome: Pre-surgical/Post-surgical Patient's Knee Implant Performance (PKIP)
timeFrame: Minimum 2 years (670-912 days after surgery)
measure: Patient-reported Outcome: Knee Injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: Minimum 2 years (670-912 days after surgery)
measure: Combination of Patient-reported and Clinical-reported Outcome: Knee Society 2011
timeFrame: Minimum 2 years (670-912 days after surgery)
measure: Patient Reported Outcome: EuroQol 5D 3L questionnaire (EQ-5D-3L)
timeFrame: Minimum 2 years (670-912 days after surgery)
measure: Modified VAS Pain Score: Pain and Satisfaction
timeFrame: Minimum 2 years (670-912 days after surgery)
measure: Type and Frequency of Adverse Events (AEs) for all enrolled subjects
timeFrame: 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)
measure: Survivorship
timeFrame: Minimum 1 year (304-669 days after surgery), minimum 2 years (670-912 days after surgery)
measure: Implant fixation: Radiographic assessment of bone-implant interface performance
timeFrame: 6 weeks (1-303 days after surgery), minimum 1 year (304-669 days after surgery), minimum 2 years (670-912 days after surgery)
measure: Evaluate changes in femoral component and tibial component alignment
timeFrame: Minimum 2 years (670-912 days after surgery)
measure: Radiographically characterize the postoperative ATTUNE patellar component alignment and positioning in Japanese population.
timeFrame: Minimum 1 year (304-669 days after surgery)
Other outcomes:
Locations:
city: Kitanagoya
country: Japan
facility: Nagoya orthopedic Clinic
state: Aichi
city: Nagoya
country: Japan
facility: Nagoya City University Hospital
state: Aichi
city: Kobe
country: Japan
facility: Kobe University Graduate School of Medicine
state: Hyogo
city: Sakai
country: Japan
facility: Osaka Rosai Hospital
state: Osaka
Study officials:
affiliation: Sponsor GmbH
name: Kirstin Cosgrove
role: STUDY_DIRECTOR
References: