NCT03193034

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 19, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 20, 2017

Completed
10 days until next milestone

Study Start

First participant enrolled

June 30, 2017

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 22, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

September 29, 2021

Status Verified

September 1, 2021

Enrollment Period

3.5 years

First QC Date

June 19, 2017

Last Update Submit

September 28, 2021

Conditions

Osteoarthritis

Keywords

ArthroplastyreplacementKneefunctionradiographicsurvivorship

Outcome Measures

Primary Outcomes (1)

  • 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.

    Minimum 2 years (670-912 days after surgery)

Secondary Outcomes (10)

  • Patient-reported Outcome: Pre-surgical/Post-surgical Patient's Knee Implant Performance (PKIP)

    Minimum 2 years (670-912 days after surgery)

  • Patient-reported Outcome: Knee Injury and Osteoarthritis Outcome Score (KOOS)

    Minimum 2 years (670-912 days after surgery)

  • Combination of Patient-reported and Clinical-reported Outcome: Knee Society 2011

    Minimum 2 years (670-912 days after surgery)

  • Patient Reported Outcome: EuroQol 5D 3L questionnaire (EQ-5D-3L)

    Minimum 2 years (670-912 days after surgery)

  • Modified VAS Pain Score: Pain and Satisfaction

    Minimum 2 years (670-912 days after surgery)

  • +5 more secondary outcomes

Study Arms (1)

ATTUNE Cementless RP TKA

EXPERIMENTAL

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

Device: Cementless Total Knee Arthroplasty

Interventions

Cementless Total Knee ArthroplastyDEVICE

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

ATTUNE Cementless RP TKA

Eligibility Criteria

Age22 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Nagoya orthopedic Clinic

Kitanagoya, Aichi-ken, 481-0011, Japan

Location

Nagoya City University Hospital

Nagoya, Aichi-ken, 467-8601, Japan

Location

Kobe University Graduate School of Medicine

Kobe, Hyōgo, 650-0017, Japan

Location

Osaka Rosai Hospital

Sakai, Osaka, 591-8025, Japan

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Kirstin Cosgrove

    Sponsor GmbH

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
An independent radiographic reviewer will be assessing all radiographs from the study.
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2017

First Posted

June 20, 2017

Study Start

June 30, 2017

Primary Completion

December 22, 2020

Study Completion

June 30, 2021

Last Updated

September 29, 2021

Record last verified: 2021-09

Locations

JP(4)