Prospective, Multiconfiguration Study to Assess Functional Performance of Primary Total Knee Arthroplasty System (10004)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by DePuy Orthopaedics
Sponsor:
Information provided by (Responsible Party):
DePuy Orthopaedics
ClinicalTrials.gov Identifier:
NCT01746524
First received: December 5, 2012
Last updated: July 22, 2014
Last verified: July 2014
  Purpose

This post-marketing investigation will evaluate the functional knee performance of Subjects who have undergone primary total knee arthroplasty (TKA). Data from Subjects who receive one of four contemporary knee configurations will be pooled to establish a contemporary dataset.

The primary objective of this study is to evaluate the pre-operative (approximately -90 to -1 day before surgery) to minimum one year (approximately 304 to 668 days) postoperative functional performance improvement for the Attune™ primary, cemented TKA system as measured by the activities of daily living (ADL)subscore of the Knee Osteoarthritis Outcomes Score (KOOS)questionnaire (KOOS-ADL sub-score). This will be carried out for all four implant configurations: cruciate retaining fixed bearing (Attune™ CR FB), cruciate retaining rotating platform (Attune™ CR RP), posterior stabilized fixed bearing (Attune™ PS FB), and posterior stabilized rotating platform (Attune™ PS RP).


Condition Intervention
Osteoarthritis
Device: ATTUNE Primary Total Knee Arthroplasty

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective, Single Arm Multiconfiguration Investigation to Assess Functional Performance of Attune™ Primary Total Knee Arthroplasty System

Resource links provided by NLM:


Further study details as provided by DePuy Orthopaedics:

Primary Outcome Measures:
  • Knee Injury and Osteoarthritis Outcome Score (KOOS) activities of daily living (ADL) sub-score change from baseline. [ Time Frame: One year or later (approximately 304 days or later) ] [ Designated as safety issue: No ]
    The KOOS ADL will be measured before surgery and at a minimum 1 year after surgery. The KOOS is a patient self-administered questionnaire that consists of 42 questions. 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. The change from baseline is the minimum 1 year (approximately 304 to 668 days) measurement minus the baseline measurement.


Secondary Outcome Measures:
  • Patient Reported Outcome: Oxford Knee Score (OKS) [ Time Frame: Pre-op (-90 to -1 days before surgery), < 1 year (1 to 303 days), minimum 1 year (304 to 668 days), minimum 2 year (669 to 1763 days) ] [ Designated as safety issue: No ]
    The Oxford Knee Score (OKS) is a patient self-administered 12-item questionnaire with each question having 5 Likert- like response option. Each item is scored from 0 to 4, and the items are summated, with lower total scores indicating poorer performance. The OKS measures pain and general activities of daily living.

  • Patient Reported Outcome: Pre-surgical/Post-surgical Patient's Knee Implant Performance (PKIP) [ Time Frame: Pre-op (-90 to -1 days before surgery), < 1 year (1 to 303 days), minimum 1 year (304 to 668 days), minimum 2 year (669 to 1763 days) ] [ Designated as safety issue: No ]
    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 Report Outcome: EuroQol 5D 3L questionnaire (EQ-5D-3L) [ Time Frame: Pre-op (-90 to -1 days before surgery), < 1 year (1 to 303 days), minimum 1 year (304 to 668 days), minimum 2 year (669 to 1763 days) ] [ Designated as safety issue: No ]
    EuroQol 5D 3L questionnaire is a standardized instrument for use as a measure of health outcome that is designed for completion by the subject.

  • Type and Frequency of Adverse Events (AEs) for all enrolled subjects [ Time Frame: < 1 year (1 to 303 days), minimum 1 year (304 to 668 days), minimum 2 year (669 to 1763 days) ] [ Designated as safety issue: Yes ]
    All Serious AEs must be reported to Sponsor. All device-related or procedure-related adverse events must be reported to Sponsor.

  • Evaluate primary cemented fixation through zonal radiographic analysis post-operatively [ Time Frame: minimum 1 year (304 to 668 days), minimum 2 year (669 to 1763 days) ] [ Designated as safety issue: No ]
    Radiographs will be reviewed by an independent radiographic reviewer (IRR). Data from the IRR radiographic evaluations will be used for determination of radiographic success criteria.

  • Incidence of post-operative anterior knee pain and symptomatic/asymptomatic crepitus [ Time Frame: Pre-op (-90 to -1 days before surgery), < 1 year (1 to 303 days), minimum 1 year (304 to 668 days), minimum 2 year (669 to 1763 days) ] [ Designated as safety issue: No ]
    The Anterior Knee Pain and Crepitus questionnaire will be used. It is a 2 part questionnaire that is patient-self administered. The crepitus questions include frequency of crepitus and whether or not crepitus is symptomatic. The anterior knee pain contains 2 questions that collect frequency of pain and location of pain.

  • Evaluate surgeon learning curve on clinical and functional outcomes [ Time Frame: < 1 year (1 to 303 days), minimum 1 year (304 to 668 days), minimum 2 year (669 to 1763 days) ] [ Designated as safety issue: No ]
    Each surgeon will implant devices into the first 10 Subjects which will be considered as 'learning curve cases'; these learning curve cases will not be pooled with post-learning curve cases unless learning curve analyses indicate that there is not a significant learning curve with regard to clinical or functional Subject outcomes.

  • Evaluate the impact of ligament balancing surgical technique on functional performance [ Time Frame: Operatively (Day 0 - Date of Surgery) ] [ Designated as safety issue: No ]
    Description of the Subject's surgical procedure including such items as surgical approach and ligament balancing will be evaluated.

  • Psychometric Properties of the Patient Knee Implant Performance (PKIP)questionnaire [ Time Frame: Pre-op (-90 to -1 days before surgery), < 1 year (1 to 303 days), minimum 1 year (304 to 668 days), minimum 2 year (669 to 1763 days) ] [ Designated as safety issue: No ]
    The Pre and 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.

  • Evaluate the functional outcome of patella resurfacing and non-resurfacing [ Time Frame: < 1 year (1 to 303 days), minimum 1 year (304 to 668 days), minimum 2 year (669 to 1763 days) ] [ Designated as safety issue: No ]
    An exploratory comparison of results between knees with patella resurfacing versus knees without resurfacing will be conducted. A comparison of KOOS, PKIP, OKS, Knee Society (AKS), anterior knee pain incidence, and crepitus will be conducted.

  • Evaluate changes in femoral component and tibial component alignment [ Time Frame: < 1 year (1 to 303 days), minimum 1 year (304 to 668 days), minimum 2 year (669 to 1763 days) ] [ Designated as safety issue: No ]
    Radiographs will be reviewed by an independent radiographic reviewer (IRR) in order to minimize bias of radiographic outcomes. Data from the IRR radiographic evaluations will be used to evaluate femoral and tibial component alignment over time.


Estimated Enrollment: 1040
Study Start Date: November 2012
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ATTUNE Primary Total Knee Arthroplasty

Subjects will receive one of the following total knee configurations:

Cruciate Retaining Fixed Bearing (CR FB) Posterior Stabilized Fixed Bearing (PS FB) Cruciate Retaining Rotating Platform (CR RP) Posterior Stabilized Rotating Platform (PS RP)

Device: ATTUNE Primary Total Knee Arthroplasty
Patients will undergo a primary, cemented total knee replacement using one of the four configurations of the Attune knee (CR FB, PS FB, CR RP, PS RP).

Detailed Description:

The study is designed as a prospective, single arm stratified, multi-center investigation.

Approximately 20 study sites, worldwide, will enroll 1040 subjects (1040 knees). Each study is expected to enroll approximately 52 subjects (approximately 52 knees). An additional 10 subjects per site may be recruited at sites which have Sub-Investigators participating in the study. Cohort reallocation is permitted. There will be no control group. One thousand and forty (1040)Subjects will be stratified into 4 subgroups of 260: cruciate retaining fixed bearing(CR FB), posterior stabilized fixed bearing (PS FB), cruciate retaining rotating platform (CR RP), and posterior stabilized rotating platform (PS RP). Treatment assignment in this study is not randomized.

Each site will only enroll patients in one of the four knee configuration sub-groups most commonly used as their standard of care.

  Eligibility

Ages Eligible for Study:   22 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject is male or female and between the ages of 22 and 80 years, inclusive.
  • Subject was diagnosed with NIDJD.
  • Subject is a suitable candidate for cemented primary TKA using the devices described in the Clinical Investigation Plan (CIP)with either resurfaced or non-resurfaced patellae.
  • Subject has given voluntary, written informed consent to participate in this clinical investigation and has authorized the transfer of his/her information to DePuy.
  • Subject is currently not bedridden.
  • Subject, in the opinion of the Clinical Investigator, is able to understand this clinical investigation and co-operate with investigational procedures.
  • Subject must be comfortable with speaking, reading, and understanding questions and providing responses in an available translated language for the PROs in the CIP.
  • The devices specified in this CIP were implanted.

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 experiencing radicular pain from the spine.
  • Subject has participated in an IDE/IND clinical investigation with an investigational product in the last three months.
  • Subject is currently involved in any personal injury litigation, medical-legal or worker's compensation claims.
  • Subject is a known drug or alcohol abuser or has a psychological disorder that could affect their ability to complete patient reported questionnaires.
  • Subject was diagnosed with fibromyalgia that is currently being treated with prescription medication.
  • Subject has significant neurological or musculoskeletal disorders 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 is not comfortable with speaking, reading, and understanding questions and providing responses in an available translated language for the PROs in the CIP.
  • Subject has a medical condition with less than 2 years of life expectancy.
  Contacts and Locations
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: NCT01746524

Contacts
Contact: Sam Himden, BA 574-372-7231 shimden@its.jnj.com

Locations
United States, California
Orthopaedic Specialty Institute Recruiting
Orange, California, United States, 92868
UCSD Medical Center Not yet recruiting
San Diego, California, United States, 92103
United States, Colorado
Orhopaedic Center of the Rockies Recruiting
Ft. Collins, Colorado, United States, 80525
United States, Kentucky
The Arthroplasty Foundation Active, not recruiting
Louisville, Kentucky, United States, 40215
United States, Nevada
Hip and Knee Research of Nevada Recruiting
Las Vegas, Nevada, United States, 89128
United States, New Hampshire
Dartmouth Medical School/Dartmouth-Hitchcock Medical Center Recruiting
Lebanon, New Hampshire, United States, 03765
United States, Ohio
Cardinal Orthopaedic Institute Recruiting
Columbus, Ohio, United States, 43213
United States, Virginia
Anderson Orthopaedic Research Institute Recruiting
Alexandria, Virginia, United States, 22307
United States, Washington
Swedish Orthopedic Institute Recruiting
Seattle, Washington, United States, 98122
Australia, New South Wales
Sutherland Hospital Recruiting
Caringbah, New South Wales, Australia, 2229
Hornsby Ku-ring-gai Hospital Not yet recruiting
Hornsby, New South Wales, Australia, 2077
Australia, South Australia
Wakefield Orthopaedic Clinic Recruiting
Adelaide, South Australia, Australia, 5000
Australia, Western Australia
Freemantle Hospital Recruiting
Crawley, Western Australia, Australia, 6009
New Zealand
Ascot Hospital Recruiting
Aukland, New Zealand
United Kingdom
Queen Margaret Hospital Active, not recruiting
Dunfermline, Fife, United Kingdom, KY12 OSU
Princess Alexandra Hospital Recruiting
Essex, Harlow, United Kingdom, CM20 1QX
The Royal Surrey County Hospital Recruiting
Guildford, Surrey, United Kingdom, GU2 7XX
University Hospital Llandough Recruiting
Llandough, United Kingdom, CF64 2XX
James Cook University Hospital Recruiting
Middlesborough, United Kingdom, TS4 3BW
Clifton Park NHS Treatment Centre Recruiting
York, United Kingdom, YO30 5RA
Sponsors and Collaborators
DePuy Orthopaedics
Investigators
Study Director: Sam Himden, BA DePuy Orthopaedics
  More Information

No publications provided

Responsible Party: DePuy Orthopaedics
ClinicalTrials.gov Identifier: NCT01746524     History of Changes
Other Study ID Numbers: 10004
Study First Received: December 5, 2012
Last Updated: July 22, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by DePuy Orthopaedics:
Arthroplasty
Replacement
Knee

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on July 22, 2014