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Evaluation of Post-Operative Recovery in ATTUNE® Total Knee Arthroplasty

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ClinicalTrials.gov Identifier: NCT02339610
Recruitment Status : Completed
First Posted : January 15, 2015
Last Update Posted : August 28, 2019
Sponsor:
Information provided by (Responsible Party):
DePuy Orthopaedics

Brief Summary:
This post-marketing investigation will evaluate the rate of recovery of the ATTUNE knee from the time of surgery through the 6 month endpoint in patients with severely painful and/or severely disabling Non-inflammatory Degenerative Joint Disease (NIDJD).

Condition or disease Intervention/treatment
Non-inflammatory Degenerative Joint Disease Device: ATTUNE Primary, Cemented Total Knee Replacement

Detailed Description:

This study is designed as a prospective, multi-center, non-randomized, non-comparative, non-controlled study. A sample size of N=200 subjects will be implanted at up to 4 sites in the Netherlands. Each site is expected to implant approximately 50 Subjects (50 knees).

This study allows the participating surgeon to choose the type of ATTUNE implant they would ordinarily use in standard practice. Both resurfaced patellae and non-resurfaced patellae are permitted in this investigation; consistent with the surgeons standard of care.

Subjects will receive one of four available implants: cruciate retaining fixed bearing (CR FB), cruciate retaining rotating platform (CR RP), posterior stabilized fixed bearing (PS FB), and posterior stabilized rotating platform (PS RP).

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Study Type : Observational
Actual Enrollment : 200 participants
Official Title: Multi-Center Evaluation of Post-Operative Recovery in ATTUNE Primary, Cemented Total Knee Arthroplasty
Actual Study Start Date : January 1, 2015
Actual Primary Completion Date : June 28, 2019
Actual Study Completion Date : June 28, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
ATTUNE Primary, Cemented Total Knee Replacement

Subjects will receive one of four available ATTUNE total knee implants:

(CR FB, CR RP, PS FB, PS RP).

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




Primary Outcome Measures :
  1. KOOS-PS change from baseline at 6 months post-operatively, as estimated from a repeated measurements longitudinal model over all post-operative time points. [ Time Frame: 6 Months Post-Operative minus Pre-Op ]

    The Knee Injury and Osteoarthritis Physical Function Short Form (KOOS-PS) will be used to measure knee function as a means of evaluating the rate of recovery.

    The (KOOS-PS) is a patient self-administered questionnaire. The questionnaire consists of 7 questions to evaluate function with activities of daily living (ADL) and higher level functioning activities (sport and recreational). Each question has 5 Likert-like response options.

    Scoring is a 0-100 point scale with 100 points considered best.



Secondary Outcome Measures :
  1. KOOS-PS change from baseline of the ATTUNE knee [ Time Frame: Pre-Op (-90 days to day of surgery), 6 weeks (1 - 60 days), 3 months (61 - 137 days), 1 year (304 - 669 days), and 2 years (670 - 913 days) post-operative ]

    The Knee Injury and Osteoarthritis Physical Function Short Form (KOOS-PS) will be used to measure knee function as a means of evaluating the rate of recovery.

    The (KOOS-PS) is a patient self-administered questionnaire. The questionnaire consists of 7 questions to evaluate function with activities of daily living (ADL) and higher level functioning activities (sport and recreational). Each question has 5 Likert-like response options.

    Scoring is a 0-100 point scale with 100 points considered best.


  2. Length of Hospital Stay [ Time Frame: Immediate-post-operative: average 1 week ]
    Collect days of hospitalization related to TKA procedure

  3. Annual Survivorship [ Time Frame: 1 year (304 - 669 days), 2 years (670 - 913 days) post-operative ]
    A Kaplan-Meier survival analysis will be used to calculate the survivorship of the ATTUNE implant.

  4. Type and frequency of Adverse Events (AEs) for all enrolled subjects [ Time Frame: Day 0 - Post-Operative Day 913 ]
    All Serious AEs must be reported to the Sponsor per protocol. All device-related and/or procedure-related AEs must be reported to the Sponsor per protocol.



Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 Non-inflammatory Degenerative Joint Disease (NIDJD).
  • Subject is a suitable candidate for cemented primary total knee replacement (TKA) using the devices described in this protocol 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 the study 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 speak, read, and comprehend the Informed Consent Document as well as complete the Patient Reported Outcomes Questionnaires required per the protocol in either Dutch or English translations.

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 that radiates into the limb to receive TKA.
  • Subject has participated in a clinical investigation with an investigational product (drug or device) in the last three months.
  • Subject is currently involved in any personal injury litigation, medical-legal or worker's compensation claims.
  • 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 questionnaires 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 3 years of life expectancy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02339610


Locations
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Netherlands
Rijnstate Hospital - Orthopaedic Department
Arnhem, Gelderland, Netherlands, 6800
Lievensberg Hospital Orthopaedic Department
Bergen op Zoom, North Brabant, Netherlands, 4624
Spaarne Hospital Orthopaedic Department
Hoofddorp, North Holland, Netherlands, 2134
HAGA Hospital Orthopaedic Department
The Hague, South Holland, Netherlands, 2566
Sponsors and Collaborators
DePuy Orthopaedics
Investigators
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Study Director: Verdonna Huey, MS, BSN, CCRP DePuy Orthopaedics
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: DePuy Orthopaedics
ClinicalTrials.gov Identifier: NCT02339610    
Other Study ID Numbers: 13005
First Posted: January 15, 2015    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: August 2019
Keywords provided by DePuy Orthopaedics:
Osteoarthritis
Post-traumatic Arthritis
Additional relevant MeSH terms:
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Joint Diseases
Osteoarthritis
Musculoskeletal Diseases
Arthritis
Rheumatic Diseases