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

Multi-Center Evaluation of Post-Operative Recovery in ATTUNE Primary, Cemented Total Knee Arthroplasty

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).

Study Overview

• Status: Completed
• Conditions: Non-inflammatory Degenerative Joint Disease
• Intervention / Treatment: 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).

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• Netherlands
  • Gelderland
    • Arnhem, Gelderland, Netherlands, 6800
      • Rijnstate Hospital - Orthopaedic Department
  • North Brabant
    • Bergen op Zoom, North Brabant, Netherlands, 4624
      • Lievensberg Hospital Orthopaedic Department
  • North Holland
    • Hoofddorp, North Holland, Netherlands, 2134
      • Spaarne Hospital Orthopaedic Department
  • South Holland
    • The Hague, South Holland, Netherlands, 2566
      • HAGA Hospital Orthopaedic Department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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).

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
KOOS-PS change from baseline of the ATTUNE knee	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.	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
Length of Hospital Stay	Collect days of hospitalization related to TKA procedure	Immediate-post-operative: average 1 week
Annual Survivorship	A Kaplan-Meier survival analysis will be used to calculate the survivorship of the ATTUNE implant.	1 year (304 - 669 days), 2 years (670 - 913 days) post-operative
Type and frequency of Adverse Events (AEs) for all enrolled subjects	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.	Day 0 - Post-Operative Day 913

Collaborators and Investigators

• Sponsor: DePuy Orthopaedics
• Investigators: Study Director: Verdonna Huey, MS, BSN, CCRP, DePuy Orthopaedics

Publications and helpful links

General Publications

• van Loon C, Baas N, Huey V, Lesko J, Meermans G, Vergroesen D. Early outcomes and predictors of patient satisfaction after TKA: a prospective study of 200 cases with a contemporary cemented rotating platform implant design. J Exp Orthop. 2021 Apr 17;8(1):30. doi: 10.1186/s40634-021-00347-w.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Actual): June 28, 2019
• Study Completion (Actual): June 28, 2019

Study Registration Dates

• First Submitted: November 21, 2014
• First Submitted That Met QC Criteria: January 12, 2015
• First Posted (Estimate): January 15, 2015

Study Record Updates

• Last Update Posted (Actual): August 28, 2019
• Last Update Submitted That Met QC Criteria: August 22, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Osteoarthritis; Post-traumatic Arthritis
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Joint Diseases
• Other Study ID Numbers: 13005