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

Completed

• Conditions: Non-inflammatory Degenerative Joint Disease
• Interventions: Device: ATTUNE Primary, Cemented Total Knee Replacement

• Registration Number: NCT02339610
• Lead Sponsor: 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).

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 Timeline

• Study First Submitted: 2014-11-21
• Study Start: 2015-01-01
• Study First Submitted QC: 2015-01-12
• Study First Posted: 2015-01-15
• Primary Completion: 2019-06-28
• Study Completion: 2019-06-28
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-22
• Last Update Posted: 2019-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ATTUNE Primary, Cemented Total Knee Replacement	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).

Primary Outcome Measures

Name	Time	Method
KOOS-PS change from baseline at 6 months post-operatively, as estimated from a repeated measurements longitudinal model over all post-operative time points.	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

Name	Time	Method
Length of Hospital Stay	Immediate-post-operative: average 1 week	Collect days of hospitalization related to TKA procedure
KOOS-PS change from baseline of the ATTUNE knee	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.
Type and frequency of Adverse Events (AEs) for all enrolled subjects	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.
Annual Survivorship	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.

Trial Locations

Locations (4)

Rijnstate Hospital - Orthopaedic Department; 🇳🇱 Arnhem, Gelderland, Netherlands

HAGA Hospital Orthopaedic Department; 🇳🇱 The Hague, South Holland, Netherlands

Spaarne Hospital Orthopaedic Department; 🇳🇱 Hoofddorp, North Holland, Netherlands

Lievensberg Hospital Orthopaedic Department; 🇳🇱 Bergen op Zoom, North Brabant, Netherlands