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Evaluation of Post-Operative Recovery in ATTUNE® Total Knee Arthroplasty | Clinical Trials | Clareo Health

COMPLETED

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

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

NCT02339610•DePuy Orthopaedics

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).

Eligibility

Age

22 - 80 years

Sex

ALL

Healthy Volunteers

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).
+2 more criteria

Locations (4)

Rijnstate Hospital - Orthopaedic Department

Arnhem, Gelderland, Netherlands

Lievensberg Hospital Orthopaedic Department

Bergen op Zoom, North Brabant, Netherlands

Spaarne Hospital Orthopaedic Department

Hoofddorp, North Holland, Netherlands

HAGA Hospital Orthopaedic Department

The Hague, South Holland, Netherlands

Key Dates

Start Date

January 1, 2015

Primary Completion Date

June 28, 2019

Completion Date

June 28, 2019

Last Updated

August 28, 2019

Enrollment

200

ACTUAL participants

Conditions

Non-inflammatory Degenerative Joint Disease

Interventions

ATTUNE Primary, Cemented Total Knee Replacement

DEVICE

PMCF Study on the Safety, Performance and Clinical Benefits Data of the NexGen TM Augmentation Patella

NCT05253976

Rheumatoid ArthritisNon-inflammatory Degenerative Joint Disease+2 more

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COMPLETEDNA

Metal Ion Release From an FDA-Approved Metal-on-Metal Total Hip Replacement Implant

NCT00962351

Non-inflammatory Degenerative Joint Disease

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 28, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

PMCF Study on the Safety, Performance and Clinical Benefits Data of the NexGen TM Augmentation Patella

Metal Ion Release From an FDA-Approved Metal-on-Metal Total Hip Replacement Implant

CoMplete™ Acetabular Hip System