ATTUNE Revision System in the Revision Total Knee Arthroplasty Population

DePuy Synthes

Status: Active, not recruiting

Conditions: Revision Total Knee Arthroplasty

Treatments: Device: ATTUNE Revision Knee System in Revision Total Knee Arthroplasty

Study type: Interventional

Funder types: Industry

Identifiers

NCT03153475

DSJ-2016-02

Details and patient eligibility

About

Five-year, Prospective, multi-center, non-randomized, non-controlled study of the ATTUNE® Revision total knee prostheses, utilizing the fixed bearing (FB) and rotating platform (RP) tibial component with the posterior stabilizing (PS) femoral component in revision total knee arthroplasty.

Full description

The study is designed as a non-comparative, worldwide, multi-center study with up to 30 sites that will intend to implant a total of 400 Subjects (200 PS RP and 200 PS FB) with the study devices. The follow-up period of 5 years was selected to cover both the early post-operative period as well as the medium term period which is a good indicator of longer term survivorship.

The primary endpoint of survivorship at 5 years was selected to capture the time period during which the majority of revision failures occur while providing a good indication of long term survivorship. The secondary outcomes include commonly used measures of clinical performance that will allow for comparison with published literature. Additionally, patient reported outcomes, AORI bone defect classification , satisfaction and pain scores will be collected and analyzed.

Male and female Subjects, age 22-80 years, inclusive, with a failed primary knee arthroplasty, including unicompartmental or failed previous revision TKA, who are suitable candidates for revision TKA using the ATTUNE® Revision system are eligible for enrollment in this study. The use of the ATTUNE Revision system includes both partial and complete revision surgical procedures, including implantation of revision components as the second stage within a two-stage treatment for infection.

Enrollment: 400 patients

Sex: All

Ages: 22 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

1. Subject is male or female and between the ages of 22 and 80 years at the time of consent, inclusive.
2. Subject presents with a primary knee arthroplasty (primary TKA, unicompartmental) or prior revision TKA that requires a revision procedure of implanted tibial and/or femoral components.
3. The decision to perform a knee revision with the study device is regardless of the research.
4. Subject that is willing to give voluntary, written informed consent to participate in this clinical investigation and authorize the transfer of his/her information to the Sponsor
5. Subject is currently not bedridden
6. The devices are to be used according to the approved indications.Subject is able to read, and comprehend the Informed Consent Document as well as complete the required PROMs in either English or one of the available translations.

Exclusion Criteria:

1. The Subject is a woman who is pregnant or lactating.
2. Contralateral knee has already been enrolled in this study.
3. Subject had a contralateral amputation.
4. Subject is currently diagnosed with radicular pain from the spine that radiates into the limb to receive RTKA.
5. Subject has participated in a clinical investigation with an investigational product (drug or device) in the last three (3) months.
6. Subject is currently involved in any personal injury litigation, medical-legal or worker's compensation claims.
7. 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 his/her ability to complete patient reported questionnaires or be compliant with follow-up requirements.
8. 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.
9. Subject has a significant neurological or musculoskeletal disorder(s) or disease that may adversely affect gait or weight bearing activities (e.g., muscular dystrophy, multiple sclerosis, Charcot disease).
10. Subject has a medical condition with less than five (5) years life expectancy as determined by the Investigator.
11. Uncontrolled gout

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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400 participants in 1 patient group

ATTUNE Revision Knee System

Other group

Description:

The ATTUNE Revision system is complementary to the ATTUNE primary knee portfolio and includes both rotating platform (RP) and fixed bearing (FB) configurations. The system includes a full compliment of implants designed to address the challenges faced in revision knee surgeries. These implants include Stemmable tibial and femoral components, augments, sleeves and offsets

Treatment:

Device: ATTUNE Revision Knee System in Revision Total Knee Arthroplasty