Noninflammatory Degenerative Joint Di...

Survivorship of Attune Primary Total Knee Prosthesis

About this trial

Last updated 2 months ago

Study ID

10008

Status

Active not recruiting

Type

Interventional

Phase

N/A

Placebo

Accepting

22 to 75 Years

All Sexes

Trial Timing

Started 13 years ago

What is this trial about?

This post-marketing investigation will evaluate the long term (up to 15 years) survivorship of the Attune Primary Knee Prosthesis in patients with non-inflammatory degenerative joint disease. Data from Subjects who receive one of four knee configurations will be pooled to establish a contemporary dataset.

What are the participation requirements?

Inclusion Criteria

* Subject is male or female and between the ages of 22 and 75 years at the time of surgery, inclusive.

* Subject was diagnosed with NIDJD.

* Subject is a suitable candidate for cemented primary total knee arthroplasty 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 DePuy.

* Subject is currently not bedridden.

* Subject in the opinion of the Clinical Investigator, is able to understand this clinical investigation and is willing and able to perform all study procedure and follow-up visits and co-operate with investigational procedures.

* Subject must be comfortable with speaking, reading and understanding questions and providing responses in an available translated language for the PROs in the protocol.

* The devices specified in this protocol were implanted.

Exclusion Criteria

* 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 (unilateral, bicompartmental or patellofemoral joint replacement), patellectomy, high tibial osteotomy or primary TKA in affected knee.

* Subject is currently experiencing radicular pain from the spine.

* Subject has participated in an IDE/IND clinical investigation with an investigational product in the last three months.

* Subject is currently involved in any personal injury litigation, medical-legal or worker's compensation claims.

* Subject is a known drug or alcohol abuser or has a psychological disorder that could affect their ability to complete patient reported questionnaires.

* Subject was diagnosed with fibromyalgia that is currently being treated with prescription medication.

* Subject has significant neurological or musculoskeletal disorders 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 erythematosis, etc.).

* Subject is not comfortable with speaking, reading, and understanding questions and providing responses in an available translated language for the PROs in the protocol.

* Subject has a medical condition with less than 5 years of life expectancy.