14022 ATTUNE Cementless RP Clinical Performance Evaluation

Conditions:Arthritis, Osteoarthritis (OA)
Therapuetic Areas:Rheumatology
Age Range:22 - 80
Start Date:September 1, 2016
End Date:June 1, 2024
Contact:Sue Kemp

Use our guide to learn which trials are right for you!

Multi-Center Clinical Evaluation of the ATTUNE Cementless Rotating Platform Total Knee Arthroplasty

The primary objective of this study is to examine the change from pre-operative baseline to
two year postoperative functional performance improvement for the ATTUNE primary, cementless
TKA RP system as measured with the KOOS questionnaire (KOOS-ADL sub-score). This will be
carried out for two configurations: cruciate retaining rotating platform (ATTUNE Cementless
CR RP) and posterior stabilized rotating platform (ATTUNE Cementless PS RP).

The secondary objectives of this study are:

- Evaluate change from preoperative baseline in post-operative outcomes using additional
patient reported measures at 2 years: PKIP (overall and sub-scores), KOOS (overall and
sub-scores), AKS and EQ-5D-3L.

- Evaluate change from preoperative baseline in pain and satisfaction over time as
measured using a modified VAS Pain Score (discrete numbers rather than a continual
scale) at 2yr.

- Evaluate type and frequency of Adverse Events

- Evaluate survivorship of the ATTUNE Primary Cementless TKA system for the CR RP and PS
RP configurations using Kaplan-Meier survival analysis at 2yr and 5yrs.

- Evaluate primary, cementless ATTUNE TKA fixation through zonal radiographic analysis of
the bone-implant interface at 6wk, 6mo, 1yr, and 2yr after surgery.

- Evaluate any changes in anatomic tibiofemoral, femoral component and tibial component
alignment at 2 years compared to the first postoperative radiographs.

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 NIDJD.

- Subject, in the opinion of the Investigator, is a suitable candidate for cementless
primary TKA using the devices described in this CIP with either resurfaced or
non-resurfaced patellae.

- 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

- 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 read, and comprehend the Informed Consent Document as well as
complete the required PROs in either English or one of the available 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

- Subject is currently diagnosed with 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 (3) 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

- 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 five (5) years life expectancy.

- Uncontrolled gout
We found this trial at
Newport News, VA
Click here to add this to my saved trials
DeLand, FL
Click here to add this to my saved trials
Lubbock, TX
Click here to add this to my saved trials
New London, NH
Click here to add this to my saved trials
Ried im Innkreis, Upper Austria
Principal Investigator: Norbert Freund
Phone: +437752602
Ried im Innkreis,
Click here to add this to my saved trials