14022 ATTUNE Cementless RP Clinical Performance Evaluation

DePuy Synthes

Status

Active, not recruiting

Conditions

Osteoarthritis

Treatments

Device: Cementless Total Knee Arthroplasty

Study type

Interventional

Funder types

Industry

Identifiers

NCT02839850

14022

Details and patient eligibility

About

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).

Full description

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.

Enrollment

540 estimated patients

Sex

All

Ages

22 to 80 years old

Volunteers

No 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 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 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 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 knee.
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 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 five (5) years life expectancy.
Uncontrolled gout