14022 ATTUNE Cementless RP Clinical Performance Evaluation

N/AActive Not RecruitingNCT02839850

DePuy Orthopaedics540 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

540

Conditions

Osteoarthritis

Interventions

Cementless Total Knee ArthroplastyDEVICE

Patients will undergo a primary total knee replacement using one of the two configurations of the ATTUNE Cementless knee (CR RP or PS RP)

Eligibility

Sex: ALLMin age: 22 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (20)

Colorado Joint Replacement

Denver, Colorado, United States

Outcomes

Primary Outcomes

Patient-reported Outcome: Knee Injury and Osteoarthritis Outcome Score Activities of Daily Living (KOOS ADL)

The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient self-administered questionnaire that consists of 42 questions and include the WOMAC Osteoarthritis index. The KOOS consists of 5 subscales: pain, other symptoms, activities of daily living (ADL), sport and recreational function and knee related quality of life. Each question has 5 Likert-like response options. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.

Time frame: Minimum 2 years (670-1033 days after surgery)

Secondary Outcomes

Patient-reported Outcome: Pre-surgical/Post-surgical Patient's Knee Implant Performance (PKIP)

The Pre Surgical and/or Post-surgical Patient's Knee Implant Performance (PKIP) questionnaire is a patient self-administered questionnaire that consists of 25 questions relating to the patient's awareness of their knee. Questions include the patient's self-confidence about the current status of their knee performance, stability, and overall satisfaction. Each question has a 5, 6 or 10 Likert- like response option.

Time frame: Minimum 2 years (670-1033 days after surgery)

Patient-reported Outcome: Knee Injury and Osteoarthritis Outcome Score (KOOS)

Time frame: Minimum 2 years (670-1033 days after surgery)

Combination of Patient-reported and Clinical-reported Outcome: Knee Society 2011

The Knee Society Score is a self-administered questionnaire. The subject completes questions regarding: Symptoms (3 questions), Patient Satisfaction (5 questions), Patient Expectations (3 questions), Functional Activities (5 questions), Standard Activities (6 questions), Advanced Activities (5 questions), and Discretionary Knee Activities ( 4 questions). The surgeon completes questions regarding objective knee indicators. Likert responses are used, typically with five response options.

Data from ClinicalTrials.gov

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