10003 PRO Current Products

DePuy Synthes

Status

Completed

Conditions

Osteoarthritis

Treatments

Device: Total Knee Replacement

Study type

Observational

Funder types

Industry

Identifiers

NCT01497730

10003

Details and patient eligibility

About

This post-marketing investigation will evaluate the functional knee performance of Subjects who have undergone primary total knee arthroplasty (TKA). Data from Subjects who receive one of four contemporary knee configurations from different manufacturers will be pooled to establish a contemporary dataset.

The primary objective of this study is to evaluate the functional performance as measured by the activities of daily living (ADL) sub-score of the Knee Osteoarthritis Outcomes Score (KOOS) patient-reported outcome (PRO) questionnaire of primary TKA at minimum one year post-operation. This will be carried out for all four implant configurations. The final endpoint is a 2-year evaluation.

Full description

The study is designed as a prospective, single arm stratified, multi-center investigation.

Approximately 20 study sites, worldwide, will enroll 840 patients (840 knees). Each study site is expected to enroll approximately 42 patients (42 knees). Cohort reallocation is permitted. There will be no control group. Eight hundred forty (840) Subjects will be stratified into 4 subgroups of 210: fixed bearing cruciate retaining (FB CR), fixed bearing posterior stabilized (FB PS), rotating platform cruciate retaining (RP CR), and rotating platform posterior stabilized (RP PS).

Treatment assignment in this study is not randomized. Each site will only enroll patients in one of the four knee configuration sub-groups most commonly used as their standard of care.

Enrollment

842 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, inclusive.
Subject was diagnosed with NIDJD.
Subject is a suitable candidate for cemented primary TKA using the devices described in this CIP with either a resurfaced or non-resurfaced patellae.
Subject's TKA device was one of the total knee prostheses described under Interventions.
Subject is currently not bedridden.
Subject has given voluntary, written informed consent to participate in this clinical investigation, is willing and able to perform all study procedures and follow-up visits and has authorized the transfer of his/her information to DePuy.
Subject, in the opinion of the Clinical Investigator, is able to understand this clinical investigation and co-operate with investigational procedures.
Subject must be comfortable with speaking, reading, and understanding questions and providing responses in English.
The devices specified in this CIP were implanted.

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 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 erythematosus, etc.).
Subject is not comfortable with speaking, reading, and understanding questions and providing responses in an available translated language for the PROs in the CIP.
Subject has a medical condition with less than 2 years of life expectancy.