Multi-center, Non-comparative Study of Primary Total Knee Arthroplasty (TKA) Functional Performance
| Status: | Completed |
|---|---|
| Conditions: | Arthritis, Osteoarthritis (OA), Orthopedic |
| Therapuetic Areas: | Rheumatology, Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 22 - 80 |
| Updated: | 4/3/2019 |
| Start Date: | October 1, 2011 |
| End Date: | August 10, 2018 |
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.
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.
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.
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.
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.
We found this trial at
12
sites
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