10003 PRO Current Products
- Conditions
- Osteoarthritis
- Interventions
- Device: Total Knee Replacement
- Registration Number
- NCT01497730
- Lead Sponsor
- DePuy Orthopaedics
- Brief Summary
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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 842
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description CR RP Total Knee Replacement Subjects receiving a Cruciate Retaining Rotating Platform implant configuration PS RP Total Knee Replacement Subjects receiving a Posterior Stabilized Rotating Platform implant configuration PS FB Total Knee Replacement Subjects Receiving a Posterior Stabilized Fixed Bearing implant configuration CR FB Total Knee Replacement Subjects receiving a Cruciate Retaining Fixed Bearing implant configuration
- Primary Outcome Measures
Name Time Method Knee injury and Osteoarthritis Outcome Score (KOOS) activities of daily living (ADL) sub-score up to one year The primary endpoint will be measuerd before surgery and out to a minimum of 1 year after surgery. The KOOS is a patient self-administered questionnaire that consists of 42 questions. 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.
- Secondary Outcome Measures
Name Time Method Evaluate the psychometric properties of PKIP Pre-op (-90 to -1 days before surgery), < 1 year (1 to 303 days), minimum 1 year (304 to 668 days), minimum 2 year (669 to 1763 days) The Pre and 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.
Evaluate the longitudinal functional performance of primary TKA < 1 year (1 to 303 days), minimum 1 year (304 to 668 days), minimum 2 year (669 to 1763 days) Evaluate Incidence of Anterior Knee Pain Pre-op (-90 to -1 days before surgery), < 1 year (1 to 303 days), minimum 1 year (304 to 668 days), minimum 2 year (669 to 1763 days) Evaluate incidence of asymptomatic and symptomatic crepitus Pre-op (-90 to -1 days before surgery), < 1 year (1 to 303 days), minimum 1 year (304 to 668 days), minimum 2 year (669 to 1763 days) Evaluate patients functional performance for PS knees, CR knees, FB knees, and RP knees < 1 year (1 to 303 days), minimum 1 year (304 to 668 days), minimum 2 year (669 to 1763 days)
Trial Locations
- Locations (22)
Queen Margaret Hospital
🇬🇧Dunfermline, Fife, United Kingdom
The Royal Surrey County Hospital
🇬🇧Guildford, Surrey, United Kingdom
Orthopaedic Center of the Rockies
🇺🇸Fort Collins, Colorado, United States
Heekin Institute for Orthopedic Research
🇺🇸Jacksonville, Florida, United States
Orthopaedic Specialty Institute
🇺🇸Orange, California, United States
The Arthroplasty Foundation
🇺🇸Louisville, Kentucky, United States
Tulane University Hospital and Clinic
🇺🇸New Orleans, Louisiana, United States
Anderson Orthopaedic Research Institute
🇺🇸Alexandria, Virginia, United States
Dartmouth Medical School/Dartmouth-Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
Hornsby Ku-ring-gai Hospital
🇦🇺Hornsby, New South Wales, Australia
Freemantle Hospital
🇦🇺Crawley, Western Australia, Australia
Ascot Hospital
🇳🇿Auckland, New Zealand
Princess Alexandra Hospital
🇬🇧Harlow, United Kingdom
James Cook University Hospital
🇬🇧Middlesborough, United Kingdom
Clifton Park NHS Treatment Centre
🇬🇧York, United Kingdom
Royal Perth Hospital
🇦🇺Perth, Western Australia, Australia
UCSD Medical Center
🇺🇸San Diego, California, United States
Hip and Knee Research of Nevada
🇺🇸Las Vegas, Nevada, United States
Cardinal Orthopaedic Institute
🇺🇸Columbus, Ohio, United States
Swedish Orthopedic Institute
🇺🇸Seattle, Washington, United States
Wakefield Orthopedic Clinic
🇦🇺Adelaide, South Australia, Australia
University Hospital Llandough
🇬🇧Llandough, United Kingdom