Clinical trial NCT01497730: 10003 PRO Current Products
Official title: Multi-center, Non-comparative Study of Primary Total Knee Arthroplasty (TKA) Functional Performance
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis
Keywords: Arthroplasty, Replacement, Knee,
Lead sponsor: DePuy Orthopaedics
Sponsor class: INDUSTRY
First posted: 2011-12-22
Enrollment: 842
Sex: ALL
Minimum age (years): 22
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male and female Subjects with Non-inflammatory Degenerative Joint Disease (NIDJD) who require primary TKA with one of several designated knee systems currently on the market and are aged 22 to 80 years, inclusive.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Knee injury and Osteoarthritis Outcome Score (KOOS) activities of daily living (ADL) sub-score
timeFrame: up to one year
Secondary outcomes:
measure: Evaluate the psychometric properties of PKIP
timeFrame: 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)
measure: Evaluate the longitudinal functional performance of primary TKA
timeFrame: < 1 year (1 to 303 days), minimum 1 year (304 to 668 days), minimum 2 year (669 to 1763 days)
measure: Evaluate Incidence of Anterior Knee Pain
timeFrame: 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)
measure: Evaluate incidence of asymptomatic and symptomatic crepitus
timeFrame: 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)
measure: Evaluate patients functional performance for PS knees, CR knees, FB knees, and RP knees
timeFrame: < 1 year (1 to 303 days), minimum 1 year (304 to 668 days), minimum 2 year (669 to 1763 days)
Other outcomes:
Locations:
city: Orange
country: United States
facility: Orthopaedic Specialty Institute
state: California
city: San Diego
country: United States
facility: UCSD Medical Center
state: California
city: Fort Collins
country: United States
facility: Orthopaedic Center of the Rockies
state: Colorado
city: Jacksonville
country: United States
facility: Heekin Institute for Orthopedic Research
state: Florida
city: Louisville
country: United States
facility: The Arthroplasty Foundation
state: Kentucky
city: New Orleans
country: United States
facility: Tulane University Hospital and Clinic
state: Louisiana
city: Las Vegas
country: United States
facility: Hip and Knee Research of Nevada
state: Nevada
city: Lebanon
country: United States
facility: Dartmouth Medical School/Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: Columbus
country: United States
facility: Cardinal Orthopaedic Institute
state: Ohio
city: Alexandria
country: United States
facility: Anderson Orthopaedic Research Institute
state: Virginia
city: Seattle
country: United States
facility: Swedish Orthopedic Institute
state: Washington
city: Hornsby
country: Australia
facility: Hornsby Ku-ring-gai Hospital
state: New South Wales
city: Adelaide
country: Australia
facility: Wakefield Orthopedic Clinic
state: South Australia
city: Crawley
country: Australia
facility: Freemantle Hospital
state: Western Australia
city: Perth
country: Australia
facility: Royal Perth Hospital
state: Western Australia
city: Auckland
country: New Zealand
facility: Ascot Hospital
city: Dunfermline
country: United Kingdom
facility: Queen Margaret Hospital
state: Fife
city: Guildford
country: United Kingdom
facility: The Royal Surrey County Hospital
state: Surrey
city: Harlow
country: United Kingdom
facility: Princess Alexandra Hospital
city: Llandough
country: United Kingdom
facility: University Hospital Llandough
city: Middlesborough
country: United Kingdom
facility: James Cook University Hospital
city: York
country: United Kingdom
facility: Clifton Park NHS Treatment Centre
Study officials:
affiliation: DePuy Orthopaedics
name: Ahmad S. Ismail, MS, CCRP
role: STUDY_DIRECTOR
References:
citation: Hamilton WG, Brenkel IJ, Barnett SL, Allen PW, Dwyer KA, Lesko JP, Kantor SR, Clatworthy MG. Comparison of Existing and New Total Knee Arthroplasty Implant Systems From the Same Manufacturer: A Prospective, Multicenter Study. J Am Acad Orthop Surg Glob Res Rev. 2021 Dec 15;5(12):e21.00136. doi: 10.5435/JAAOSGlobal-D-21-00136.