Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
842 participants
OBSERVATIONAL
2011-10-01
2018-08-10
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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CR FB
Subjects receiving a Cruciate Retaining Fixed Bearing implant configuration
Total Knee Replacement
Subjects will receive one of the following total knee implants:
PFC Sigma Fixed Bearing (FB) cruciate retaining (CR), posterior stabilized (PS) or Rotating Platform CR or PS devices. LCS Rotating platform or PS devices. Triathlon CR, PS or mobile bearing devices. NexGen CR, LPS, LPS Flex FB PS, LPS Flex Mobile bearing, or LPS Mobile bearing devices.
PS FB
Subjects Receiving a Posterior Stabilized Fixed Bearing implant configuration
Total Knee Replacement
Subjects will receive one of the following total knee implants:
PFC Sigma Fixed Bearing (FB) cruciate retaining (CR), posterior stabilized (PS) or Rotating Platform CR or PS devices. LCS Rotating platform or PS devices. Triathlon CR, PS or mobile bearing devices. NexGen CR, LPS, LPS Flex FB PS, LPS Flex Mobile bearing, or LPS Mobile bearing devices.
CR RP
Subjects receiving a Cruciate Retaining Rotating Platform implant configuration
Total Knee Replacement
Subjects will receive one of the following total knee implants:
PFC Sigma Fixed Bearing (FB) cruciate retaining (CR), posterior stabilized (PS) or Rotating Platform CR or PS devices. LCS Rotating platform or PS devices. Triathlon CR, PS or mobile bearing devices. NexGen CR, LPS, LPS Flex FB PS, LPS Flex Mobile bearing, or LPS Mobile bearing devices.
PS RP
Subjects receiving a Posterior Stabilized Rotating Platform implant configuration
Total Knee Replacement
Subjects will receive one of the following total knee implants:
PFC Sigma Fixed Bearing (FB) cruciate retaining (CR), posterior stabilized (PS) or Rotating Platform CR or PS devices. LCS Rotating platform or PS devices. Triathlon CR, PS or mobile bearing devices. NexGen CR, LPS, LPS Flex FB PS, LPS Flex Mobile bearing, or LPS Mobile bearing devices.
Interventions
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Total Knee Replacement
Subjects will receive one of the following total knee implants:
PFC Sigma Fixed Bearing (FB) cruciate retaining (CR), posterior stabilized (PS) or Rotating Platform CR or PS devices. LCS Rotating platform or PS devices. Triathlon CR, PS or mobile bearing devices. NexGen CR, LPS, LPS Flex FB PS, LPS Flex Mobile bearing, or LPS Mobile bearing devices.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
22 Years
80 Years
ALL
No
Sponsors
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DePuy Orthopaedics
INDUSTRY
Responsible Party
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Principal Investigators
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Ahmad S. Ismail, MS, CCRP
Role: STUDY_DIRECTOR
DePuy Orthopaedics
Locations
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Orthopaedic Specialty Institute
Orange, California, United States
UCSD Medical Center
San Diego, California, United States
Orthopaedic Center of the Rockies
Fort Collins, Colorado, United States
Heekin Institute for Orthopedic Research
Jacksonville, Florida, United States
The Arthroplasty Foundation
Louisville, Kentucky, United States
Tulane University Hospital and Clinic
New Orleans, Louisiana, United States
Hip and Knee Research of Nevada
Las Vegas, Nevada, United States
Dartmouth Medical School/Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Cardinal Orthopaedic Institute
Columbus, Ohio, United States
Anderson Orthopaedic Research Institute
Alexandria, Virginia, United States
Swedish Orthopedic Institute
Seattle, Washington, United States
Hornsby Ku-ring-gai Hospital
Hornsby, New South Wales, Australia
Wakefield Orthopedic Clinic
Adelaide, South Australia, Australia
Freemantle Hospital
Crawley, Western Australia, Australia
Royal Perth Hospital
Perth, Western Australia, Australia
Ascot Hospital
Auckland, , New Zealand
Queen Margaret Hospital
Dunfermline, Fife, United Kingdom
The Royal Surrey County Hospital
Guildford, Surrey, United Kingdom
Princess Alexandra Hospital
Harlow, , United Kingdom
University Hospital Llandough
Llandough, , United Kingdom
James Cook University Hospital
Middlesbrough, , United Kingdom
Clifton Park NHS Treatment Centre
York, , United Kingdom
Countries
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References
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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.
Other Identifiers
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10003
Identifier Type: -
Identifier Source: org_study_id
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