10003 PRO Current Products (10003)
Multi-center, Non-comparative Study of Primary Total Knee Arthroplasty (TKA) Functional Performance
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.
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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California
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Orange、California、アメリカ、92868
- Orthopaedic Specialty Institute
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San Diego、California、アメリカ、92103
- UCSD Medical Center
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Colorado
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Fort Collins、Colorado、アメリカ、80525
- Orthopaedic Center of the Rockies
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Florida
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Jacksonville、Florida、アメリカ、32205
- Heekin Institute for Orthopedic Research
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Kentucky
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Louisville、Kentucky、アメリカ、40215
- The Arthroplasty Foundation
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Louisiana
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New Orleans、Louisiana、アメリカ、70112
- Tulane University Hospital and Clinic
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Nevada
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Las Vegas、Nevada、アメリカ、89128
- Hip and Knee Research of Nevada
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New Hampshire
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Lebanon、New Hampshire、アメリカ、03756
- Dartmouth Medical School/Dartmouth-Hitchcock Medical Center
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Ohio
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Columbus、Ohio、アメリカ、43213
- Cardinal Orthopaedic Institute
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Virginia
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Alexandria、Virginia、アメリカ、22307-9804
- Anderson Orthopaedic Research Institute
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Washington
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Seattle、Washington、アメリカ、98122-5330
- Swedish Orthopedic Institute
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Harlow、イギリス、CM20 1QX
- Princess Alexandra Hospital
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Llandough、イギリス、CF64 2XX
- University Hospital Llandough
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Middlesborough、イギリス、TS4 3BW
- James Cook University Hospital
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York、イギリス、YO30 5RA
- Clifton Park NHS Treatment Centre
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Fife
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Dunfermline、Fife、イギリス、KY12 OSU
- Queen Margaret Hospital
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Surrey
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Guildford、Surrey、イギリス、GU2 7XX
- The Royal Surrey County Hospital
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New South Wales
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Hornsby、New South Wales、オーストラリア、2077
- Hornsby Ku-Ring-Gai Hospital
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South Australia
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Adelaide、South Australia、オーストラリア、5000
- Wakefield Orthopedic Clinic
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Western Australia
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Crawley、Western Australia、オーストラリア、6009
- Freemantle Hospital
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Perth、Western Australia、オーストラリア、6000
- Royal Perth Hospital
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Auckland、ニュージーランド
- Ascot Hospital
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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CR FB
Subjects receiving a Cruciate Retaining Fixed Bearing implant configuration
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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. |
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PS FB
Subjects Receiving a Posterior Stabilized Fixed Bearing implant configuration
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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. |
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CR RP
Subjects receiving a Cruciate Retaining Rotating Platform implant configuration
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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. |
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PS RP
Subjects receiving a Posterior Stabilized Rotating Platform implant configuration
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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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Knee injury and Osteoarthritis Outcome Score (KOOS) activities of daily living (ADL) sub-score
時間枠：up to one year
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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.
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up to one year
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Evaluate the psychometric properties of PKIP
時間枠：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)
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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.
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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)
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Evaluate the longitudinal functional performance of primary TKA
時間枠：< 1 year (1 to 303 days), minimum 1 year (304 to 668 days), minimum 2 year (669 to 1763 days)
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< 1 year (1 to 303 days), minimum 1 year (304 to 668 days), minimum 2 year (669 to 1763 days)
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Evaluate Incidence of Anterior Knee Pain
時間枠：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)
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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)
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Evaluate incidence of asymptomatic and symptomatic crepitus
時間枠：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)
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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)
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Evaluate patients functional performance for PS knees, CR knees, FB knees, and RP knees
時間枠：< 1 year (1 to 303 days), minimum 1 year (304 to 668 days), minimum 2 year (669 to 1763 days)
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< 1 year (1 to 303 days), minimum 1 year (304 to 668 days), minimum 2 year (669 to 1763 days)
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協力者と研究者
スポンサー
捜査官
- スタディディレクター：Ahmad S. Ismail, MS, CCRP、DePuy Orthopaedics
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。