Journey II BCS CMS Total Knee System Compared to Other PS Total Knee Systems in PT Setting
A Non-Randomized, Prospective Study of Short Term Outcomes Following Total Knee Replacement With JOURNEY™ II BCS Total Knee System Compared to Other Posterior Stabilized Total Knee Systems in a Physical Therapy Setting
The primary objective of the study is to determine how the short-term outcome of subjects implanted with the JOURNEY™ II BCS Total Knee System compares to subjects implanted with other PS total knee systems, and to determine if there is a difference in health care resources consumed that may result in economic savings to patients, the facility and/or the payer.
To address the study objectives, patient self-assessment questionnaires, and other objective measures of post-operative function and health care resource utilization will be used for data collection.
調査の概要
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Maryland
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Annapolis、Maryland、アメリカ、21401
- Anne Arundel Medical Cneter
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Oregon
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Eugene、Oregon、アメリカ、97401
- Slocum Research & Educational Foundation
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Pennsylvania
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State College、Pennsylvania、アメリカ、16801
- University Orthopaedic Center
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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:
- Undergone unilateral primary total knee replacement with a JOURNEY™ II BCS Total Knee System or other Non-Smith & Nephew Posterior Stabilized Knee System
- Will be initiating outpatient PT ≤ 7 days post-operatively
- Has a primary diagnosis of osteoarthritis, degenerative arthritis, or traumatic arthritis
- Has pre-operative ROM ≥ 90°
- Is skeletally mature in the PI judgment
- Is 21 years of age of older
- Is willing and able to participate in required follow-up visits at the study site and to complete study procedures and questionnaires
- Has consented to participate in the study by signing the IRB/EC approved informed consent for the study
- Agrees to follow post- operative physical therapy program
Exclusion Criteria:
- Significant preoperative varus or valgus deformities (>15º)
- Has received a constrained or deep dish tibial insert
- Morbid obesity (BMI > 40)
- Has not obtained required pre-rehabilitation, pre-operative and intra-operative records by week 2 visit
- Other comorbidities that may impact outcomes such as osteoporosis, uncontrolled diabetes and active infection
- Fibromyalgia requiring treatment
- Current or impending incarceration or is a prisoner
- In the opinion of the PI has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study including mental illness, mental retardation, drug or alcohol abuse
- Is known to be at risk for lost to follow-up, or failure to return for scheduled visits
- Undergone or is planning to undergo total knee replacement of the contralateral knee within 6 months of this total knee replacement
- Requires a Legally Authorized Representative to consent to the study
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 |
|---|
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Journey II BCS Knee
Physical Therapy Observational
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All Other Posterior Stabilized Knees
Physical Therapy Observational
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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 |
|---|---|---|
|
Difference in Knee Range of Motion (ROM) at the first outpatient Physical Therapy (PT) visit (≤7 days of surgery) between the 2 treatment groups
時間枠:≤7 days of surgery
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The absolute Range of Motion of index knee will be compared between groups
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≤7 days of surgery
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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:Beate Hanson, MD、Smith & Nephew, Inc.
研究記録日
主要日程の研究
研究開始
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
本研究に関する用語
その他の研究ID番号
- Journey II BCS CMS Study
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
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。