Total Knee Arthroplasty: Functional and Clinical Outcomes
2017年4月28日 更新者：Duke University
Clinical and Functional Outcomes Following Total Knee Replacement Using Two Different Implants
The purpose of this study is to assess the differences in functional and patient reported outcomes between total knee replacement (TKA) implants.
In addition, this work will examine the correlation between functional assessments and patient reported outcomes following surgery.
All subjects will complete assessments preoperatively, 4-6 weeks following TKA and then one year following TKA.
Subjects will complete a series of patient reported outcomes as well as a series of functional outcomes at each of the time points of interest.
The analysis will include a repeated measures design to determine differences between groups across time as well as correlations between the functional and patient reported outcomes.
This work will hopefully determine the importance of using objective functional outcomes following TKA as well as determining the need for patient assessments out to one year following surgery.
調査の概要
詳細な説明
The number differences in subjects analyzed from baseline to 6 weeks to 52 weeks are due to the fact that we did not use the 6 week time point in the final analysis based on the clinical decision that 6 weeks was too early in recovery to provide accurate information for clinical decision making.
Therefore the patients used in the final analysis were those subjects who were able to and completed the assessment at pre-op and 1 year post-op which is how we get to the 20 subjects per group.
研究の種類
介入
入学 (実際)
60
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
North Carolina
-
Durham、North Carolina、アメリカ、27710
- Duke University Medical Center
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～85年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- Patients requiring primary total knee replacement
- Patients willing and able to comply with the follow-up visits and evaluations
- Patients willing to sign informed consent approved by the Institutional Review Board
Exclusion Criteria:
- Patients with inflammatory arthritis
- Patients with diabetic neuropathy
- Patients unable to ambulate without the use of an assistive device prior to surgery
- Patients unable to stand in single limb stance on each foot prior to surgery.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：Stryker
Subjects will be receiving the Stryker Triathlon total knee replacement
|
|
|
アクティブコンパレータ：Zimmer
Subjects will be receiving a Zimmer NexGen total knee replacement
|
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 |
|---|---|---|
|
Change in Lower Quarter Y-Balance Test (YBT-LQ) (Dynamic Balance) From Baseline to 6 Weeks Following Total Knee Replacement
時間枠：Baseline (Pre-Operative) to 6 weeks following total knee replacement
|
The lower quarter y-balance test (YBT-LQ) is a test of dynamic balance in unilateral stance that has been deemed to be reliable and valid.
The YBT-LQ consists of each patient standing on one leg and reaching as far as they can with their non-stance leg in the anterior, posteromedial and posterolateral direction while standing on the other foot on a centralized stance platform.
The composite score is calculated as the sum of the three reach directions divided by 3 time the limb length and will be reported as a percentage of limb length.
|
Baseline (Pre-Operative) to 6 weeks following total knee replacement
|
|
Change in Lower Quarter Y-Balance Test (YBT-LQ) (Dynamic Balance) From Baseline to 52 Weeks Following Total Knee Replacement
時間枠：Baseline (Pre-Operative) to 52 weeks following total knee replacement
|
The lower quarter y-balance test (YBT-LQ) is a test of dynamic balance in unilateral stance that has been deemed to be reliable and valid.
The YBT-LQ consists of each patient standing on one leg and reaching as far as they can with their non-stance leg in the anterior, posteromedial and posterolateral direction while standing on the other foot on a centralized stance platform.
The composite score is calculated as the sum of the three reach directions divided by 3 time the limb length and will be reported as a percentage of limb length.
|
Baseline (Pre-Operative) to 52 weeks following total knee replacement
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Walking Speed From Baseline to 52 Weeks Following Total Knee Replacement.
時間枠：Baseline and 52 weeks following total knee replacement
|
Each subject will complete three walking trials at a self-selected comfortable walking speed along a 5 meter walkway in order to record walking speed at each time point.
|
Baseline and 52 weeks following total knee replacement
|
|
Walking Speed at 6 Weeks Following Total Knee Replacement.
時間枠：6 weeks following total knee replacement
|
Each subject will complete three walking trials at a self-selected comfortable walking speed along a 5 meter walkway in order to record walking speed at each time point.
|
6 weeks following total knee replacement
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in University of California, Los Angeles (UCLA) Activity Score From Baseline to 52 Weeks Following Total Knee Replacement.
時間枠：Baseline and 52 weeks following total knee replacement
|
The UCLA activity score is a validated patient reported outcome of overall physical activity.
Results on a scale of 1 to 10, 1 is "Wholly Inactive, dependent on others, and can not leave residence" and 10 is "Regularly participates in impact sports".
|
Baseline and 52 weeks following total knee replacement
|
|
University of California, Los Angeles (UCLA) Activity Score at 6 Weeks Following Total Knee Replacement.
時間枠：6 weeks following total knee replacement
|
The UCLA activity score is a validated patient reported outcome of overall physical activity.
Results on a scale of 1 to 10, 1 is "Wholly Inactive, dependent on others, and can not leave residence" and 10 is "Regularly participates in impact sports".
|
6 weeks following total knee replacement
|
|
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) Total From Baseline to 52 Weeks Following Total Knee Replacement.
時間枠：Baseline (Pre-Operative) and 52 weeks following total knee replacement
|
The KOOS is a standardized and validated patient outcome score that assesses functional limitation in patient with knee problems.
KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL).
The previous week is the time period considered when answering the questions.
Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.
|
Baseline (Pre-Operative) and 52 weeks following total knee replacement
|
|
Change in Forgotten Joint Score (FJS) From 6 Weeks to 52 Weeks Following Total Knee Replacement.
時間枠：6 weeks and 52 weeks following total knee replacement
|
The FJS is a patient reported measure of how bothersome the total joint replacement is for them, how much it affects daily activity and how much they are aware of the implant.
The FJS is a 12-question survey regarding functional outcome, pain, stability, daily living, activity and sport.
Scoring is from 0 to 4 with 0 as the best outcome; a low score means high satisfaction.
Not all questions must be answered to score, all responses are summed and the total is divided by number of completed items multiplied by 25, with the final result subtracted from 100.
The score range is from 0 to 100 with the highest score of 100 indicating the best outcome (the joint is completely "forgotten") and 0 indicating the worst outcome.
|
6 weeks and 52 weeks following total knee replacement
|
|
Knee Society Score (KSS)
時間枠：Baseline (Pre-Operative), 6 weeks and 52 weeks following total knee replacement
|
The KSS is a patient reported measure of knee function that is specific to patients who are scheduled to receive or have previously had a total knee replacement.
This outcome measures both patient reported pain and function changes from prior to surgery through recovery.
The score range is from 0 to 100.
The highest score of 100 points will be obtained by a well-aligned knee with no pain, 125 degrees of motion, and negligible anteroposterior and mediolateral instability.
|
Baseline (Pre-Operative), 6 weeks and 52 weeks following total knee replacement
|
|
Sit to Stand Time
時間枠：Baseline (Pre-Operative), 6 weeks and 52 weeks following total knee replacement
|
The sit to stand test requires patients to stand up and sit down as many times as possible in 10 seconds from a standard arm chair.
|
Baseline (Pre-Operative), 6 weeks and 52 weeks following total knee replacement
|
|
Timed Get up and go
時間枠：Baseline (Pre-Operative), 6 weeks and 52 weeks following total knee replacement
|
The timed up and go requires a patient to rise from a chair walk three meters around a piece of tape and return to the chair again as quickly as possible.
|
Baseline (Pre-Operative), 6 weeks and 52 weeks following total knee replacement
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Samuel S Wellman, MD、Duke University
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2013年2月1日
一次修了 (実際)
2016年2月26日
研究の完了 (実際)
2016年2月26日
試験登録日
最初に提出
2013年3月12日
QC基準を満たした最初の提出物
2013年3月12日
最初の投稿 (見積もり)
2013年3月14日
学習記録の更新
投稿された最後の更新 (実際)
2017年6月2日
QC基準を満たした最後の更新が送信されました
2017年4月28日
最終確認日
2017年4月1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。