Home Monitoring After Primary Total Knee Arthroplasty
2022年1月14日 更新者：Carlos Higuera-Rueda、The Cleveland Clinic
Feasibility of Home Monitoring After Primary Total Knee Arthroplasty
Home monitoring technologies have recently emerged in many different areas of healthcare.
These technologies are being used to provide rehabilitation to patients, and to prevent, identify, and manage complications.
The investigators are proposing a method to monitor and communicate with patients during the first 12 weeks after total knee arthroplasty (TKA) using an electronic home-based patient monitoring system with unique connectivity capabilities and prescriptive controls.
The investigators will prospectively, electronically capture range of motion and gait parameters at specified intervals using Bluetooth sensors worn by the patient.
The unique in-home patient monitoring platform will be utilized by 10 TKA patients once they return home following surgery.
The investigators hypothesize that the use of an internet based home patient monitoring technology platform will reliably provide information related to the patients' pain and function and enhance patient feedback and communication after TKA.
The hypothesis will be tested with the following aim: 1) To test the reliability of all technology utilized within the patient's home including but not limited to the sensors, the communication controller, the patient interface (Android tablet) and the internet by prospectively comparing between data collected through the home monitoring technology and traditional clinical measurements taken during physical therapy and surgical follow-up visits.
調査の概要
詳細な説明
Over one million primary total hip and total knee arthroplasty (TKA) surgeries are being performed annually in the U.S. and this number is expected to increase over the next seven years, along with a simultaneously projected shortage of trained orthopaedic surgeons to care for these patients.
This proposal addresses the optimization of the surgeons' clinical time through utilization of innovative home based technologies to monitor and communicate with patients during the first 12 weeks after total knee arthroplasty.
This will be accomplished by establishing home monitoring connectivity with novel technology and measure validated patient-reported outcomes, knee ROM and gait parameters in a postoperative TKA patient's native living environment.
It will allow the investigators to prospectively, electronically capture clinically relevant TKA outcomes at the patient's home and provide insight into postoperative rehabilitation progress, predictors of suboptimal clinical outcomes, and guide future randomized controlled trial development to improve outcomes.
研究の種類
介入
入学 (実際)
10
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
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Ohio
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Cleveland、Ohio、アメリカ、44195
- Cleveland Clinic Foundation
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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年歳以上 (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:
- Unilateral primary TKA
- Surgery is performed at Cleveland Clinic Main Campus or at Lutheran Hospital
- Patient must reside within 75 miles (driving distance) from Cleveland Clinic Main Campus
- Patient expected to utilize Cleveland Clinic Home Care Services after surgery
Exclusion Criteria:
- Revision or simultaneous bilateral TKA
- English is not the patient's preferred language for healthcare discussions
- Currently participating in any other research study
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：ヘルスサービス研究
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- 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 |
|---|---|
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実験的：At-Home Monitoring
Patients will follow-up in clinic postoperatively at 4, 8, and 12 weeks and their recovery will also be monitored using sensors and communication devices while they are at home after surgery.
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Patient reported outcomes, functional measures such as the maximum attainable range of motion (AROM) and the number of steps taken will be tracked using sensors worn by the patient.
The AROM sensor values will be verified with range of motion measurements taken using a goniometer during therapy and MD visits.
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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 |
|---|---|---|
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Overall Reliability of Monitoring Technology, Measured as Proportion of Actual Data Received From the Patient's Home Compared to the Amount of Data Expected (Based on Activities That Were Reported as Completed by Patients) Over the 12 Week Study Period.
時間枠：daily, from the date of discharge until the 12 week postoperative follow-up appointment has occurred
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The investigators will determine the reliability of the at-home monitoring technology for recording and transmitting data from the patient's home to the healthcare provider. This will be measured for each patient individually and then combined to form an aggregate measurement. Reliability of the technology to collect data was calculated for each patient individually by counting the number of times data (range of motion, TUG test results, VAS Pain score, etc) was received and dividing that number by the number of times data was expected (activities reported as complete by patients). This was then converted into a percentage. Additionally, this number was aggregated by combining the numerators (activities received) for all patients and denominators (activities complete) for all patients and determining the overall reliability of the technology. |
daily, from the date of discharge until the 12 week postoperative follow-up appointment has occurred
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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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Rehab Compliance
時間枠：Percentage of exercises completed 2-3 times daily, from the date of discharge up to approximately 4 weeks postoperatively when outpatient physical therapy begins
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Percentage of required at-home therapy exercises completed each session, as well as the total percentage completed during all home therapy sessions
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Percentage of exercises completed 2-3 times daily, from the date of discharge up to approximately 4 weeks postoperatively when outpatient physical therapy begins
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Change From Preoperative to Postoperative Knee Range of Motion
時間枠：Once preoperatively then postoperatively 2-3 times daily from the date of discharge until the 12 week postoperative follow-up appointment has occurred
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Change from Preoperative to Postoperative Knee Range of Motion, Knee range of motion is recorded daily using sensors above and below the knee.
Please note: only data from sensors is being reported
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Once preoperatively then postoperatively 2-3 times daily from the date of discharge until the 12 week postoperative follow-up appointment has occurred
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Change From Preoperative to Postoperative Timed Up and Go Test
時間枠：Once preoperatively then postoperatively 2-3 times daily from the date of discharge until the 12 week postoperative follow-up appointment has occurred
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Change from Preoperative to Postoperative Timed Up and Go Test.
The time that a patient takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down.
This time was recorded electronically by the patient at home using the tablet.
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Once preoperatively then postoperatively 2-3 times daily from the date of discharge until the 12 week postoperative follow-up appointment has occurred
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Visual Analog Scale for Pain (Knee-related Pain at Its Worst Over a 24 Hour Period)
時間枠：Once preoperatively then postoperatively 2-3 times daily from the date of discharge until the 12 week postoperative follow-up appointment has occurred
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Knee-related pain was measured using a visual analog scale with numeric values added to the line.
Zero (0) is the minimum value and 10 is the maximum value.
A score of 0 indicates no pain and a score of 10 indicates the worst pain imaginable.
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Once preoperatively then postoperatively 2-3 times daily from the date of discharge until the 12 week postoperative follow-up appointment has occurred
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Knee Injury and Osteoarthritis Outcome Score (KOOS) - KOOS Pain
時間枠：Once preoperatively then postoperatively once weekly from the date of discharge until the 12 week follow-up appointment has occurred
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We will assess KOOS Pain using 9 questions, each response given a point value from 0 to 4. The sum of these points will total between 0 and 36 points.
This score will be normalized to a 100 point scale where 100 means no pain and 0 is extreme pain.
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Once preoperatively then postoperatively once weekly from the date of discharge until the 12 week follow-up appointment has occurred
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Knee Injury and Osteoarthritis Outcome Score (KOOS) - KOOS PS (Physical Function Short Form)
時間枠：Once preoperatively then postoperatively once weekly from the date of discharge until the 12 week follow-up appointment has occurred
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We will assess KOOS Function using 7 questions, each response given a point value from 0 to 4. The sum of these points will total between 0 and 28 points.
This total will be normalized to a 100 point scale where 100 means no functional difficulty and 0 is extreme difficulty.
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Once preoperatively then postoperatively once weekly from the date of discharge until the 12 week follow-up appointment has occurred
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Knee Injury and Osteoarthritis Outcome Score (KOOS) - KOOS QOL
時間枠：Once preoperatively then postoperatively once weekly from the date of discharge until the 12 week follow-up appointment has occurred
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We will assess KOOS QOL using 4 questions, each response given a point value from 0 to 4. The sum of these points will total between 0 and 16 points, which will then be normalized to a 100 point scale.
One hundred (100) means the knee does not affect quality of life and 0 indicates that the knee is a constant problem affecting quality of life.
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Once preoperatively then postoperatively once weekly from the date of discharge until the 12 week follow-up appointment has occurred
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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：Carlos Higuera, MD、Staff Surgeon
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
2016年7月1日
一次修了 (実際)
2017年5月2日
研究の完了 (実際)
2017年5月2日
試験登録日
最初に提出
2016年7月28日
QC基準を満たした最初の提出物
2017年1月24日
最初の投稿 (見積もり)
2017年1月26日
学習記録の更新
投稿された最後の更新 (実際)
2022年1月18日
QC基準を満たした最後の更新が送信されました
2022年1月14日
最終確認日
2022年1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。
At-Home Monitoringの臨床試験
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Nordsjaellands HospitalUniversity of Southern Denmark; Innovation Fund Denmark完了
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Karolinska Institutet完了
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KDH Research & Communication完了
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AZ Sint-Jan AV完了
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Philips Clinical & Medical Affairs Global募集