Preliminary Review of Cold and Active Compression Therapy for Traumatic Calcaneus or Ankle Fractures
Preliminary Efficacy and Cost-effectiveness Analysis of a Cold and Active Intermittent Compression Therapy Technique for Traumatic Calcaneus or Ankle Fractures
調査の概要
詳細な説明
Initial research has shown that cryocompression therapy applied post-operatively has been effective in reducing recovery time and improving health and pain factors related to patient recovery. However, there has been limited research into how this translates into positive economic outcomes for both the hospital and the patient. In addition, it can be reasonably hypothesized that the use of the cryocompression therapy system before surgery will lead to an increased rate of reduction in swelling necessary to allow proper operative procedures to take place when compared to the standard ice and elevation (RICE) therapy techniques and cryocompression therapy applied only post-operatively. This should lead to decreased hospital costs and possible improved patient outcomes related to recovery.
Study Objectives This study will examine the initial efficacy and cost-effectiveness of using the cryocompression therapy model both pre-operatively and post-operatively in patients that have recently suffered a traumatic calcaneus or ankle fracture compared to the standard pre-operative RICE therapy procedures.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Florida
-
Orlando、Florida、アメリカ、32804
- Florida Hospital
-
-
参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Patients over 18 years of age
- Able to provide informed consent
- Recent calcaneus or ankle fracture requiring fixation
- Injury is determined (by physician) to be an isolated, closed, low-energy bimalleolar fracture
Exclusion Criteria:
- Unable to provide informed consent
- History of Dementia or mental instability
- No recent additional fractures (within one year) at or around injury site
- Persons with symptoms of any kind of psychosocial disorder
- Any condition that the clinician feels would contraindicate for the postoperative test or control treatments
- Any conditions that would contraindicate using the Game Ready
- If the patient is prevented from transfer to the OR due to reasons other than medically necessary
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
- 主な目的：処理
- 割り当て：ランダム化
- 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 |
|---|---|
|
アクティブコンパレータ：RICE (control)
Standard of Care procedures including ice and elevation.
|
SOC ice and elevation
|
|
実験的：Cryocompression (experimental)
treatment using the GameReady cryotherapy system
|
Cryotherapy and compression
|
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 |
|---|---|---|
|
Time until surgery/Time until discharge (LOS)
時間枠：Measured from intake to time of surgery (days) and upon discharge from hospital (days). Estimated period of time to be up to 10 days until surgery and up to 7 days after surgery until discharge.
|
Reduction in length of stay (LOS) and time of effect (pre-/post-op)
|
Measured from intake to time of surgery (days) and upon discharge from hospital (days). Estimated period of time to be up to 10 days until surgery and up to 7 days after surgery until discharge.
|
|
Change in Swelling as measured by point of largest swollen area (tape measure)
時間枠：Measured at baseline and all follow-up assessments (2, 8, 16, & 24-weeks post-op)
|
Measured at circumference of swelling point
|
Measured at baseline and all follow-up assessments (2, 8, 16, & 24-weeks post-op)
|
|
Total Narcotic Use as recorded on MR chart and Knee Pain Assessment
時間枠：Measured daily while inpatient (approx 2-3 days) and retroactively at all follow-up assessments (2, 8, 16, & 24-weeks post-op)
|
reported as yes/no and amount/type on assessment form
|
Measured daily while inpatient (approx 2-3 days) and retroactively at all follow-up assessments (2, 8, 16, & 24-weeks post-op)
|
|
Change in Patient reported pain as measured on VAS and Knee Pain Assessment
時間枠：Reported at baseline, daily while inpatient (approx 2-3 days), and at all follow-up assessments (2, 8, 16, & 24-weeks post-op)
|
As reported by VAS scale
|
Reported at baseline, daily while inpatient (approx 2-3 days), and at all follow-up assessments (2, 8, 16, & 24-weeks post-op)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Quality of Life (QALY) as measured on QOL and SF-8
時間枠：At baseline and all follow-up assessments (2, 8, 16, & 24-weeks post-op)
|
Quality of Life by QALY score
|
At baseline and all follow-up assessments (2, 8, 16, & 24-weeks post-op)
|
協力者と研究者
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。
RICEの臨床試験
-
Singapore General HospitalJanssen, LP募集