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
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Florida
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Orlando, Florida, 미국, 32804
- Florida Hospital
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: RICE (control)
Standard of Care procedures including ice and elevation.
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SOC ice and elevation
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실험적: Cryocompression (experimental)
treatment using the GameReady cryotherapy system
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Cryotherapy and compression
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Time until surgery/Time until discharge (LOS)
기간: 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.
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Reduction in length of stay (LOS) and time of effect (pre-/post-op)
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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.
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Change in Swelling as measured by point of largest swollen area (tape measure)
기간: Measured at baseline and all follow-up assessments (2, 8, 16, & 24-weeks post-op)
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Measured at circumference of swelling point
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Measured at baseline and all follow-up assessments (2, 8, 16, & 24-weeks post-op)
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Total Narcotic Use as recorded on MR chart and Knee Pain Assessment
기간: Measured daily while inpatient (approx 2-3 days) and retroactively at all follow-up assessments (2, 8, 16, & 24-weeks post-op)
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reported as yes/no and amount/type on assessment form
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Measured daily while inpatient (approx 2-3 days) and retroactively at all follow-up assessments (2, 8, 16, & 24-weeks post-op)
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Change in Patient reported pain as measured on VAS and Knee Pain Assessment
기간: Reported at baseline, daily while inpatient (approx 2-3 days), and at all follow-up assessments (2, 8, 16, & 24-weeks post-op)
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As reported by VAS scale
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Reported at baseline, daily while inpatient (approx 2-3 days), and at all follow-up assessments (2, 8, 16, & 24-weeks post-op)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Quality of Life (QALY) as measured on QOL and SF-8
기간: At baseline and all follow-up assessments (2, 8, 16, & 24-weeks post-op)
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Quality of Life by QALY score
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At baseline and all follow-up assessments (2, 8, 16, & 24-weeks post-op)
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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RICE에 대한 임상 시험
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Singapore General HospitalJanssen, LP모병