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Early Standardized Weight Bearing Utilizing Immersion Therapy Following Periarticular Lower Extremity Fractures

2016년 7월 13일 업데이트: Eric Kubiak, University of Utah

Early Standardized Weight Bearing Utilizing Immersion Therapy Following Periarticular Lower Extremity Fractures: Clinical and Radiographic Outcomes

The purpose of this prospective study is evaluate the effect of a standardized early weight bearing physical therapy protocol that utilizes immersion therapy on the clinical outcomes of lower extremity periarticular fractures. The investigators null hypothesis is that the early weight bearing protocol will have the same effect as a traditional 10-week non-weight bearing protocol on clinical outcomes.

연구 개요

상태

종료됨

상세 설명

Fractures of the lower extremity are common injuries that can lead to temporary or permanent disability.13 Fracture healing, regardless of treatment, is a multifactorial process that is influenced by time, biomechanics, and host biology (among other variables). The degree, timing, progression, and type of weight bearing after fractures involving the pelvis and lower extremities is an area of debate in the clinical management of a broad spectrum of orthopedic injuries.1,2,4-9,11,15 Periarticular fractures of weight bearing joints are an area of particular interest with regard to post-operative weight bearing due to the prolonged periods that patients must be non-weight bearing after surgery.

Some degree of impairment is inevitable with any traumatic injury. The majority of authors writing about post-fracture weight bearing have determined that timing and extent of weight bearing has an effect on fracture healing, while a small number of authors have published results demonstrating the opposite.14,16,19,21 In addition to potential impacts on healing rates, limited or non-weight bearing carries the added insult of loss of bone density and muscle mass.3,10,12,17,20,22

Traditionally, patients with periarticular fractures have been required to be non-weight bearing on their effected extremity for up to 12 weeks. At this institution, most patients have been required to remain non-weight bearing for 10 weeks, followed by progressively increased levels of weight bearing according to patient tolerance. One of the orthopaedic traumatologists at this institution uses immersion therapy to allow patients with periarticular fractures to begin weight bearing prior to the ten-week mark.

Immersion therapy requires that patients perform their physical therapy, with a trained therapist, in a swimming pool. The use of the pool in post-fracture care may be able to provide a structured and standardized partial weight-bearing environment that could allow for early mobilization. It also has the potential to improve clinical outcomes by mitigating at least some of the loss in bone and muscle mass during the post-operative period; thereby, potentially speeding functional recovery. Immersion therapy is currently utilized on-site at the University of Utah Orthopedic Center for a variety of diagnoses, including in post-fracture care.

There is essentially no orthopedic literature regarding immersion therapy in the management of post-fracture rehabilitation with regard to early weight bearing. Specifically, the investigators are aware of no clinical outcome studies that investigate standardized early weight bearing protocols following periarticular fractures of the lower extremity.

연구 유형

관찰

등록 (실제)

122

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

    • Utah
      • Salt Lake City, Utah, 미국, 84108
        • University Of Utah Orthopedics Center

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

샘플링 방법

비확률 샘플

연구 인구

This study is a prospective cohort study with a retrospective chart review. Patients who are treated by the PI, Dr. Erik Kubiak, will participate in an immersion therapy post-operative protocol. Immersion therapy post-operative protocols have been and are currently used routinely by Dr. Kubiak.

Patients who are treated by Dr. Dan Horwitz and Dr. Thomas Higgins will undergo a traditional 10 week non-weight bearing post-operative care per their standard of procedure. In addition, patients of Dr. Kubiak who are unable to participate in immersion therapy for logistical reasons will be asked to participate in the traditional 10- week non-weight bearing post-operative care protocol. These patients will make up the control cohort.

설명

Inclusion Criteria:

  • Inclusion criteria for the patient population under study consists of both male and female adults, at least 18 years old, who are treated for periarticular fractures of the lower extremity. The periarticular fractures included in this study will be: acetabular, tibial plateau, tibial plafond fractures.

Exclusion Criteria:

  • Age <18 years
  • Wound complications deemed to be unsafe for immersion.
  • Multiple extremity articular fractures
  • Other injuries that preclude their safe participation in physical therapy.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 관찰 모델: 케이스 컨트롤
  • 시간 관점: 유망한

코호트 및 개입

그룹/코호트
Immersion Therapy- Study
1. Patients who participate in the immersion therapy post-operative protocol and begin progressive weight bearing at 4 weeks (study)
Control Group
2. Patients who undergo the traditional 10-week non-weight bearing post-operative care protocol (control)

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Immersion Therapy
기간: 10 weeks
  1. Standard ROM while in the hospital
  2. two weeks of immersion therapy, patients perform their physical therapy immersed in the pool to their neck (5-10% total body weight).
  3. weeks 6-8, patients are immersed to their mid-chest (nipple level- 15-30% total body weight).
  4. weeks 8-10, patients are progressed to physical therapy while immersed only to their waist (navel level- 50-60% total body weight).
  5. ten weeks, patients are allowed to weight bear as tolerated and begin formal dry land ambulation training under the supervision of a licensed physical therapist .
10 weeks
Traditional non-weightbearing
기간: 10 weeks
  1. ROM therapy initiated in the hospital.
  2. Passive Motion therapy for 4 weeks.
  3. Formal physical therapy continued as needed
10 weeks

2차 결과 측정

결과 측정
측정값 설명
기간
Short Musculoskeletal Function Assessment
기간: 1 year
  • Time to return to work. Assessed at each clinical visit, and by mailings if necessary.
  • Standard radiographs will be obtained from the study patients per usual at post-operative visits. Any loss of fixation will be assessed. No additional radiographs will be obtained outside of the current standard of care.
  • Adverse events will be tabulated.
  • The short Musculoskeletal Function Assessment (SMFA) will be administered at patient's 3 month, 6 month and 1 year follow-up clinic appointments and/or by mail, as necessary.
1 year

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

수사관

  • 수석 연구원: Erik Kubiak, MD, University of Utah Orthopedics

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2009년 6월 1일

기본 완료 (실제)

2016년 4월 1일

연구 완료 (실제)

2016년 4월 1일

연구 등록 날짜

최초 제출

2011년 8월 22일

QC 기준을 충족하는 최초 제출

2011년 10월 19일

처음 게시됨 (추정)

2011년 10월 21일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2016년 7월 14일

QC 기준을 충족하는 마지막 업데이트 제출

2016년 7월 13일

마지막으로 확인됨

2016년 6월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 34409

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