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

13 juli 2016 bijgewerkt door: 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.

Studie Overzicht

Toestand

Beëindigd

Conditie

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Werkelijk)

122

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • Utah
      • Salt Lake City, Utah, Verenigde Staten, 84108
        • University Of Utah Orthopedics Center

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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.

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Observatiemodellen: Case-control
  • Tijdsperspectieven: Prospectief

Cohorten en interventies

Groep / Cohort
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)

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Immersion Therapy
Tijdsspanne: 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
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Short Musculoskeletal Function Assessment
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of Utah

Onderzoekers

  • Hoofdonderzoeker: Erik Kubiak, MD, University of Utah Orthopedics

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 juni 2009

Primaire voltooiing (Werkelijk)

1 april 2016

Studie voltooiing (Werkelijk)

1 april 2016

Studieregistratiedata

Eerst ingediend

22 augustus 2011

Eerst ingediend dat voldeed aan de QC-criteria

19 oktober 2011

Eerst geplaatst (Schatting)

21 oktober 2011

Updates van studierecords

Laatste update geplaatst (Schatting)

14 juli 2016

Laatste update ingediend die voldeed aan QC-criteria

13 juli 2016

Laatst geverifieerd

1 juni 2016

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 34409

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