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Feasibility of Outpatient Total Knee Arthroplasty

3. september 2019 opdateret af: Ottawa Hospital Research Institute
This proposal outlines the investigators plan to develop, evaluate and implement an accelerated in hospital and community rehabilitation following total knee arthroplasty (TKA) leading to outpatient TKA. The benefits of applying current concepts of improved postoperative analgesia and less invasive surgical technique are expected to improve objective parameters of knee function, increase patients satisfaction, while reducing health care resources requirements as compared with standard rehabilitation. The innovation of combining best practices from orthopaedic sports medicine, Anesthesia, Physiotherapy and Knee reconstruction are expected to realize this goal.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

Consecutive patients presenting for elective TKA at the General (Dr. Dervin) will be approached for enrollment.

Dr Dervin will present the study to their patients who are appropriate for the study when first confirmed for joint replacement after clinic assessment. If the patient has indicated that they are interested, the surgeon will inform the research coordinator who will then continue the consenting process. The research coordinator will confirm patient's eligibility to ensure that all inclusion and no exclusion criteria are met. The study will be explained in detail to qualify patients and they will be provided with a copy of the consent form. The consent form will also provide a clause of confidentiality informing patient privacy. All questions will be answered. Patients may also talk to the investigators with any additional questions.

Patients will be advised preoperatively about an accelerated path while in hospital that will share many attributes of the standard TOH care map,but with several additions, chosen to help reduce pain and hemarthrosis, both felt to be the major impediments to faster recuperation.

  1. Surgery will be performed with a muscle sparing subvastus approach, chosen because of evidenced decreased pain.
  2. Tranexamic acid ( 10 mg/kg) intravenously will be administered to further reduce blood loss at time of tourniquet deflation.
  3. The "Game Ready" cold - compression device will be used post operatively to help reduce pain and minimize swelling.

    .

Timeline:

Outcome data collection is expected to be completed by July 1, 2018 to allow for a minimum 6 month follow up.

Outcomes (Metrics):

The outcome measures are provided and are summarized here.

  1. Length of stay: We will measure LOS for these patients as compared to a cohort that is comparable in demographics who are being treated concurrently on the service
  2. Analgesic use in hospital and at home (where pt will maintain a 28 day pain diary to record analgesics taken and quality of life recovery questions) to be captured with special interest to any opioid sparing effect
  3. Physiotherapy will measure the Physical parameters such as range of motion and quadriceps strength during stay and at discharge, 2 weeks , and 1 , 2 and 3 months
  4. Patient satisfaction questionnaire outcome: after 6 months to evaluate
  5. Health care resource requirement

    1. Physiotherapy visits
    2. Use of mobility aids duration
  6. Time to return to work where applicable

Benefits to patient The benefits to the patient will be substantial by improving the pace of recovery with less physical burden and quicker achievement of goals and resumption of normal activity.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

177

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Ontario
      • Ottawa, Ontario, Canada, H1H 8L6
        • The Ottawa General Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

50 år til 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

The first 20 patients (baseline) will be treated in hospital so we can gauge the potential of inpatient stay and our criteria will be refined. The next group of 20 (intermediate) will be geared toward overnight stay and finally the last 120 patients (full intervention) will be geared for same day discharge using the successful protocol already in place for unicompartment knee arthroplasty (UKA) at TOH.

Beskrivelse

Inclusion Criteria:

  • Must be candidate for Total knee arthroplasty
  • Patient of Dr Dervin
  • Male or Female
  • Age range between 50-75yrs,
  • A Subvastus approach can be used

Patients who do not meet any exclusion criteria.

Exclusion Criteria:

  • Over 75 of age
  • Poor health issues
  • Revised surgery on same knee
  • Pt with evidence of active infection
  • Pt with a BMI larger than 30kg/m2

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Patients presenting for elective TKA
Patients will be advised preoperatively about an accelerated path while in hospital that will share many attributes of the standard TOH care map but with several additions, chosen to help reduce pain and hemarthrosis, both felt to be the major impediments to faster recuperation.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Pain dairy
Tidsramme: 28 days
measuring pain location,pain intensity, quality of pain, satisfaction with pain management, report any side effects, Quality of recovery, Pain medication schedule, Cryocuff schedule for Game Ready device
28 days

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Geoffrey Dervin, MD,MSc,FRCSC, OHRI / The Ottawa Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. november 2010

Primær færdiggørelse (Faktiske)

18. juni 2019

Studieafslutning (Faktiske)

18. juni 2019

Datoer for studieregistrering

Først indsendt

19. august 2010

Først indsendt, der opfyldte QC-kriterier

20. august 2010

Først opslået (Skøn)

23. august 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. september 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. september 2019

Sidst verificeret

1. september 2019

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • OHREB2010262-01H

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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