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- Klinische proef NCT01186211
Feasibility of Outpatient Total Knee Arthroplasty
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
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.
- Surgery will be performed with a muscle sparing subvastus approach, chosen because of evidenced decreased pain.
- Tranexamic acid ( 10 mg/kg) intravenously will be administered to further reduce blood loss at time of tourniquet deflation.
The "Game Ready" cold - compression device will be used post operatively to help reduce pain and minimize swelling.
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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.
- 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
- 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
- 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
- Patient satisfaction questionnaire outcome: after 6 months to evaluate
Health care resource requirement
- Physiotherapy visits
- Use of mobility aids duration
- 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.
Studietype
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
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Ontario
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Ottawa, Ontario, Canada, H1H 8L6
- The Ottawa General Hospital
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
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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.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Pain dairy
Tijdsspanne: 28 days
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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
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28 days
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Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Geoffrey Dervin, MD,MSc,FRCSC, OHRI / The Ottawa Hospital
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- OHREB2010262-01H
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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