- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT01186211
Feasibility of Outpatient Total Knee Arthroplasty
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Kontakte und Standorte
Studienorte
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Ontario
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Ottawa, Ontario, Kanada, H1H 8L6
- The Ottawa General Hospital
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
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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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Pain dairy
Zeitfenster: 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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Mitarbeiter und Ermittler
Ermittler
- Hauptermittler: Geoffrey Dervin, MD,MSc,FRCSC, OHRI / The Ottawa Hospital
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- OHREB2010262-01H
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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