Feasibility of Outpatient Total Knee Arthroplasty
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|ClinicalTrials.gov Identifier: NCT01186211|
Recruitment Status : Active, not recruiting
First Posted : August 23, 2010
Last Update Posted : March 26, 2018
|Condition or disease|
|Osteoarthritis Of Knee|
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.
Outcome data collection is expected to be completed by July 1, 2018 to allow for a minimum 6 month follow up.
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.
|Study Type :||Observational|
|Actual Enrollment :||177 participants|
|Official Title:||Feasibility of Outpatient Total Knee Arthroplasty|
|Study Start Date :||November 2010|
|Estimated Primary Completion Date :||July 2018|
|Estimated Study Completion Date :||January 2019|
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.
- Pain dairy [ Time Frame: 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01186211
|The Ottawa General Hospital|
|Ottawa, Ontario, Canada, H1H 8L6|
|Principal Investigator:||Geoffrey Dervin, MD,MSc,FRCSC||OHRI / The Ottawa Hospital|