Feasibility of Outpatient Total Knee Arthroplasty

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Ottawa Hospital Research Institute
Sponsor:
Information provided by (Responsible Party):
Dr. G. Dervin, Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT01186211
First received: August 19, 2010
Last updated: October 17, 2014
Last verified: October 2014
  Purpose

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.


Condition
Total Knee Replacement

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Feasibility of Outpatient Total Knee Arthroplasty

Resource links provided by NLM:


Further study details as provided by Ottawa Hospital Research Institute:

Primary Outcome Measures:
  • Pain dairy [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 60
Study Start Date: November 2010
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

Detailed Description:

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, 2015 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.

  Eligibility

Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

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 20 patients (full intervention) will be geared for same day discharge using the successful protocol already in place for unicompartment knee arthroplasty (UKA) at TOH.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01186211

Contacts
Contact: Geoffrey Dervin, MD,MSc,FRCSC (613)737-8081 gdervin@ottawahospital.on.ca

Locations
Canada, Ontario
The Ottawa General Hospital Recruiting
Ottawa, Ontario, Canada, H1H 8L6
Contact: Geoffrey Dervin MD, MSc,FRCSC    (613)737-8081    gdervin@ottawahospital.on.ca   
Principal Investigator: Geoffrey Dervin MD, MSc,FRCSC         
Sponsors and Collaborators
Ottawa Hospital Research Institute
Investigators
Principal Investigator: Geoffrey Dervin, MD,MSc,FRCSC OHRI / The Ottawa Hospital
  More Information

No publications provided

Responsible Party: Dr. G. Dervin, Chair, Orthopaedic Surgery, Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT01186211     History of Changes
Other Study ID Numbers: OHREB2010262-01H
Study First Received: August 19, 2010
Last Updated: October 17, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by Ottawa Hospital Research Institute:
Total Knee Arthroplasty (TKA)
Modified Length of Stay (MLOS)

ClinicalTrials.gov processed this record on October 23, 2014