Feasibility of Outpatient Total Knee Arthroplasty

Osteoarthritis Of Knee Clinical Trial

Official title:

Feasibility of Outpatient Total Knee Arthroplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01186211
• Other study ID #: OHREB2010262-01H
• Status: Completed
• Start date: November 1, 2010
• Est. completion date: June 18, 2019

Study information

• Verified date: September 2019
• Source: Ottawa Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

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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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 177
• Est. completion date: June 18, 2019
• Est. primary completion date: June 18, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis Of Knee
• Osteoarthritis, Knee

Locations

Country	Name	City	State
Canada	The Ottawa General Hospital	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain dairy	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