NCT01186211

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
177

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 19, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 23, 2010

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2010

Completed
8.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 18, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 18, 2019

Completed
Last Updated

September 6, 2019

Status Verified

September 1, 2019

Enrollment Period

8.6 years

First QC Date

August 19, 2010

Last Update Submit

September 3, 2019

Conditions

Keywords

knee, joint

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

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.

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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 120 patients (full intervention) will be geared for same day discharge using the successful protocol already in place for unicompartment knee arthroplasty (UKA) at TOH.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ottawa General Hospital

Ottawa, Ontario, H1H 8L6, Canada

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Geoffrey Dervin, MD,MSc,FRCSC

    OHRI / The Ottawa Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2010

First Posted

August 23, 2010

Study Start

November 1, 2010

Primary Completion

June 18, 2019

Study Completion

June 18, 2019

Last Updated

September 6, 2019

Record last verified: 2019-09

Locations