Inpatient Versus Outpatient Rehabilitation After TKA

May 19, 2017 updated by: Anett Mau-Moeller, University of Rostock

Inpatient Versus Outpatient Rehabilitation Following Total Knee Arthroplasty

The purpose of this study is to compare the effectiveness of inpatient and outpatient rehabilitation following total knee arthroplasty. No studies exist that have evaluated these two rehabilitation programmes in a specific orthopaedic patient population with a focus on motor performance. We hypothesized that patients participating in outpatient care tend to be physically more active than patients in the rehabilitation clinic, leading to the assumption that outpatient rehabilitation has superior functional outcomes compared to the inpatient standard-of-care therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Rostock, Germany, 18057
        • Department of Orthopedics, University Medicine Rostock

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients with knee osteoarthritis and scheduled for primary TKA
  • age: 50-80

Exclusion Criteria:

  • BMI > 40
  • musculoskeletal and neurological disorders that limit physical function
  • any planned further joint surgery within 6 months
  • substantial pain or functional limitation which make the patients unable to perform study procedures

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: inpatient rehabilitation
After discharge, patients participate in daily physical therapy for 3 weeks in a rehabilitation hospital.
Other: inpatient rehabilitation
Experimental: outpatient rehabilitation
After discharge, patients participate in daily physical therapy for 3 weeks in an outpatient rehabilitation center.
Other: outpatient rehabilitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
physical activity (number of steps)
Time Frame: during the first seven days of rehabilitation and 3 months post surgery (posttest)
over a period of 7 days using activPAL activity recording system
during the first seven days of rehabilitation and 3 months post surgery (posttest)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
gait performance
Time Frame: posttest (3 months after surgery)
spatio-temporal and temprophasic gait parameters
posttest (3 months after surgery)
maximal active and passive knee joint range of motion
Time Frame: change from baseline (9 days after surgery) to posttest (3 months after surgery)
digital long-arm goniometer
change from baseline (9 days after surgery) to posttest (3 months after surgery)
stair climbing performance
Time Frame: change from baseline (9 days after surgery) to posttest (3 months after surgery)
stair climbing test
change from baseline (9 days after surgery) to posttest (3 months after surgery)
timed up and go performance
Time Frame: change from baseline (9 days after surgery) to posttest (3 months after surgery)
timed up and go test
change from baseline (9 days after surgery) to posttest (3 months after surgery)
joint position sense
Time Frame: change from baseline (9 days after surgery) to posttest (3 months after surgery)
The subjects' ability to actively reproduce a previously presented knee flexion angle (30° and 50° of knee Flexion)
change from baseline (9 days after surgery) to posttest (3 months after surgery)
knee pain
Time Frame: change from baseline (9 days after surgery) to posttest (3 months after surgery)
visual analogue scale
change from baseline (9 days after surgery) to posttest (3 months after surgery)
knee joint swelling
Time Frame: change from baseline (9 days after surgery) to posttest (3 months after surgery)
measurement of circumference
change from baseline (9 days after surgery) to posttest (3 months after surgery)
long-term Memory representation of the gait
Time Frame: change from baseline (9 days after surgery) to posttest (3 months after surgery)
structural dimensional analysis of mental representation (SDA-M)
change from baseline (9 days after surgery) to posttest (3 months after surgery)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rostock

Investigators

  • Study Chair: Philipp Bergschmidt, MD, Department of Orthopedics, University Medicine Rostock
  • Study Director: Wolfram Mittelmeier, MD, Department of Orthopedics, University Medicine Rostock
  • Principal Investigator: Stephan Tohtz, MD, Klinik für Orthopädie und Unfallchirurgie, HELIOS Klinikum Emil von Behring GmbH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

April 17, 2014

First Submitted That Met QC Criteria

April 17, 2014

First Posted (Estimate)

April 22, 2014

Study Record Updates

Last Update Posted (Actual)

May 23, 2017

Last Update Submitted That Met QC Criteria

May 19, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ESAR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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