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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02120313
Other study ID # ESAR
Secondary ID
Status Completed
Phase N/A
First received April 17, 2014
Last updated May 19, 2017
Start date April 2014
Est. completion date June 2016

Study information

Verified date May 2017
Source University of Rostock
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 42
Est. completion date June 2016
Est. primary completion date March 2016
Accepts healthy volunteers No
Gender All
Age group 50 Years to 80 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
inpatient rehabilitation

outpatient rehabilitation


Locations

Country Name City State
Germany Department of Orthopedics, University Medicine Rostock Rostock

Sponsors (1)

Lead Sponsor Collaborator
University of Rostock

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary physical activity (number of steps) 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 gait performance spatio-temporal and temprophasic gait parameters posttest (3 months after surgery)
Secondary maximal active and passive knee joint range of motion digital long-arm goniometer change from baseline (9 days after surgery) to posttest (3 months after surgery)
Secondary stair climbing performance stair climbing test change from baseline (9 days after surgery) to posttest (3 months after surgery)
Secondary timed up and go performance timed up and go test change from baseline (9 days after surgery) to posttest (3 months after surgery)
Secondary joint position sense 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)
Secondary knee pain visual analogue scale change from baseline (9 days after surgery) to posttest (3 months after surgery)
Secondary knee joint swelling measurement of circumference change from baseline (9 days after surgery) to posttest (3 months after surgery)
Secondary long-term Memory representation of the gait structural dimensional analysis of mental representation (SDA-M) change from baseline (9 days after surgery) to posttest (3 months after surgery)
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