Inpatient Versus Outpatient Rehabilitation After TKA

NCT02120313 | Completed

• 1 other identifier: ESAR
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Total Knee Arthroplasty

Keywords

rehabilitation; total knee arthroplasty

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• gait performance

  posttest (3 months after surgery)

• maximal active and passive knee joint range of motion

  change from baseline (9 days after surgery) to posttest (3 months after surgery)

• stair climbing performance

  change from baseline (9 days after surgery) to posttest (3 months after surgery)

• timed up and go performance

  change from baseline (9 days after surgery) to posttest (3 months after surgery)

• joint position sense

  change from baseline (9 days after surgery) to posttest (3 months after surgery)

Study Arms (2)

inpatient rehabilitation

ACTIVE COMPARATOR

After discharge, patients participate in daily physical therapy for 3 weeks in a rehabilitation hospital.

Other: inpatient rehabilitation

outpatient rehabilitation

EXPERIMENTAL

After discharge, patients participate in daily physical therapy for 3 weeks in an outpatient rehabilitation center.

Other: outpatient rehabilitation

Interventions

inpatient rehabilitation OTHER

inpatient rehabilitation

outpatient rehabilitation OTHER

outpatient rehabilitation

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Rostock: lead

Study Sites (1)

Department of Orthopedics, University Medicine Rostock

Rostock, 18057, Germany

Location

Related Links

• Stiftung Oskar Helene Heim

Study Officials

• Philipp Bergschmidt, MD

  Department of Orthopedics, University Medicine Rostock

  STUDY CHAIR

• Wolfram Mittelmeier, MD

  Department of Orthopedics, University Medicine Rostock

  STUDY DIRECTOR

• Anett Mau-Moeller, M.A.

  Department of Orthopedics, University Medicine Rostock

  PRINCIPAL INVESTIGATOR

• Stephan Tohtz, MD

  Klinik für Orthopädie und Unfallchirurgie, HELIOS Klinikum Emil von Behring GmbH

  PRINCIPAL INVESTIGATOR

• Martin Behrens

  Department of Kinesiology, University of Rostock

  PRINCIPAL INVESTIGATOR

• Tino Stöckel, PhD

  Department of Kinesiology, University of Rostock

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.A.

Study Record Dates

• First Submitted: April 17, 2014
• First Posted: April 22, 2014
• Study Start: April 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: June 1, 2016
• Last Updated: May 23, 2017

Record last verified: 2017-05

Locations

DE (1)