Value of Continuous Passive Motion in Rehabilitation After Total Knee Replacement

April 19, 2024 updated by: Erol Gercek, Johannes Gutenberg University Mainz

Value of Continuous Passive Motion in Rehabilitation After Total Knee Replacement - A Prospective Randomized Controlled Multicenter Trial.

Immediate rehabilitation after total knee arthroplasty (TKA) differs in terms of volume, intensity but also type of treatment. Continuous passive motion after TKA is so far only investigated for replacing physiotherapy. This study is conducted to investigate CPM when it partially replaces group physiotherapy in terms of functional and patient-reported outcomes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The aim of this study is to analyze the value (knee function, pain, and quality of life) of continuous passive motion (CPM) after total knee replacement (TKR), when it partially replaces group physiotherapy (PT) in inpatient rehabilitation to save human resources. Patients are randomized to CPM group, consisting of 3 daily sessions of 20 minutes each, or to group PT, consisting of 25 minutes physiotherapy in groups 5 days weekly. Multimodal rehabilitation does not differ for both groups throughout the 3-week rehabilitation stay.

Primary outcome is the Staffelstein Score, German standard score in rehabilitation. Secondary outcomes are Oxford Knee Score (OKS), active and passive range of motion (ROM), and pain on visual analogue scale (VAS). Return to work is assessed by post-operative days.

Study Type

Interventional

Enrollment (Actual)

175

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
    • Rheinland-Pfalz
      • Mainz, Rheinland-Pfalz, Germany, 55131
        • Universitaetsmedizin der JGU Mainz

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Total knee arthroplasty because of knee osteoarthritis
  • Inpatient rehabilitation in participating clinics

Exclusion Criteria:

  • Pregnancy
  • Not able to give informed consent
  • Psychological disorders
  • Body weight > 150 kg
  • Hip range of motion < 50°

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: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Patients in inpatient rehabilitation randomly assigned to this group Assigned intervention: CPM the
Invervention group
Device: Continuous passive motion
Daily application of continuous passive motion
Other: Patients in inpatient rehabilitation randomly assigned to this group Assigned intervention: group p
Control group
Other: standard rehabilitation
standard rehabilitation program with group physiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Staffelstein Score
Time Frame: baseline (t0) and 3 weeks later (t1)
A maximum score of 120 points is possible including 3 sub dimensions with a maximum score of 40 points each. Sub dimensions consist of pain, activities of daily life (ADL), and ROM. The Staffelstein Score is assessed by a professional investigator. Higher scores indicated better results.
baseline (t0) and 3 weeks later (t1)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oxford Knee Score (OKS)
Time Frame: baseline (t0), 10 days after baseline (t1), 3 weeks after baseline (t2), 4 months after baseline (t3)
Assessing patient's functional status. A maximum score of 48 points is possible including 12 questions with 0 - 4 points for each question [12]. Higher scores indicated better functional outcomes.
baseline (t0), 10 days after baseline (t1), 3 weeks after baseline (t2), 4 months after baseline (t3)
Range of motion (ROM)
Time Frame: baseline (t0), 10 days after baseline (t1), 3 weeks after baseline
Range of motion (ROM): Assessing the patient's knee range of motion with a mechanical goniometer
baseline (t0), 10 days after baseline (t1), 3 weeks after baseline
Visual Analogue Scale (VAS)
Time Frame: baseline (t0), 10 days after baseline (t1), 3 weeks after baseline (t2)
The patient rates pain during rest and during movement and draws a vertical line on a 10cm line with 0 cm indicating no pain and 10 cm indicating maximum pain
baseline (t0), 10 days after baseline (t1), 3 weeks after baseline (t2)
Return to work
Time Frame: baseline (t0), 4 months after baseline (t3)
Assessed by post-operative days until first day of work
baseline (t0), 4 months after baseline (t3)

Collaborators and Investigators

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

Sponsor

Johannes Gutenberg University Mainz

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 (Actual)

June 25, 2019

Primary Completion (Actual)

March 31, 2020

Study Completion (Actual)

March 31, 2020

Study Registration Dates

First Submitted

April 5, 2024

First Submitted That Met QC Criteria

April 19, 2024

First Posted (Actual)

April 24, 2024

Study Record Updates

Last Update Posted (Actual)

April 24, 2024

Last Update Submitted That Met QC Criteria

April 19, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CPMvsPT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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